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Hetlioz tasimelteon 20 mg Capsule, 30-count — NDC 43068-0220-01 package photo

Hetlioz tasimelteon 20 mg Capsule, 30-count

by Vanda Pharmaceuticals Inc. · 30 CAPSULE in 1 BOTTLE (43068-220-01)
NDC 43068-0220-01
🏷️ FDA NDC (as labeled) 43068-220-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 20, 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) 43068-220-01
Product NDC 43068-220
11-digit billing NDC 43068022001
NCPDP billing unit EA — each (per item)
RxCUI 1490473, 1491624, 2468312, 2468316
UNII SHS4PU80D9
Application # NDA205677
SPL Set ID ca4a9b63-708e-49e9-8f9b-010625443b90
Established class (EPC) Melatonin Receptor Agonist
Mechanism of action Melatonin Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-04-04
Route ORAL
Dosage form CAPSULE
Substance TASIMELTEON
GCN Seq No 072007
GCN 36068
HICL code 040927
Ingredient (HICL) Tasimelteon
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H8
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 2)
HIC3 code H8B
Therapeutic class — specific (HIC3) Hypnotics, Melatonin Mt1/Mt2 Receptor Agonists
AHFS code 28:24.48.00
AHFS class Melatonin Receptor Agonists
FDB label name HETLIOZ 20 MG CAPSULE
FDB brand name Hetlioz
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 43068-220-01 — 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 → 43068-0220-01. 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 Melatonin Receptor Agonist class.

Pharmacologic class Melatonin Receptor Agonist
Drug family (ATC) Melatonin receptor agonists
How it works Melatonin Receptor Agonists
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

LabelerVanda Pharmaceuticals Inc.
Application holderVANDA PHARMACEUTICALS INC
FDA applicationNDA205677 (NDA)
Labeler code43068
First marketedApr 2014
Product typeHuman Prescription Drug
Portfolio38 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 HETLIOZ 20 MG CAPSULE Ingredient Tasimelteon
📖 What it is MedlinePlus · NLM

Tasimelteon is used to treat non-24-hour sleep-wake disorder (non-24; a condition that occurs mainly in people who are blind in which the body's natural clock is out of sync with the normal day-night cycle and causes a disrupted sleep schedule) in adults. It is also used to treat nighttime sleep problems in adults and children 3 years of age and older with Smith-Magenis Syndrome (SMS; a developmental disorder). Tasimelteon is in a class of medications called melatonin receptor agonists. It works similarly to melatonin, a natural substance in the brain that is needed for sleep.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • That's a really common question, and the honest answer is: it varies. Because everyone's internal body clock runs a little differently, some people notice improvement within a few...
  • How long will it take before I actually start sleeping better?
  • You'll want to time your meal carefully. Eating — especially a high-fat meal — can significantly reduce how much tasimelteon your body actually absorbs, and it delays how quickly t...
  • Drowsiness is a known effect of tasimelteon, which is actually intentional — it's helping shift your sleep timing. The main advice is to take it and then head straight to bed; don'...
📖 Read our full Tasimelteon 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 Blue / White
ShapeCapsule
ImprintVANDA;20;mg
Size19 mm
ScoringNot scored
FlavorCherry
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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 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 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 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.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 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 $721.34 $21,640.22 / 30 capsules
Medicare drug plans payPart D · Q2 2026 $869.39 $26,081.58 / 30 capsules
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
Tasimelteon 20 mg 00480-4490-56 Teva 30 capsules $271.221 AB Availability likely —
Tasimelteon 20 mg 60505-4665-03 Apotex 30 capsules $271.221 AB Availability likely —
Tasimelteon 20 mg 69238-2548-03 Amneal 30 capsules $271.221 AB Availability likely —
Hetlioz 20 mgthis 43068-0220-01 Vanda 30 capsules — 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

