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Edluar Zolpidem Tartrate 5 mg Tablet, 30-count — NDC 00037-6050-30 package photo

Edluar Zolpidem Tartrate 5 mg Tablet, 30-count

by Viatris Specialty LLC · 3 BLISTER PACK in 1 CARTON (0037-6050-30) / 10 TABLET in 1 BLISTER PACK
NDC 00037-6050-30
🏷️ FDA NDC (as labeled) 0037-6050-30 billing pads the labeler segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also comes in: 30 tablets 00037-6050-93
Rx only Brand On market CIV
🗂️ Data synced Jul 24, 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) 0037-6050-30
Product NDC 0037-6050
11-digit billing NDC 00037605030
NCPDP billing unit EA — each (per item)
RxCUI 836641, 836645, 836647, 836649
UNII WY6W63843K
Application # NDA021997
SPL Set ID a32884d0-85b5-11de-8a39-0800200c9a66
Established class (EPC) gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of action GABA A Receptor Positive Modulators
Physiologic effect Central Nervous System Depression
DEA schedule CIV
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-07-24
Route ORAL
Dosage form TABLET
Substance ZOLPIDEM TARTRATE
GPI-14 60204080100720
GPI class Edluar
GCN Seq No 065335
GCN 26183
HICL code 007842
Ingredient (HICL) Zolpidem Tartrate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 28:24.44.00
AHFS class Non-Benzodiazepine Hypnotics
FDB label name EDLUAR 5 MG SL TABLET
FDB brand name Edluar
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0037-6050-30 — a 4-4-2 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 labeler segment → 00037-6050-30. 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 gamma-Aminobutyric Acid A Receptor Positive Modulator class.

Pharmacologic class gamma-Aminobutyric Acid A Receptor Positive Modulator
Drug family (ATC) Benzodiazepine related drugs
How it works GABA A Receptor Positive Modulators
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

LabelerViatris Specialty LLC
Application holderVIATRIS SPECIALTY LLC
FDA applicationNDA021997 (NDA)
Labeler code00037
First marketedJul 2009
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio120 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 EDLUAR 5 MG SL TABLET Ingredient Zolpidem Tartrate
📗 Our plain-language guide HelloPharmacist
  • Zolpidem is a prescription sleep medicine for insomnia. Depending on which form your doctor prescribed, it can help you fall asleep faster at bedtime, sleep through the night witho...
  • What exactly is zolpidem supposed to do for me?
  • This is one of the most important things to know: zolpidem can impair your driving and mental sharpness the next morning, even if you feel wide awake and fine. The risk goes up if...
  • Is it safe to drive to work the morning after taking zolpidem?
📖 Read our full Zolpidem guide →
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.

