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XYWAV calcium, magnesium, potassium, and sodium oxybates .5 g/mL; .5 g/mL; .5 g/mL; .5 g/mL Solution, 180 mL

by Jazz Pharmaceuticals, Inc. · 180 mL in 1 BOTTLE, PLASTIC (68727-150-01)
NDC 68727-0150-01
🏷️ FDA NDC (as labeled) 68727-150-01 billing pads the product segment with a zero
Rx only Brand On market CIII 🛡 REMS
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 68727-150-01
Product NDC 68727-150
11-digit billing NDC 68727015001
NCPDP billing unit ML — per mL (volume)
RxCUI 2393794, 2393795
UNII 7G33012534, 8W24SYD6ZI, S8NKF3H3KT, G983HLV265
Application # NDA212690
SPL Set ID 1e0ae43a-037f-42af-8e23-a0e51d75abe8
Established class (EPC) Central Nervous System Depressant; Central Ner
Physiologic effect Central Nervous System Depression
DEA schedule CIII
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-11-02
Route ORAL
Dosage form SOLUTION
Substance SODIUM OXYBATE; CALCIUM OXYBATE; POTASSIUM OXYBATE; MAGNESIUM OXYBATE
GPI-14 62459904202020
GPI class Xywav
GCN Seq No 081341
GCN 48419
HICL code 046743
Ingredient (HICL) Sodium,Calcium,Mag,Pot Oxybate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7W
Therapeutic class — specific (HIC3) Anti-Narcolepsy,Anti-Cataplexy,Sedative-Type Agent
AHFS code 28:20.80.00
AHFS class Wakefulness-Promoting Agents
FDB label name XYWAV 0.5 GM/ML ORAL SOLUTION
FDB brand name Xywav
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68727-150-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68727-0150-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Central Nervous System Depressant class.