🏛️
2014
First FDA approval
Jan 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2041
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 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 31, 2014 AB TE-rated 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 9539234 — method of use (U-1934)
US 9855241 — method of use (U-2149)
US RE46604 — method of use (U-2147)
US 10149829 — method of use (U-2477)
US 9730910 — method of use (U-2085)
US 9060995 — method of use (U-1710)
US 10449176 — method of use (U-2149)
US 10376487 — method of use (U-2615)
US 11141400 — method of use (U-2615)
US 11141400 — method of use (U-3007)
US 10945988 — method of use (U-2149)
US 11266622 — method of use (U-3003)
US 11633377 — method of use (U-2149)
US 11633377 — method of use (U-3003)
US 9730910 — method of use (U-3005)
US 9539234 — method of use (U-3004)
US 10376487 — method of use (U-3007)
US 10149829 — method of use (U-3006)
US 10610510 — method of use (U-3009)
US 10610511 — method of use (U-3007)
US 10610511 — method of use (U-2615)
US 10179119 — method of use (U-3003)
US 12201604 — method of use (U-3003)
US 12201604 — method of use (U-3865)
US 11759446 — method of use (U-3003)
US 11786502 — method of use (U-3007)
US 11786502 — method of use (U-3739)
US 10610510 — method of use (U-2805)
US 10980770 — method of use (U-3106)
US 10980770 — method of use (U-3107)
US 11850229 — method of use (U-3342)
US 11850229 — method of use (U-3343)
US 11833130 — method of use (U-2149)
US 11833130 — method of use (U-3003)
US 11918557 — method of use (U-3003)
US 11918557 — method of use (U-3865)
US 11918556 — method of use (U-3342)
US 11918556 — method of use (U-3343)
US 11826339 — method of use (U-3342)
US 11826339 — method of use (U-3343)
US 11285129 — method of use (U-3342)
US 11285129 — method of use (U-3343)
US 9549913 — method of use (U-1486)
US 11566011 — drug substance
US 12049457 — drug substance
US 10829465 — drug substance
US 11760740 — drug substance
US 10071977 — drug substance
Exclusivity ODE-330
2014 2016 2018 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 (48)
PatentTypeUse codeExpires
US 9539234 ↗ Method of use U-1934 Jan 25, 2033
US 9855241 ↗ Method of use U-2149 Jan 25, 2033
US RE46604 ↗ Method of use U-2147 Jan 25, 2033
US 10149829 ↗ Method of use U-2477 Jan 25, 2033
US 9730910 ↗ Method of use U-2085 May 17, 2034
US 9060995 ↗ Method of use U-1710 Jan 25, 2033
US 10449176 ↗ Method of use U-2149 Jan 25, 2033
US 10376487 ↗ Method of use U-2615 Jul 27, 2035
US 11141400 ↗ Method of use U-2615 Oct 10, 2034
US 11141400 ↗ Method of use U-3007 Oct 10, 2034
US 10945988 ↗ Method of use U-2149 Jan 25, 2033
US 11266622 ↗ Method of use U-3003 Aug 29, 2035
US 11633377 ↗ Method of use U-2149 Jan 25, 2033
US 11633377 ↗ Method of use U-3003 Jan 25, 2033
US 9730910 ↗ Method of use U-3005 May 17, 2034
US 9539234 ↗ Method of use U-3004 Jan 25, 2033
US 10376487 ↗ Method of use U-3007 Jul 27, 2035
US 10149829 ↗ Method of use U-3006 Jan 25, 2033
US 10610510 ↗ Method of use U-3009 Jan 25, 2033
US 10610511 ↗ Method of use U-3007 Oct 10, 2034
US 10610511 ↗ Method of use U-2615 Oct 10, 2034
US 10179119 ↗ Method of use U-3003 Aug 29, 2035
US 12201604 ↗ Method of use U-3003 Jan 25, 2033
US 12201604 ↗ Method of use U-3865 Jan 25, 2033
US 11759446 ↗ Method of use U-3003 Feb 21, 2041
US 11786502 ↗ Method of use U-3007 Oct 10, 2034
US 11786502 ↗ Method of use U-3739 Oct 10, 2034
US 10610510 ↗ Method of use U-2805 Jan 25, 2033
US 10980770 ↗ Method of use U-3106 Jan 25, 2033
US 10980770 ↗ Method of use U-3107 Jan 25, 2033
US 11850229 ↗ Method of use U-3342 Jan 25, 2033
US 11850229 ↗ Method of use U-3343 Jan 25, 2033
US 11833130 ↗ Method of use U-2149 Jan 25, 2033
US 11833130 ↗ Method of use U-3003 Jan 25, 2033
US 11918557 ↗ Method of use U-3003 Jan 25, 2033
US 11918557 ↗ Method of use U-3865 Jan 25, 2033
US 11918556 ↗ Method of use U-3342 Apr 7, 2033
US 11918556 ↗ Method of use U-3343 Apr 7, 2033
US 11826339 ↗ Method of use U-3342 Jan 25, 2033
US 11826339 ↗ Method of use U-3343 Jan 25, 2033
US 11285129 ↗ Method of use U-3342 Jan 25, 2033
US 11285129 ↗ Method of use U-3343 Jan 25, 2033
US 9549913 ↗ Method of use U-1486 Jan 25, 2033
US 11566011 ↗ Drug substance — Feb 12, 2035
US 12049457 ↗ Drug substance — Feb 12, 2035
US 10829465 ↗ Drug substance — Feb 12, 2035
US 11760740 ↗ Drug substance — Feb 12, 2035
US 10071977 ↗ Drug substance — Feb 12, 2035
FDA exclusivity
CodeWhat it grantsExpires
ODE-330Orphan Drug Exclusivity (7-year)Dec 1, 2027
Common questions
Is there a generic version of HETLIOZ 20 MG CAPSULE?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for HETLIOZ 20 MG CAPSULE. 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.