💊 What it looks like

Color White
ShapeRound
ImprintX
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets
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
Zolpidem 5 mg 71093-0155-04 ACI 100 tablets $0.035 AB Availability likely —
Zolpidem Tartrate 5 mg 00904-6082-61 Major 100 tablets $0.035 AB Availability likely —
Zolpidem Tartrate 5 mg 60687-0838-01 American 1 tablet $0.035 AB Availability likely —
Zolpidem Tartrate 5 mg 00781-5317-01 Sandoz 100 tablets $0.035 AB Availability likely —
Zolpidem Tartrate 5 mg 16714-0621-01 NorthStar 100 tablets $0.035 AB Availability likely —
Zolpidem Tartrate 5 mg 62135-0778-90 Chartwell 90 tablets $0.035 AB Availability likely —
Zolpidem Tartrate 5 mg 13668-0007-01 Torrent 100 tablets $0.035 AB Availability likely —
Zolpidem Tartrate 5 mg 65862-0159-01 Aurobindo 100 tablets $0.035 AB Availability likely —
Ambien 5 mg 00713-5401-01 Cosette 100 tablets $20.620 AB FDA listed —
Ambien 5 mg 00024-5401-31 Sanofi-Aventis 100 tablets $20.620 AB FDA listed —
Edluar 5 mgthis 00037-6050-30 Viatris 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 63187-0558-05 Proficient 5 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 63187-0707-15 Proficient 15 tablets — — FDA listed —
Zolpidem Tartrate 5 mg 71610-0151-15 Aphena 15 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 71610-0156-30 Aphena 30 tablets — AB FDA listed —
Zolpidem 5 mg 71610-0670-30 Aphena 30 tablets — AB FDA listed —
Zolpidem 5 mg 72162-1982-01 Bryant 100 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 80425-0087-01 Advanced 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 80425-0165-01 Advanced 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 50090-7434-00 A-S 90 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 61919-0751-10 Direct_Rx 10 tablets — AB FDA listed —
Zolpidem 5 mg 63629-1170-01 Bryant 100 tablets — AB Discontinued —
Zolpidem Tartrate 5 mg 76420-0233-30 Asclemed 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 80425-0322-01 Advanced 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 63187-0691-15 Proficient 15 tablets — AB FDA listed —
Zolpidem 5 mg 71610-0847-10 Aphena 10 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 72789-0390-21 PD-Rx 21 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 50090-3879-00 A-S 20 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 68071-4598-03 NuCare 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 76420-0416-00 Asclemed 1000 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 63629-3549-00 Bryant 25 tablets — AB FDA listed —
Zolpidem 5 mg 63629-9613-01 Bryant 1000 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 70518-2917-00 REMEDYREPACK 60 tablets — AB Discontinued —
Zolpidem Tartrate 5 mg 72722-0103-01 The 30 tablets — AB FDA listed —
Zolpidem 5 mg 80425-0430-01 Advanced 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 50090-1022-00 A-S 20 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 68788-8854-03 Preferred 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 80425-0513-01 Advanced 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 60760-0761-30 ST. 30 tablets — AB FDA listed —
Zolpidem 5 mg 63629-8998-01 Bryant 30 tablets — AB FDA listed —
Zolpidem 5 mg 51407-0877-01 Golden 100 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 55154-1398-00 Cardinal 10 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 50090-2649-00 A-S 20 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 55700-0268-30 Quality 30 tablets — AB Discontinued —
Zolpidem Tartrate 5 mg 68071-2232-04 NuCare 14 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 68788-9126-02 Preferred 28 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 71335-9629-00 Bryant 25 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 51407-0941-01 Golden 100 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 60760-0515-30 St. 30 tablets — AB FDA listed —
Zolpidem Tartrate 5 mg 68071-3482-02 NuCare 2 tablets — AB Discontinued —
Zolpidem Tartrate 5 mg 71610-0904-10 Aphena 10 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2009
First FDA approval
Mar 2009
📍
2026
Currently FDA-listed
17 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 13, 2009 AB TE-rated RLD RS ⏳ ~4.4 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 9265720 — method of use (U-674)
US 9265720 — method of use (U-674)
US 9597281 — method of use (U-674)
US 9597281 — method of use (U-674)
2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
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 (4)
PatentTypeUse codeExpires
US 9265720 ↗ Method of use U-674 Feb 25, 2031
US 9265720 ↗ Method of use U-674 Feb 25, 2031
US 9597281 ↗ Method of use U-674 Apr 6, 2027
US 9597281 ↗ Method of use U-674 Apr 6, 2027
Common questions
Is there a generic version of EDLUAR 5 MG SL TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for EDLUAR 5 MG SL TABLET. See the alternatives section for substitutable, lower-cost products.
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.

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

Medicare Part D (outpatient prescription) spending for Edluar — 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 Edluar. 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
$244.4K
Claims incl. refills
425
Beneficiaries
214
Spend / beneficiary
$1,141.89
Spend / claim
$574.97
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00037-6050-30 You're viewing this 3 BLISTER PACK in 1 CARTON (0037-6050-30) / 10 TABLET in 1 BLISTER PACK 2009-07-24 Active
00037-6050-93 5 BLISTER PACK in 1 CARTON (0037-6050-93) / 6 TABLET in 1 BLISTER PACK (0037-6050-35) 2022-02-16 Active

Pack size FAQ

What quantity is in NDC 00037-6050-30?
NDC 00037-6050-30 is a 30-count package — 3 blister pack in 1 carton / 10 tablet in 1 blister pack.
What is the difference between NDC 00037-6050-30 and NDC 00037-6050-93?
Both are Edluar Zolpidem Tartrate 5 mg Tablet — the drug itself is identical. NDC 00037-6050-30 is the 30-count package, while NDC 00037-6050-93 is the 30 tablets package.
What NDC number is used to bill for this package of Edluar Zolpidem Tartrate 5 mg Tablet?
Bill NDC 00037-6050-30 — the 11-digit billing format is 00037605030. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
Inactive ingredients (structured) ✓ 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 0037-6050-30, 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: 00037-6050-30, written without dashes as 00037605030. 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 00037-6050-30, the first segment (00037) is the labeler code FDA assigned to Viatris Specialty LLC; the middle segment (6050) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Viatris Specialty LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (00037-6050-93). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Viatris Specialty LLC 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 116 words ▾

WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ].

WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Edluar. Some of these events may result in serious injuries, including death.

Discontinue Edluar immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )

🎯 Indications and Usage 103 words ▾

1 INDICATIONS AND USAGE Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ] . The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Edluar, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Use the lowest dose effective for the patient ( 2.1 ) • Recommended dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime. ( 2.1 ) • Geriatric patients and patients with hepatic impairment: Recommended dose is 5 mg for men and women. ( 2.2 ) • Lower doses of CNS depressants may be necessary when taken concomitantly with Edluar.

( 2.3 ) • Co-administration with CNS depressants: Recommended dose is 5 mg for men and women. ( 2.3 ) • The effect of Edluar may be slowed if taken with or immediately after a meal. ( 2.4 ) • Edluar sublingual tablet should be placed under the tongue, where it will disintegrate.

( 2.4 ) • The tablet should not be swallowed and the tablet should not be taken with water. ( 2.4 )

2.1Dosage in Adults Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg.

In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1) ] . The total dose of Edluar should not exceed 10 mg once daily immediately before bedtime. The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

2.2Special Populations Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Edluar in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1) ; Use in Specific Populations (8.5) ] .

2.3Use with CNS Depressants Dosage adjustment may be necessary when Edluar is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1) ] .

2.4Administration The effect of Edluar may be slowed by ingestion with or immediately after a meal. Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.

💊 Dosage Forms and Strengths 68 words ▾

3 DOSAGE FORMS AND STRENGTHS Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. Tablets are not scored. Edluar 5 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed V on one side. Edluar 10 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed X on one side. Sublingual tablets: 5 mg and 10 mg. Tablets not scored. ( 3 )

⛔ Contraindications 66 words ▾

4 CONTRAINDICATIONS Edluar is contraindicated in patients: • who have experienced complex sleep behaviors after taking Edluar [see Warnings and Precautions (5.1) ]. • with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4) ] . • Patients who have experienced complex sleep behaviors after taking Edluar. ( 4 , 5.1 ) • Known hypersensitivity to zolpidem. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • CNS Depressant Effects: Impairs alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Instruct patients on correct use.

( 5.2 ) • Need to Evaluate for Co-morbid Diagnosis: Reevaluate if insomnia persists after 7 to 10 days of use. ( 5.3 ) • Severe Anaphylactic and Anaphylactoid Reactions: angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.

( 5.4 ) • Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation and depersonalization have been reported. Immediately evaluate any new onset behavioral changes. ( 5.5 ) • Depression: Worsening of depression or suicidal thinking may occur.

Prescribe the least amount of tablets feasible to avoid intentional overdose. ( 5.6 ) • Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function. ( 5.7 ) • Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation.

( 5.8 , 9.3 )

5.1Complex Sleep Behaviors Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome.

Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Post-marketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interactions (7.1) ] .

Discontinue Edluar immediately if a patient experiences a complex sleep behavior .

5.2CNS Depressant Effects and Next-Day Impairment Edluar, like other sedative-hypnotic drugs, CNS depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of Edluar and of other concomitant CNS depressants may be necessary when Edluar is administered with such agents because of the potentially additive effects.

The use of Edluar with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Dosage and Administration (2.3) ] . The risk of next-day psychomotor impairment, including impaired driving, is increased if Edluar is taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if co-administered with other CNS depressants; or if co-administered with other drugs that increase the blood level of zolpidem.

Patients should be cautioned against driving and other activities requiring complete mental alertness if Edluar is taken in these circumstances. Because Edluar can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.

5.3Need to Evaluate for Co-morbid Diagnoses Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder.

Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.

5.4Severe Anaphylactic and Anaphylactoid Reactions Cases of angioedema involving the tongue, glottis or larynx have been reported in pat…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Complex Sleep Behaviors [see Warnings and Precautions (5.1) ] • CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2) ] • Serious Anaphylactic and Anaphylactoid Reactions [see Warning and Precautions (5.4) ] • Abnormal Thinking and Behavioral Changes [see Warning and Precautions (5.5) ] • Withdrawal Effects [see Warning and Precautions (5.8) ] Most commonly observed adverse reactions were: Short term (< 10 nights): Drowsiness, dizziness, and diarrhea Long term (28-35 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-444-7799 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Associated with discontinuation of treatment: Approximately 4% of 1,701 patients who received zolpidem tartrate at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%). Approximately 4% of 1,959 patients who received zolpidem tartrate at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction.

Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%). Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem tartrate revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.

Most commonly observed adverse reactions in controlled trials: During short-term treatment (up to 10 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).

Adverse reactions observed at an incidence of ≥1% in controlled trials: The following tables enumerate treatment-emergent adverse event frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

The following table was derived from a pool of…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • CNS-depressants, including alcohol: Possible adverse additive CNS-depressant effects ( 5.1 , 7.1 ) • Imipramine: decreased alertness observed ( 7.1 ) • Chlorpromazine: impaired alertness and psychomotor performance observed ( 7.1 ) • Rifampin: combination use may decrease effects ( 7.2 ) • Ketoconazole: combination use may increase effect ( 7.2 )

7.1CNS-active Drugs CNS Depressants Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.1 , 5.2) ] . Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine, Chlorpromazine Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness.

Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance [see Clinical Pharmacology (12.3) ] . Haloperidol A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration [see Clinical Pharmacology (12.3) ] .

Alcohol An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions (5.1) ] . Sertraline Concomitant administration of zolpidem and sertraline increases exposure to zolpidem and may increase the pharmacodynamics effect of zolpidem [see Clinical Pharmacology (12.3) ] . Fluoxetine After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed.

There was no evidence of an additive effect in psychomotor performance [see Clinical Pharmacology (12.3) ] .

7.2Drugs That Affect Drug Metabolism Via Cytochrome P450 Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of other P450 enzymes on the exposure to zolpidem is not known. Rifampin Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamics effects of zolpidem.

Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem. Ketoconazole Ketoconazole, a potent CYP3A4 inhibitor, increased the pharmacodynamics effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together.

Drug Interactions CNS-depressants: Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.1) ] . Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness.

Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration.

An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions (5.1) ] . Following five consecutive nightly doses at bedtime of oral zolpidem tartrate 10 mg in the presence of sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem C max was significantly higher (43%) and T max was significantly decreased (-53%). P…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in third trimester. ( 8.1 ) • Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after Edluar administration. ( 8.2 ) • Pediatric use: Safety and effectiveness not established.

Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder. ( 5.4 , 8.4 )

8.1Pregnancy Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation ( see Clinical Considerations and Data ) . Published data on the use of zolpidem during pregnancy have not identified a drug-associated risk of and major birth defects ( see Data ). Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Fetal/neonatal adverse reactions Zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to Edluar during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. Data Human Data Published data from observational studies, birth registries and case reports on the use of zolpidem during pregnancy have not identified a drug-associated risk of major birth defects.

There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. These cases required artificial ventilation or intra-tracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated.

Zolpidem has been shown to cross the placenta. Animal Data Oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times the MRHD based on mg/m 2 body surface area. Oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16 mg base/kg/day, which are approximately 2.5, 10, and 40 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times the MRHD based on mg/m 2 body surface area.

Oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, delayed offspring growth and decreased survival at doses 25 and 120 times, respectively, the MRHD based on mg/m 2 body surface area.

8.2Lactation Risk Summary Limited data from published literature reports the presence of zolpidem in human milk. There are reports of excess sedation in infants exposed to zolpidem through breastmilk ( see Clinical Considerations ). There is no information on the effects of zolpidem on milk production. The developmental and health benefits of breastfeeding should be c…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation ( see Clinical Considerations and Data ) . Published data on the use of zolpidem during pregnancy have not identified a drug-associated risk of and major birth defects ( see Data ). Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Fetal/neonatal adverse reactions Zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to Edluar during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. Data Human Data Published data from observational studies, birth registries and case reports on the use of zolpidem during pregnancy have not identified a drug-associated risk of major birth defects.

There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. These cases required artificial ventilation or intra-tracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated.

Zolpidem has been shown to cross the placenta. Animal Data Oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times the MRHD based on mg/m 2 body surface area. Oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16 mg base/kg/day, which are approximately 2.5, 10, and 40 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times the MRHD based on mg/m 2 body surface area.

Oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, delayed offspring growth and decreased survival at doses 25 and 120 times, respectively, the MRHD based on mg/m 2 body surface area.

🧒 Pediatric Use 137 words ▾

8.4Pediatric Use Edluar is not recommended for use in children. Safety and effectiveness in pediatric patients have not been established in pediatric patients below the age of 18. In an 8-week controlled study in 201 pediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD), an oral solution of zolpidem tartrate dosed at 0.25mg/kg at bedtime did not decrease sleep latency compared to placebo.

Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction. Psychiatric and nervous system disorders comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs.