Pharmacologic class Central Nervous System Depressant
Drug family (ATC) Other general anesthetics, Other nervous system drugs
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerJazz Pharmaceuticals, Inc.
Application holderJAZZ PHARMACEUTICALS IRELAND LTD
FDA applicationNDA212690 (NDA)
Labeler code68727
First marketedNov 2020
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio9 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name XYWAV 0.5 GM/ML ORAL SOLUTION Ingredient Sodium,Calcium,Mag,Pot Oxybate
📗 Our plain-language guide HelloPharmacist
  • For narcolepsy, Xywav is designed to be taken in two separate doses because it leaves your body very quickly — the half-life is less than an hour. If you took it all at once, it wo...
  • Why do I have to take this medicine in the middle of the night? Can't I just take it all at once before bed?
  • Yes, this matters a lot. Eating — especially a high-fat meal — can reduce the amount of Xywav your body absorbs by a meaningful amount. That could make it less effective or cause u...
  • Is it really that important not to eat before taking it?
📖 Read our full Calcium, Magnesium, Potassium, and Sodium Oxybate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $37.65 $6,777.88 / 180 ml
Medicare drug plans payPart D · Q2 2026 $36.92 $6,645.38 / 180 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Xywav .5 g/mL; .5 g/mL; .5 g/mL; .5 g/mLthis 68727-0150-01 Jazz 180 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
First FDA approval
Jul 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 21, 2020 RLD RS ⏳ ~14.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8772306 — method of use (U-3198)
US 11426373 — method of use (U-3432)
US 11986446 — method of use (U-3017)
US 11986446 — method of use (U-3324)
US 10675258 — method of use (U-2938)
US 9050302 — method of use (U-1532)
US 10213400 — method of use (U-2499)
US 9486426 — method of use (U-1532)
US 8772306 — method of use (U-1532)
US 10864181 — method of use (U-3017)
US 11253494 — method of use (U-3323)
US 11253494 — method of use (U-3324)
US 12138233 — method of use (U-4044)
US 12582622 — method of use (U-4044)
US 9132107 — drug product
US 8901173 — drug product
US 10195168 — drug product
US 8591922 — drug product
US 11554102 — drug product
US 10213400*PED — drug product
US 11253494*PED — drug product
US 9050302*PED — drug product
US 9486426*PED — drug product
US 8772306*PED — drug product
US 10864181*PED — drug product
Exclusivity ODE-361
Exclusivity ODE-369
Exclusivity PED
2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (25)
PatentTypeUse codeExpires
US 8772306 ↗ Method of use U-3198 Mar 15, 2033
US 11426373 ↗ Method of use U-3432 Sep 19, 2037
US 11986446 ↗ Method of use U-3017 Mar 15, 2033
US 11986446 ↗ Method of use U-3324 Mar 15, 2033
US 10675258 ↗ Method of use U-2938 Jan 11, 2033
US 9050302 ↗ Method of use U-1532 Mar 15, 2033
US 10213400 ↗ Method of use U-2499 Mar 15, 2033
US 9486426 ↗ Method of use U-1532 Mar 15, 2033
US 8772306 ↗ Method of use U-1532 Mar 15, 2033
US 10864181 ↗ Method of use U-3017 Mar 15, 2033
US 11253494 ↗ Method of use U-3323 Mar 15, 2033
US 11253494 ↗ Method of use U-3324 Mar 15, 2033
US 12138233 ↗ Method of use U-4044 Feb 22, 2041
US 12582622 ↗ Method of use U-4044 Feb 22, 2041
US 9132107 ↗ Drug product — Jan 11, 2033
US 8901173 ↗ Drug product — Jan 11, 2033
US 10195168 ↗ Drug product — Jan 11, 2033
US 8591922 ↗ Drug product — Jan 11, 2033
US 11554102 ↗ Drug product — Jan 11, 2033
US 10213400*PED ↗ Drug product — Sep 15, 2033
US 11253494*PED ↗ Drug product — Sep 15, 2033
US 9050302*PED ↗ Drug product — Sep 15, 2033
US 9486426*PED ↗ Drug product — Sep 15, 2033
US 8772306*PED ↗ Drug product — Sep 15, 2033
US 10864181*PED ↗ Drug product — Sep 15, 2033
FDA exclusivity
CodeWhat it grantsExpires
ODE-361Orphan Drug Exclusivity (7-year)Jul 21, 2027
ODE-369Orphan Drug Exclusivity (7-year)Aug 12, 2028
PEDPediatric Exclusivity (+6 months)Jan 21, 2028
Common questions
Is there a generic version of XYWAV 0.5 GM/ML ORAL SOLUTION?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for XYWAV 0.5 GM/ML ORAL SOLUTION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68727-0150-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
9.3K
Units reimbursed last 4 qtrs
4.1M
Gross reimbursed last 4 qtrs
$155.01M
Avg / prescription
$16,732.51
Avg / unit
$37.6549
Latest quarter Q1 2026
2.1KRx
Fee-for-service vs managed care ⓘ
25% FFS 75% MCO
Fee-for-service · 2,333 Rx Managed care · 6,931 Rx
State Medicaid map
Alaska: no data reported AK Maine: 20,430 units · 1,465 per 100k residents ME Washington: 150,750 units · 1,930 per 100k residents WA Idaho: 33,930 units · 1,728 per 100k residents ID Montana: 30,240 units · 2,671 per 100k residents MT North Dakota: no data reported ND Minnesota: 70,920 units · 1,236 per 100k residents MN Wisconsin: 58,680 units · 993 per 100k residents WI Michigan: 153,720 units · 1,532 per 100k residents MI New York: 161,460 units · 825 per 100k residents NY Vermont: no data reported VT New Hampshire: 8,550 units · 610 per 100k residents NH Oregon: 90,720 units · 2,143 per 100k residents OR Nevada: 3,960 units · 124 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 94,500 units · 2,947 per 100k residents IA Illinois: 167,580 units · 1,335 per 100k residents IL Indiana: 248,580 units · 3,623 per 100k residents IN Ohio: 494,550 units · 4,196 per 100k residents OH Pennsylvania: 225,360 units · 1,739 per 100k residents PA New Jersey: 90,270 units · 972 per 100k residents NJ Massachusetts: 65,520 units · 936 per 100k residents MA California: 303,570 units · 779 per 100k residents CA Utah: 51,120 units · 1,496 per 100k residents UT Colorado: 93,960 units · 1,599 per 100k residents CO Nebraska: 45,360 units · 2,293 per 100k residents NE Missouri: 63,810 units · 1,030 per 100k residents MO Kentucky: 128,790 units · 2,846 per 100k residents KY West Virginia: no data reported WV Virginia: 242,640 units · 2,784 per 100k residents VA Maryland: 49,770 units · 805 per 100k residents MD Connecticut: 116,730 units · 3,227 per 100k residents CT Rhode Island: no data reported RI Arizona: 95,940 units · 1,291 per 100k residents AZ New Mexico: 38,250 units · 1,809 per 100k residents NM Kansas: 39,600 units · 1,347 per 100k residents KS Arkansas: 4,320 units · 141 per 100k residents AR Tennessee: 72,540 units · 1,018 per 100k residents TN North Carolina: 157,140 units · 1,450 per 100k residents NC South Carolina: 68,220 units · 1,270 per 100k residents SC Delaware: no data reported DE Oklahoma: 36,270 units · 895 per 100k residents OK Louisiana: 95,040 units · 2,078 per 100k residents LA Mississippi: no data reported MS Alabama: 30,510 units · 597 per 100k residents AL Georgia: 28,710 units · 260 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 98,190 units · 322 per 100k residents TX Florida: 86,400 units · 382 per 100k residents FL
Units reimbursed · per 100k residents
1244,196
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 4,196 /100k
2 Indiana 3,623 /100k
3 Connecticut 3,227 /100k
4 Iowa 2,947 /100k
5 Kentucky 2,846 /100k
6 Virginia 2,784 /100k
7 Montana 2,671 /100k
8 Nebraska 2,293 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Xywav — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Xywav. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$65.43M
Claims incl. refills
3.6K
Beneficiaries
1.4K
Spend / beneficiary
$46,637.03
Spend / claim
$18,251.53
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🛡
This drug has a REMS — XYWAV and XYREM REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It is available only through a restricted program (certified prescribers/pharmacies, enrollment, or required monitoring). See the boxed warning & full label below, and REMS@FDA ↗.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for XYWAV (this brand).