🗺️ 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 43068-0220-01, 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 – Q4 2025 · 4 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
387
Units reimbursed last 4 qtrs
11.7K
Gross reimbursed last 4 qtrs
$8.42M
Avg / prescription
$21,752.06
Avg / unit
$721.34
Latest quarter Q4 2025
96Rx
Fee-for-service vs managed care ⓘ
49% FFS 51% MCO
Fee-for-service · 191 Rx Managed care · 196 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 1,050 units · 10.5 per 100k residents MI New York: 2,280 units · 11.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 1,140 units · 16.6 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 780 units · 2.0 per 100k residents CA Utah: no data reported UT Colorado: 1,680 units · 28.6 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,310 units · 7.6 per 100k residents TX Florida: 2,430 units · 10.7 per 100k residents FL
Units reimbursed · per 100k residents
2.028.6
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 Colorado 28.6 /100k
2 Indiana 16.6 /100k
3 New York 11.6 /100k
4 Florida 10.7 /100k
5 Michigan 10.5 /100k
6 Texas 7.6 /100k
7 California 2.0 /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 Hetlioz — 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 Hetlioz. 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
$10.04M
Claims incl. refills
354
Beneficiaries
152
Spend / beneficiary
$66,049.42
Spend / claim
$28,360.20
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.

🔬 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 Hetlioz (this brand).

Top reported reactions

Insomnia715
Middle Insomnia406
Somnolence405
Headache385
Nightmare264
Abnormal Dreams223
Fatigue221

Reporter sex

5,687 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 776 8
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
43068-0220-01 You're viewing this 30 CAPSULE in 1 BOTTLE (43068-220-01) 2014-04-04 Active

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📄 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.
🎯 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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 142 words ▾

1 INDICATIONS AND USAGE HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older ( 1 ) HETLIOZ LQ oral suspension is indicated for the treatment of: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age ( 1 )

1.1Non-24-Hour Sleep-Wake Disorder (Non-24) HETLIOZ capsules are indicated for the treatment of Non-24 in adults.

1.2Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older. HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Indicated Population Dosage Form Body Weight Recommended Dosage Non-24 ( 2.2 ) Adults Capsules Not applicable 20 mg one hour prior to bedtime Nighttime sleep disturbances in SMS ( 2.3 ) Patients 16 years of age and older Capsules Not applicable 20 mg one hour prior to bedtime Pediatric Patients 3 to 15 years of age Oral Suspension ≤ 28 kg 0.7 mg/kg one hour before bedtime >28 kg 20 mg one hour before bedtime HETLIOZ capsules and HETLIOZ LQ oral suspension are not substitutable ( 2.1 ) Administer at the same time every night ( 2.2 , 2.3 ) Take without food ( 2.4 )

2.1Non-Interchangeability between HETLIOZ Capsules and HETLIOZ LQ Oral Suspension HETLIOZ capsules and HETLIOZ LQ oral suspension are not substitutable [see Clinical Pharmacology ( 12.3 )].