9.2%), and hallucinations reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Warnings and Precautions (5.4) ] .

🧓 Geriatric Use 203 words ▾

8.5Geriatric Use A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received oral zolpidem were ≥60 years of age. For a pool of U.S. patients receiving zolpidem tartrate at doses of ≤10 mg or placebo, there were three adverse events occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug-related). Adverse Event Zolpidem Placebo Dizziness 3% 0% Drowsiness 5% 2% Diarrhea 3% 1% A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem tartrate reported falls, including 28/30 (93%) who were ≥70 years of age.

Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg.

The dose of Edluar in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Dosage and Administration (2) , Warnings and Precautions (5) Clinical Pharmacology (12) and Clinical Studies (14) ] .

🆘 Overdosage 219 words ▾

10 OVERDOSAGE

10.1Signs and Symptoms In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.

10.2Recommended Treatment Based on data obtained for zolpidem tartrate, general symptomatic and supportive measures for overdose with Edluar should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem’s sedative/hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions).

As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs.

The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α 1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

12.2Pharmacodynamics Zolpidem binds to GABA A receptors with a greater affinity for α 1 subunit relative to α 2 and α 3 subunit containing receptors. Zolpidem has no appreciable binding affinity for α 5 subunit containing GABA A receptors. This binding profile may explain the relative absence of myorelaxant effects in animal studies.

Zolpidem has no appreciable binding affinity for dopaminergic D2, serotonergic 5HT 2 , adrenergic, histaminergic or muscarinic receptors.

12.3Pharmacokinetics Absorption: Edluar (zolpidem tartrate) sublingual tablets are bioequivalent to Ambien ® tablets (Sanofi-Aventis) with respect to C max and AUC. Similar to zolpidem tartrate oral tablets, Edluar sublingual tablets result in a pharmacokinetic profile characterized by rapid absorption. Following administration of single 10 mg Edluar, in 18 healthy adult subjects (18-65 years of age), the mean peak concentration (C max ) of zolpidem was 106 ng/mL (range: 52 to 205 ng/ml) occurring at a median time (T max ) of 82 minutes (range: 30-180 min).

A food-effect study in 18 healthy volunteers compared the pharmacokinetics of Edluar 10 mg when administered while fasting or within 20 minutes after a high fat meal. The mean AUC and C max were decreased by 20% and 31%, respectively, while median T max was prolonged by 28% (from 82 to 105 min). The half-life remained unchanged.

These results suggest that, for faster sleep onset, Edluar should not be administered with or immediately after a meal. Distribution: Based on data obtained with oral zolpidem, the total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL. Metabolism: Based on data obtained with oral zolpidem, zolpidem is converted to inactive metabolites that are eliminated primarily by renal excretion.

Elimination: When Edluar administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem elimination half-life was 2.85 hours (range: 1.57-6.73 hr) and 2.65 hours (range: 1.75 to 3.77 hr) respectively. Special Populations Elderly: In the elderly, the dose for Edluar should be 5 mg [see Warnings and Precautions (5) and Dosage and Administration (2) ] . This recommendation is based on several studies with zolpidem tartrate in which the mean C max , T 1/2 , and AUC were significantly increased when compared to results in young adults.

In one study of eight elderly subjects (>70 years), the means for C max , T 1/2 , and AUC significantly increased by 50% (255 vs. 384 ng/mL), 32% (2.2 vs. 2.9 hr), and 64% (955 vs.

1,562 ng•hr/mL), respectively, as compared to younger adults (20 to 40 years) following a single 20 mg oral dose. Zolpidem did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week. Hepatic Impairment: The pharmacokinetics of zolpidem tartrate in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects.

Following a single 20-mg oral zolpidem tartrate dose, mean C max and AUC were found to be two times (250 vs. 499 ng/mL) and five times (788 vs. 4,203 ng•hr/mL) higher, respectively, in hepatically-compromised patients.

T max did not change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normals of 2.2 hr (range: 1.6 to 2.4 hr). Dosing with Edluar should be modified accordingly in patients with hepatic insufficiency [see Dosage and Administration (2.2) ] .