Top reported reactions

Product Administration Interrupted1,528
Surgery1,238
Nausea924
Anxiety663
Intentional Dose Omission574
Dizziness512
Headache511

Age at onset

Infant1
Adolescent2
Adult157
Elderly6

Reporter sex

8,562 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization1,601
Death81
Disabling76
Life-threatening31
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,063 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68727-0150-01 You're viewing this 180 mL in 1 BOTTLE, PLASTIC (68727-150-01) 2020-11-02 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68727-150-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68727-0150-01, written without dashes as 68727015001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68727-0150-01, the first segment (68727) is the labeler code FDA assigned to Jazz Pharmaceuticals, Inc.; the middle segment (0150) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Jazz Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jazz Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses [see Warnings and Precautions ( 5.1 , 5.4 )]. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving central nervous system stimulants [see Clinical Studies ( 14.1 , 14.2 , 14.3 )]. • Abuse and Misuse The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB).

Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions ( 5.2 )]. Because of the risks of CNS depression and abuse and misuse, XYWAV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS [see Warnings and Precautions ( 5.3 )]. WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE.

See full prescribing information for complete boxed warning. Central Nervous System Depression • XYWAV is a CNS depressant, and respiratory depression can occur with XYWAV use ( 5.1 , 5.4 ) Abuse and Misuse • The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death ( 5.2 , 9.2 ) XYWAV is available only through a restricted program called the XYWAV and XYREM REMS ( 5.3 )

🎯 Indications and Usage 85 words ▾

1 INDICATIONS AND USAGE XYWAV is a central nervous system depressant indicated for the treatment of: • Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1.1 ). • Idiopathic Hypersomnia (IH) in adults ( 1.2 ).

1.1Narcolepsy XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

1.2Idiopathic Hypersomnia XYWAV is indicated for the treatment of idiopathic hypersomnia (IH) in adults.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for complete dosing instructions ( 2.1 - 2.7 ). Dosage for Adult Patients with Narcolepsy • Initiate dosage at 4.5 g per night orally, divided into two doses ( 2.1 ). • Titrate to effect in increments of up to 1.5 g per night per week ( 2.1 ). • Recommended dosage range: 6 g to 9 g per night orally, divided into two doses ( 2.1 ). • Doses may be divided equally or unequally and the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later ( 2.1 ).

Dosage for Pediatric Patients with Narcolepsy (7 Years of Age and Older) • The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight (2.2 ). Dosage for Adult Patients with Idiopathic Hypersomnia • XYWAV can be administered as a twice or once nightly regimen in adults ( 2.3 ). • Twice nightly: Initiate dosage at 4.5 g or less per night orally, divided into two doses. Titrate to effect in increments of up to 1.5 g per night per week, up to 9 g total nightly dose ( 2.3 ). • Once nightly: Initiate dosage at 3 g or less per night orally, as one dose.

Titrate to effect in increments of up to 1.5 g per night per week, up to 6 g total nightly dose ( 2.3 ). Important Administration Information • Administer XYWAV at least 2 hours after eating ( 2.4 ). • Prepare XYWAV prior to bedtime; dilute with approximately ¼ cup of water in pharmacy-provided containers ( 2.4 ). • Take XYWAV while in bed and lie down after dosing ( 2.4 ). For Patients Transitioning from Xyrem to XYWAV: Initiate at the same dose and regimen as Xyrem (gram for gram).

Titrate as needed based on efficacy and tolerability ( 2.5 ). Patients with Hepatic Impairment Recommended starting dosage is one-half of the original dosage per night administered orally, divided into two doses ( 2.6 ).

2.1Dosing Information in Adult Patients with Narcolepsy The recommended starting dosage is 4.5 grams (g) per night administered orally, divided into two doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later (see Table 1). Increase the dosage by up to 1.5 g per night per week (e.g., 0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later), to the recommended dosage range of 6 g to 9 g per night. The dosage may be gradually titrated based on efficacy and tolerability.

Some patients may achieve better responses with unequal doses at bedtime and 2.5 to 4 hours later. Doses higher than 9 g per night have not been studied and ordinarily should not be administered. Table 1: Recommended Adult XYWAV Dosage Regimen (g = grams) Note: Some patients may achieve better responses with unequal nightly doses at bedtime and 2.5 to 4 hours later.

If a Patient’s Total Nightly Dosage Is: Take at Bedtime: Take 2.5 to 4 Hours Later: 4.5 g per night 2.25 g 2.25 g 6 g per night 3 g 3 g 7.5 g per night 3.75 g 3.75 g 9 g per night 4.5 g 4.5 g

2.2Dosing Information in Pediatric Patients with Narcolepsy For pediatric patients 7 years of age and older, XYWAV is administered orally twice per night. The recommended starting pediatric dosage, titration regimen, and maximum total nightly dosage are based on patient weight, as specified in Table 2. The dosage may be gradually titrated based on efficacy and tolerability.

Doses higher than 9 g per night have not been studied and ordinarily should not be administered. Table 2: Recommended XYWAV Dosage for Patients 7 Years of Age and Older* * For patients who sleep more than 8 hours per night, the first nightly dose of XYWAV may be given at bedtime or after an initial period of sleep. ** If XYWAV is used in patients 7 years of age and older who weigh less than 20 kg, a lower starting dosage, lower maximum weekly dosage increases, and lower total maximum nightly dosage should be considered.