Renal Impairment: The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage 4 renal failure (mean Cl Cr = 6.5 ± 1.5 mL/min) undergoi…

🧬 Mechanism of Action 52 words ▾

12.1Mechanism of Action Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α 1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

📦 How Supplied / Storage and Handling 135 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Edluar is supplied as sublingual tablets in two dosage strengths: Tablets are not scored. Edluar 5 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed V on one side and supplied as: NDC Number Size 0037-6050-30 carton of 30 tablets (3 x 10 tablets) 0037-6050-93 carton of 30 tablets (5 x 6 tablets) The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters. Edluar 10 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed X on one side and supplied as: NDC Number Size 0037-6010-30 carton of 30 tablets (3 x 10 tablets) 0037-6010-93 carton of 30 tablets (5 x 6 tablets) The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters.

Store at controlled room temperature 20-25°C (68-77°F). Protect from light and moisture.

📋 Description 100 words ▾

11 DESCRIPTION Edluar contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. Chemically, zolpidem tartrate is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1).

It has the following structure: Zolpidem tartrate, USP is a white to almost white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Edluar tablet includes the following inactive ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.

Chemical Structure of zolpidem tartrate

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Medication Guide ) . Inform patients and their families about the benefits and risks of treatment with Edluar. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with Edluar and with each prescription refill.

Review the Edluar Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that Edluar should be taken only as prescribed. Complex Sleep Behaviors Instruct patients and their families that Edluar may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake.

Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue Edluar and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning , Warnings and Precautions (5.1) ] . CNS-depressant Effects and Next-Day Impairment Tell patients that Edluar has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed.

Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Warnings and Precautions (5.2) ] .

Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Warnings and Precautions (5.4) ] . Suicide Tell patients to immediately report any suicidal thoughts.

Alcohol and Other Drugs Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use Edluar if they drank alcohol that evening or before bed. Tolerance, Abuse, and Dependence Tell patients not to increase the dose of Edluar on their own, and to inform you if they believe the drug “does not work”.

Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Edluar. Advise patients that use of Edluar late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used Edluar during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness [see Use in Specific Populations (8.1) ].

Lactation Advise breastfeeding mothers using Edluar to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after Edluar administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations (8.2) ].

Administration Instructions Patients should be counseled to take Edluar right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Edluar tablets should not be taken with or immediately after a meal. Advise patients NOT to take Edluar when drinking alcohol that evening or before bed.

Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.

💬 Medication Guide ~3 min read ▾

Medication Guide Edluar ® [ED’ – loo-ahr] (zolpidem tartrate) sublingual tablets C-IV Read this Medication Guide that comes with Edluar before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Edluar? • Do not take more Edluar than prescribed. • Do not take Edluar unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again. • Take Edluar right before you get in bed, not sooner. Edluar may cause serious side effects, including: • Complex sleep behaviors that have caused serious injury and death. After taking Edluar, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors).

The next morning, you may not remember that you did anything during the night. These activities may occur with Edluar whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities include: o driving a car (“sleep-driving”) o making and eating food o talking on the phone o having sex o sleep-walking Stop taking Edluar and call your healthcare provider right away if you find out that you have done any of the above activities after taking Edluar.

Do not take Edluar if you: • have ever experienced a complex sleep behavior (such as driving a car, making or eating food, talking on the phone, or having sex) while not being fully awake after taking Edluar • drank alcohol that evening or before bed • took another medicine to help you sleep What is Edluar? Edluar is a sedative-hypnotic (sleep) medicine. Edluar is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

It is not known if Edluar is safe and effective in children under the age of 18 years. Edluar is a class four (C-IV) federally controlled substance because it can be abused or lead to dependence. Keep Edluar in a safe place to prevent misuse and abuse.

Selling or giving away Edluar 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. Who should not take Edluar? • Do not take Edluar if you are allergic to zolpidem or any other ingredients in Edluar.

See the end of this Medication Guide for a complete list of ingredients in Edluar. • Do not take Edluar if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Zolpimist, or Intermezzo. Symptoms of a serious allergic reaction to zolpidem can include: • swelling of your face, lips, and throat that may cause difficulty breathing or swallowing • nausea and vomiting What should I tell my healthcare provider before taking Edluar? Edluar may not be right for you.

Before starting Edluar, tell your healthcare provider about all of your health conditions, including if you: • have a history of depression, mental illness or, suicidal thoughts • have a history of drug or alcohol abuse or addiction • have kidney or liver disease • have lung disease or breathing problems • are pregnant or planning to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take Edluar. • using Edluar in the last trimester of pregnancy may cause breathing difficulties or excess sleepiness in your newborn.

Monitor for signs of sleepiness (more than usual), trouble breathing, or limpness in the newborn if Edluar is taken late in pregnancy. • are breastfeeding or plan to breastfeed. Edluar passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take Edluar.

Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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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.