Note: Some patients may achieve better responses with unequal nightly doses at bedtime and 2.5 to 4 hours later. Patient Weight Initial Dosage Maximum Weekly Dosage Increase Maximum Recommended Dosage Take at B…

💊 Dosage Forms and Strengths 72 words ▾

3 DOSAGE FORMS AND STRENGTHS XYWAV is a clear to slightly opalescent oral solution at a total salt concentration of 0.5 g per mL. Each mL contains 0.5 g of total salts present as 0.234 g calcium oxybate, 0.096 g magnesium oxybate, 0.13 g potassium oxybate, and 0.04 g sodium oxybate (equivalent to 0.413 g total oxybate). Oral solution: 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate) ( 3 )

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS XYWAV is contraindicated for use in: • combination with sedative hypnotics [see Warnings and Precautions ( 5.1 )] . • combination with alcohol [see Warnings and Precautions ( 5.1 , 5.2 )] . • patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology ( 12.3 )] . • In combination with sedative hypnotics or alcohol ( 4 ) • Succinic semialdehyde dehydrogenase deficiency ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • CNS depression: Use caution when considering the concurrent use of XYWAV with other CNS depressants ( 5.1 ). • Caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that XYWAV does not affect them adversely ( 5.1 ). • Depression and suicidality: Monitor patients for emergent or increased depression and suicidality ( 5.5 ). • Confusion/Anxiety: Monitor for impaired motor/cognitive function ( 5.6 ). • Parasomnias: Evaluate episodes of sleepwalking ( 5.7 ).

5.1Central Nervous System Depression XYWAV is a central nervous system (CNS) depressant. Clinically significant respiratory depression and obtundation has occurred in adult patients taking sodium oxybate (same active moiety as XYWAV) at recommended doses in clinical trials and may occur in patients treated with XYWAV at recommended doses. XYWAV is contraindicated in combination with alcohol and sedative hypnotics.

The concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered.

In addition, if short-term use of an opioid (e.g., post- or perioperative) is required, interruption of treatment with XYWAV should be considered. Healthcare providers should caution patients about operating hazardous machinery, including automobiles or airplanes, until they are reasonably certain that XYWAV does not affect them adversely (e.g., impair judgment, thinking, or motor skills). Patients should not engage in hazardous occupations or activities requiring complete mental alertness or motor coordination, such as operating machinery or a motor vehicle or flying an airplane, for at least 6 hours after taking XYWAV.

Patients should be queried about CNS depression‐related events upon initiation of XYWAV therapy and periodically thereafter. XYWAV is available only through a restricted program under a REMS [see Warnings and Precautions ( 5.3 )] .

5.2Abuse and Misuse XYWAV is a Schedule III controlled substance. The active moiety of XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.

The rapid onset of sedation, coupled with the amnestic features of GHB, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g., assault victim). Because illicit use and abuse of GHB have been reported, healthcare providers should carefully evaluate patients for a history of drug abuse and follow them closely, particularly for signs of misuse or abuse of GHB (including but not limited to increase in size or frequency of dosing, drug-seeking behavior, feigned cataplexy) [see Drug Abuse and Dependence ( 9.2 )] .

If abuse is suspected, treatment with XYWAV should be discontinued . XYWAV is available only through a restricted program under a REMS [see Warnings and Precautions ( 5.3 )] .

5.3XYWAV and XYREM REMS XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS because of the risks of central nervous system depression, and abuse and misuse [see Warnings and Precautions ( 5.1 , 5.2 )]. Notable requirements of the XYWAV and XYREM REMS include the following: • Healthcare Providers who prescribe XYWAV are specially certified • XYWAV…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions appear in other sections of the labeling: • CNS depression [see Warnings and Precautions ( 5.1 )] • Abuse and Misuse [see Warnings and Precautions ( 5.2 )] • Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions ( 5.4 )] • Depression and Suicidality [see Warnings and Precautions ( 5.5 )] • Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Parasomnias [see Warnings and Precautions ( 5.7 )] Most common adverse reactions in adults with narcolepsy or IH (≥5%) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor ( 6.1 ).

In a pediatric study with sodium oxybate (same active moiety as XYWAV), the most common adverse reactions (≥5%) were nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1-800-520-5568, or FDA at 1-800-FDA-1088 or www.fda.gov/Medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adult Patients with Narcolepsy The safety of XYWAV was evaluated in a 16‑week double-blind placebo-controlled randomized-withdrawal study in patients with narcolepsy with cataplexy (Study 1), which was followed by an open-label extension phase lasting 24 weeks [see Clinical Studies ( 14.1 )] .

Study 1 included an open‑label titration period (OL OTTP), a stable-dose period (SDP), and a double‑blind, placebo‑controlled, randomized-withdrawal period (DB RWP). A total of 201 patients, ages 18 to 70 years, received XYWAV at individually titrated doses for 14 weeks, followed by randomization to XYWAV or matching placebo for 2 weeks of treatment. The mean exposure to XYWAV during this study, including titration, the randomized withdrawal period, and the open-label extension, was 151 days.

In patients who remained on treatment, adverse reactions tended to occur early and diminish over time. Adverse Reactions Leading to Treatment Discontinuation in Study 1 In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%).

The majority of adverse reactions leading to discontinuation began during the first few weeks of treatment. Commonly Observed Adverse Reactions The most common adverse reactions in Study 1 (incidence ≥5% of XYWAV-treated patients) were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety, and vomiting. Adverse Reactions Occurring at an Incidence of 2% or Greater: Table 4 lists adverse reactions observed in the open-label titration and stable dose periods of Study 1 that occurred at a frequency of 2% or greater in adult patients treated with XYWAV.

Table 4: Adverse Reactions Occurring in ≥2% of Adult Patients Treated with XYWAV in the Open-Label Titration and Stable Dose Periods in Study 1 * * Adverse reactions related to XYWAV were reported less frequently, as an overall incidence, in patients on Xyrem at study entry than in Xyrem-naïve patients. † Includes abnormal dreams, abnormal sleep-related event, rapid eye movements sleep abnormal, sleep paralysis, sleep talking, sleep terror, sleep-related eating disorder, somnambulism ‡ Includes hyperhidrosis and night sweats § Includes anxiety, agitation, panic attack, tension ¶ Includes fatigue and asthenia Adverse Reaction Open-Label Titrati…

🔄 Drug Interactions 171 words ▾

7 DRUG INTERACTIONS • Concomitant use with divalproex sodium: An initial reduction in XYWAV dose of at least 20% is recommended ( 2.7 , 7.2 ).

7.1Alcohol, Sedative Hypnotics, and CNS Depressants XYWAV is contraindicated for use in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of XYWAV [see Warnings and Precautions ( 5.1 )] .

7.2Divalproex Sodium Concomitant use of sodium oxybate with divalproex sodium results in an increase in systemic exposure to GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study [see Clinical Pharmacology ( 12.3 )] . A similar increase in exposure is expected with concomitant use of XYWAV and divalproex sodium; therefore, an initial dose reduction of XYWAV is recommended when used concomitantly with divalproex sodium [see Dosage and Administration ( 2.7 )].

Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of XYWAV and divalproex sodium is warranted.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ). • Geriatric patients: Monitor for impaired motor and/or cognitive function when taking XYWAV ( 8.5 ).

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of XYWAV or sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (0, 150, 350, or 1,000 mg/kg/day) or rabbits (0, 300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see Data] .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Labor or Delivery XYWAV has not been studied in labor or delivery.

In obstetric anesthesia using an injectable formulation of sodium oxybate, newborns had stable cardiovascular and respiratory measures but were very sleepy, causing a slight decrease in Apgar scores. There was a fall in the rate of uterine contractions 20 minutes after injection. Placental transfer is rapid, and gamma-hydroxybutyrate (GHB) has been detected in newborns at delivery after intravenous administration of GHB to mothers.

Subsequent effects of sodium oxybate on later growth, development, and maturation in humans are unknown. Data Animal Data Oral administration of sodium oxybate to pregnant rats (0, 150, 350, or 1,000 mg/kg/day) or rabbits (0, 300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity. The highest doses of sodium oxybate tested in rats and rabbits were approximately 1 and 3 times, respectively, the maximum recommended human dose (MRHD) of 9 g per night on a body surface area (mg/m 2 ) basis.

Additionally, oral administration of sodium oxybate (0, 150, 350, or 1,000 mg/kg/day) to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and body weight gain at the highest dose tested. The no-effect dose for pre- and post-natal developmental toxicity in rats is less than the MRHD on a mg/m 2 basis.

8.2Lactation Risk Summary GHB is excreted in human milk after oral administration of sodium oxybate. There is insufficient information on the risk to a breastfed infant, and there is insufficient information on milk production in nursing mothers. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XYWAV and any potential adverse effects on the breastfed infant from XYWAV or from the underlying maternal condition.

8.4Pediatric Use Narcolepsy The safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and well-controlled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.1 , 14.2 )].

In the pediatric clinical trial with sodium oxybate administration in patients with narcolepsy, serious adverse reactions of central sleep apnea and oxygen desaturation documented by polysomnography evaluation; depression; suicidal ideation; neurop…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of XYWAV or sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (0, 150, 350, or 1,000 mg/kg/day) or rabbits (0, 300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see Data] .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Labor or Delivery XYWAV has not been studied in labor or delivery.

In obstetric anesthesia using an injectable formulation of sodium oxybate, newborns had stable cardiovascular and respiratory measures but were very sleepy, causing a slight decrease in Apgar scores. There was a fall in the rate of uterine contractions 20 minutes after injection. Placental transfer is rapid, and gamma-hydroxybutyrate (GHB) has been detected in newborns at delivery after intravenous administration of GHB to mothers.

Subsequent effects of sodium oxybate on later growth, development, and maturation in humans are unknown. Data Animal Data Oral administration of sodium oxybate to pregnant rats (0, 150, 350, or 1,000 mg/kg/day) or rabbits (0, 300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity. The highest doses of sodium oxybate tested in rats and rabbits were approximately 1 and 3 times, respectively, the maximum recommended human dose (MRHD) of 9 g per night on a body surface area (mg/m 2 ) basis.

Additionally, oral administration of sodium oxybate (0, 150, 350, or 1,000 mg/kg/day) to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and body weight gain at the highest dose tested. The no-effect dose for pre- and post-natal developmental toxicity in rats is less than the MRHD on a mg/m 2 basis.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Narcolepsy The safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and well-controlled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.1 , 14.2 )].

In the pediatric clinical trial with sodium oxybate administration in patients with narcolepsy, serious adverse reactions of central sleep apnea and oxygen desaturation documented by polysomnography evaluation; depression; suicidal ideation; neuropsychiatric reactions including acute psychosis, confusion, and anxiety; and parasomnias, including sleepwalking, have been reported [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 ) and Adverse Reactions ( 6.1 )] . Safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients below the age of 7 years have not been established.

Idiopathic Hypersomnia Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established. Juvenile Animal Toxicity Data In a study in which sodium oxybate (0, 100, 300, or 900 mg/kg/day) was orally administered to rats during the juvenile period of development (postnatal days 21 through 90), mortality was observed at the two highest doses tested. Deaths occurred during the first week of dosing and were associated with clinical signs (including decreased activity and respiratory rate) consistent with the pharmacological effects of the drug.

Reduced body weight gain in males and females and delayed sexual maturation in males were observed at the highest dose tested. The no-effect dose for adverse effects in juvenile rats is associated with plasma exposures (AUC) less than that at the maximum recommended human dose (9 g/night).

🧓 Geriatric Use 137 words ▾

8.5Geriatric Use Clinical studies of XYWAV or Xyrem in patients with narcolepsy or IH did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects. In clinical studies of sodium oxybate in another population, 39 (5%) of 874 patients were 65 years or older. Discontinuations of treatment due to adverse reactions were increased in the elderly compared to younger adults (21% vs.

19%). Frequency of headaches was markedly increased in the elderly (39% vs. 19%).

The most common adverse reactions were similar in both age categories. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE

10.1Human Experience Information regarding overdose with XYWAV is derived largely from reports in the medical literature that describe symptoms and signs in individuals who have ingested GHB illicitly. In these circumstances the co-ingestion of other drugs and alcohol was common, and may have influenced the presentation and severity of clinical manifestations of overdose. In adult clinical trials with Xyrem (same active moiety as XYWAV), two cases of overdose were reported.

In the first case, an estimated dose of 150 g, more than 15 times the maximum recommended dose, caused a patient to be unresponsive with brief periods of apnea and to be incontinent of urine and feces. This individual recovered without sequelae. In the second case, death was reported following a multiple drug overdose consisting of Xyrem and numerous other drugs.

No cases of overdose (greater than 9 g) with XYWAV were reported in the XYWAV clinical trials.

10.2Signs and Symptoms Information about signs and symptoms associated with overdosage with XYWAV derives from reports of illicit use of GHB. Patient presentation following overdose is influenced by the dose ingested, the time since ingestion, the co-ingestion of other drugs and alcohol, and the fed or fasted state. Patients have exhibited varying degrees of depressed consciousness that may fluctuate rapidly between a confusional, agitated combative state with ataxia and coma.

Emesis (even when obtunded), diaphoresis, headache, and impaired psychomotor skills have been observed. No typical pupillary changes have been described to assist in diagnosis; pupillary reactivity to light is maintained. Blurred vision has been reported.

An increasing depth of coma and acidosis have been observed at higher doses. Myoclonus and tonic-clonic seizures have been reported. Respiration may be unaffected or compromised in rate and depth.

Cheyne-Stokes respiration and apnea have been observed. Bradycardia and hypothermia may accompany unconsciousness, as well as muscular hypotonia, but tendon reflexes remain intact.

10.3Recommended Treatment of Overdose General symptomatic and supportive care should be instituted immediately, and gastric decontamination may be considered if co-ingestants are suspected. Because emesis may occur in the presence of obtundation, appropriate posture (left lateral recumbent position) and protection of the airway by intubation may be warranted. Although the gag reflex may be absent in deeply comatose patients, even unconscious patients may become combative to intubation, and rapid-sequence induction (without the use of sedative) should be considered.

Vital signs and consciousness should be closely monitored. The bradycardia reported with GHB overdose has been responsive to atropine intravenous administration. No reversal of the central depressant effects of XYWAV can be expected from naloxone or flumazenil administration.

The use of hemodialysis and other forms of extracorporeal drug removal have not been studied in GHB overdose, but have been reported in cases of acidosis associated with GHB ingestions of 125 g or greater; however, due to the rapid metabolism of oxybate, these measures may not be warranted.

10.4Poison Control Center As with the management of all cases of drug overdosage, the possibility of multiple drug ingestion should be considered. The healthcare provider is encouraged to collect urine and blood samples for routine toxicologic screening, and to consult with a regional poison control center (1-800-222-1222) for current treatment recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action XYWAV is a CNS depressant. The exact mechanism of action of XYWAV in the treatment of narcolepsy and idiopathic hypersomnia is unknown. XYWAV is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (gamma-hydroxybutyrate).

Gamma-hydroxybutyrate (GHB) is an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of XYWAV are mediated through GABA B actions during sleep at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.

12.3Pharmacokinetics Pharmacokinetics of GHB are nonlinear and are similar following single or repeat dosing. The pharmacokinetics of oxybate following administration of XYWAV are similar between healthy subjects and patients with narcolepsy or patients with idiopathic hypersomnia. Absorption Following oral administration of XYWAV, the average time to peak plasma concentration (T max ) was about 1.3 hours in healthy adults in the fasted state.

Following oral administration of XYWAV, the plasma levels of GHB increased more than dose‑proportionally, with C max increasing approximately 2 ‐ fold and AUC increasing 2.9-fold as the dose was doubled from 2.25 g to 4.5 g. Effect of Food Administration of XYWAV immediately after a high-fat meal resulted in a mean reduction in C max of GHB by 33%, and mean reduction in systemic exposure (AUC) by 16% [see Dosage and Administration ( 2.4 )] . Distribution GHB has an apparent volume of distribution averaging 190 mL/kg to 384 mL/kg.

At GHB concentrations ranging from 3 mcg/mL to 300 mcg/mL. Less than 1% is bound to plasma proteins. Elimination Metabolism Animal studies indicate that metabolism is the major elimination pathway for GHB, producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle and secondarily by beta-oxidation.

The primary pathway involves a cytosolic NADP + -linked enzyme, GHB dehydrogenase, that catalyzes the conversion of GHB to succinic semialdehyde, which is then biotransformed to succinic acid by the enzyme succinic semialdehyde dehydrogenase. Succinic acid enters the Krebs cycle where it is metabolized to carbon dioxide and water. A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyzes the conversion to succinic semialdehyde in the presence of α-ketoglutarate.

An alternate pathway of biotransformation involves β-oxidation via 3,4-dihydroxybutyrate to carbon dioxide and water. No active metabolites have been identified. Excretion The clearance of GHB is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration.

On average, less than 5% of unchanged drug appears in human urine within 6 to 8 hours after dosing. Fecal excretion is negligible. GHB has a mean terminal elimination half-life of 0.66 hours.

Specific Populations Geriatric Patients There is limited experience with sodium oxybate and no experience with XYWAV in the elderly. Results from a pharmacokinetic study (n=20) in another studied population indicate that the pharmacokinetic characteristics of GHB are consistent among younger (ages 48 to 64 years) and older (ages 65 to 75 years) adults. Pediatric Patients The pharmacokinetics of XYWAV has not been directly evaluated in pediatric patients.

The pharmacokinetics of sodium oxybate was evaluated in pediatric patients aged 7 to 17 years and demonstrated similar PK properties as adults. A population pharmacokinetic model was developed with sodium oxybate data from pediatric and adult patients and healthy volunteers and with XYWAV data from healthy adult volunteers. The population PK model analyses demonstrate that body weight is the major intrinsic factor affecting GHB pharmacokinetics following sodium oxybate or XYWAV dosing.

Additionally, XYWAV has similar PK characteristics (more than dose proportionality) as sodium oxybate in pediatric patients, supporting the same dose regimen as sodium oxybate and…

🧬 Mechanism of Action 81 words ▾

12.1Mechanism of Action XYWAV is a CNS depressant. The exact mechanism of action of XYWAV in the treatment of narcolepsy and idiopathic hypersomnia is unknown. XYWAV is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (gamma-hydroxybutyrate).

Gamma-hydroxybutyrate (GHB) is an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of XYWAV are mediated through GABA B actions during sleep at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.

📦 How Supplied / Storage and Handling 162 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied XYWAV is a clear to slightly opalescent oral solution. Each prescription includes at least one bottle of XYWAV with attached press in bottle adaptor, an oral measuring device (plastic syringe), and a Medication Guide. The pharmacy provides two empty containers with child-resistant caps with each XYWAV shipment.

Each amber bottle contains XYWAV oral solution at a concentration of 0.5 g/mL and has a child-resistant cap. One 180 mL bottle: NDC 68727-150-01

16.2Storage Keep out of reach of children. XYWAV should be stored between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) (see USP Controlled Room Temperature). Dispense in tight containers. Solutions prepared following dilution should be consumed within 24 hours.

16.3Handling and Disposal XYWAV is a Schedule III drug under the Controlled Substances Act. XYWAV should be handled according to state and federal regulations. It is safe to dispose of XYWAV down the sanitary sewer.

📋 Description 171 words ▾

11 DESCRIPTION XYWAV oral solution contains oxybate, a CNS depressant. The chemical name of oxybate is gamma-hydroxybutyrate (GHB). XYWAV contains a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate equivalent to 0.5 g/mL, which corresponds to 0.413 g/mL oxybate.

Each mL of XYWAV contains: 0.234 g calcium oxybate, Ca(C 4 H 7 O 3 ) 2 ; 0.096 g magnesium oxybate, Mg(C 4 H 7 O 3 ) 2 ; 0.13 g potassium oxybate, K(C 4 H 7 O 3 ); and 0.04 g sodium oxybate, Na(C 4 H 7 O 3 ) in dissociated form in the solution. The molecular weights of each are as follows: calcium oxybate is 246.3, magnesium oxybate is 230.5, potassium oxybate is 142.2, and sodium oxybate is 126.1. The chemical structure is: y =1 for Na + and K + ; y =2 for Mg 2+ and Ca 2+ The inactive ingredients are purified water and sucralose.

XYWAV contains no ingredient made from a gluten‑containing grain (wheat, barley, or rye). chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Central Nervous System Depression Inform patients and/or caregivers that XYWAV can cause central nervous system depression, including respiratory depression, hypotension, profound sedation, syncope, and death. Instruct patients not to engage in activities requiring mental alertness or motor coordination, including operating hazardous machinery, for at least 6 hours after taking XYWAV.

Instruct patients and/or their caregivers to inform their healthcare providers of all the medications they take [see Warnings and Precautions ( 5.1 )]. Abuse and Misuse Inform patients and/or caregivers that the active ingredient of XYWAV is gamma-hydroxybutyrate (GHB), which is associated with serious adverse reactions with illicit use and abuse [see Warnings and Precautions ( 5.2 )]. XYWAV and XYREM REMS XYWAV is available only through a restricted program called the XYWAV and XYREM REMS [see Warnings and Precautions ( 5.3 )].

Inform the patient and/or caregiver of the following notable requirements: • XYWAV is dispensed only by the central pharmacy • XYWAV will be dispensed and shipped only to patients enrolled in the XYWAV and XYREM REMS XYWAV is available only from the central pharmacy participating in the program. Therefore, provide patients and/or caregivers with the telephone number and website for information on how to obtain the product. Alcohol or Sedative Hypnotics Advise patients and/or caregivers that alcohol and other sedative hypnotics should not be taken with XYWAV [see Contraindications ( 4 )] .

Sedation Inform patients and/or caregivers that the patient is likely to fall asleep quickly after taking XYWAV (often within 5 and usually within 15 minutes), but the time it takes to fall asleep can vary from night to night. The sudden onset of sleep, including in a standing position or while rising from bed, has led to falls complicated by injuries, in some cases requiring hospitalization [see Adverse Reactions ( 6.2 )] . Instruct patients and/or caregivers that the patient should remain in bed following ingestion of each dose.

Instruct patients and/or caregivers that the patient should not take a subsequent nightly dose until at least 2.5 to 4 hours after the previous dose [see Dosage and Administration ( 2.4 )] . Administration Instructions Inform patients to administer XYWAV at least 2 hours after eating. Inform patients and/or caregivers of patients taking XYWAV twice nightly, that the total nightly dosage of XYWAV is divided into two doses [see Dosage and Administration ( 2.4 )] .

Inform patients if their nightly dose requires multiple draws. Instruct patients on how to perform the draws from the bottle. Respiratory Depression and Sleep-Disordered Breathing Inform patients that XYWAV may impair respiratory drive, especially in patients with compromised respiratory function, and may cause apnea [see Warnings and Precautions ( 5.4 )] .

Depression and Suicidality Instruct patients and/or caregivers to contact a healthcare provider immediately if the patient develops depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or suicidal ideation [see Warnings and Precautions ( 5.5 )] . Other Behavioral or Psychiatric Adverse Reactions Inform patients and/or caregivers that XYWAV can cause behavioral or psychiatric adverse reactions, including confusion, anxiety, and psychosis.

Instruct them to notify their healthcare provider if any of these types of symptoms occur [see Warnings and Precautions ( 5.6 )]. Sleepwalking Instruct patients and/or caregivers that XYWAV has been associated with sleepwalking and other behaviors during sleep, and to contact their healthcare provider if this…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE XYWAV ® (ZYE wave) (calcium, magnesium, potassium, and sodium oxybates) oral solution, CIII Read this Medication Guide carefully before you start or your child starts taking XYWAV, and each time you get or your child gets a refill. There may be new information. This information does not take the place of talking to your doctor about your or your child’s medical condition or treatment.

What is the most important information I should know about XYWAV? • XYWAV is a central nervous system (CNS) depressant. Taking XYWAV with other CNS depressants, such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including: o trouble breathing (respiratory depression) o low blood pressure (hypotension) o changes in alertness (drowsiness) o fainting (syncope) o death Ask your doctor if you are not sure if you are, or your child is, taking a medicine listed above. • XYWAV is a federal controlled substance (CIII).

The active ingredient of XYWAV is a form of gamma-hydroxybutyrate (GHB) that is also a federal controlled substance (CI). Abuse of illegal GHB, either alone or with other CNS depressants, may cause serious medical problems, including: o seizure o trouble breathing (respiratory depression) o changes in alertness (drowsiness) o coma o death Call your doctor right away if you have or your child has any of these serious side effects. • Anyone who takes XYWAV should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYWAV.

Those activities should not be done until you know how XYWAV affects you or your child. • Keep XYWAV in a safe place to prevent abuse and misuse. Selling or giving away XYWAV may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Because of the risk of CNS depression, abuse, and misuse, XYWAV is available only by prescription, and filled through the central pharmacy in the XYWAV and XYREM REMS.

You or your child must be enrolled in the XYWAV and XYREM REMS to receive XYWAV. For information on how to receive XYWAV, visit www.XYWAVXYREMREMS.com . Before you receive or your child receives XYWAV, your doctor or pharmacist will make sure that you understand how to take XYWAV safely and effectively.

If you have any questions about XYWAV, ask your doctor or call the XYWAV and XYREM REMS at 1-866-997-3688. What is XYWAV? XYWAV is a prescription medicine used to treat: • the following symptoms in people 7 years of age or older with narcolepsy: o sudden onset of weak or paralyzed muscles (cataplexy), or o excessive daytime sleepiness (EDS) • idiopathic hypersomnia (IH) in adults It is not known if XYWAV is safe and effective in children less than 7 years of age with narcolepsy.

It is not known if XYWAV is safe and effective in children with IH. Do not take XYWAV if you or your child: • takes other sleep medicines or sedatives (medicines that cause sleepiness) • drinks alcohol • has a rare problem called succinic semialdehyde dehydrogenase deficiency Before taking XYWAV, tell your doctor about all medical conditions, including if you or your child: • have a history of drug abuse. • have short periods of not breathing while sleeping (sleep apnea). • has trouble breathing or has lung problems.

You or your child may have a higher chance of having serious breathing problems when taking XYWAV. • have or had depression or has tried to harm yourself or themselves. You or your child should be watched carefully for new symptoms of depression. • has or had behavior or other psychiatric problems such as: o anxiety o feeling more suspicious (paranoia) o acting aggressive o seeing or…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68727-0100-01 · Jazz 68727-0250-01 · Jazz →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.