2.2Recommended Dosage for HETLIOZ Capsules for Non-24 Adults The recommended dosage of HETLIOZ capsules in adults is 20 mg one hour before bedtime, at the same time every night. Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months.

2.3Recommended Dosage for HETLIOZ Capsules and HETLIOZ LQ Oral Suspension for Nighttime Sleep Disturbances in SMS Patients 16 years of Age and Older The recommended dosage of HETLIOZ capsules in patients 16 years and older is 20 mg one hour before bedtime, at the same time every night. Pediatric Patients 3 Years to 15 Years of Age The recommended dosage of HETLIOZ LQ oral suspension in pediatric patients 3 years to 15 years of age is based on body weight ( Table 1 ). Administer HETLIOZ one hour before bedtime, at the same time every night.

Table 1: Recommended Dosage of HETLIOZ LQ Oral Suspension for the Treatment of Nighttime Sleep Disturbances in SMS in Pediatric Patients 3 Years to 15 Years of Age Body Weight Daily Dose (oral suspension) ≤28 kg 0.7 mg/kg one hour before bedtime >28 kg 20 mg one hour before bedtime

2.4Important Administration Information Administer HETLIOZ capsules and HETLIOZ LQ oral suspension without food [see Clinical Pharmacology ( 12.3 )]. If a patient is unable to take HETLIOZ at approximately the same time on a given night, they should skip that dose and take the next dose as scheduled. HETLIOZ LQ Oral Suspension See " Instructions for Use " for complete administration instructions.

Shake HETLIOZ LQ oral suspension well for at least 30 seconds before every administration. Remove seal and insert press-in bottle adapter (included in the package) into the neck of the bottle until a tight seal is made. Turn the bottle upside down and withdraw the prescribed amount of HETLIOZ LQ oral suspension from the bottle.

Leave the press-in bottle adapter in place on bottle neck and replace cap on bottle. Store refrigerated. After opening, discard after 5 weeks (for the 48 mL bottle) and after 8 weeks (for the 158 mL bottle).

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white. Oral suspension: 4 mg/mL white to slightly yellow opaque suspension in 48 mL or 158 mL bottles. Capsules: 20 mg ( 3 ) Oral suspension: 4 mg/mL ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions 64 words ▾

5 WARNINGS AND PRECAUTIONS May cause somnolence: After taking HETLIOZ, patients should limit their activity to preparing for going to bed, because HETLIOZ can impair the performance of activities requiring complete mental alertness ( 5.1 )

5.1Somnolence After taking HETLIOZ, patients should limit their activity to preparing for going to bed. HETLIOZ can potentially impair the performance of activities requiring complete mental alertness.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com 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. More than 2080 subjects have been treated with at least one dose of HETLIOZ, of which more than 380 have been treated for > 26 weeks and more than 170 have been treated for > 1 year. Non-24-Hour Sleep-Wake Disorder (Non-24) A 26-week, parallel-arm placebo-controlled study (Study 1) evaluated HETLIOZ (n=42) compared to placebo (n=42) in patients with Non-24.

A randomized-withdrawal, placebo- controlled study of 8 weeks duration (Study 2) also evaluated HETLIOZ (n=10), compared to placebo (n=10), in patients with Non-24. In placebo-controlled studies, 6% of patients exposed to HETLIOZ discontinued treatment due to an adverse event, compared with 4% of patients who received placebo. Table 2 shows the incidence of adverse reactions from Study 1. *Adverse reactions with an incidence > 5% and at least twice as high on HETLIOZ than on placebo are displayed.

Table 2: Adverse Reactions in Study 1 HETLIOZ N=42 Placebo N=42 Headache 17 % 7 % Alanine aminotransferase increased 10 % 5 % Nightmare/abnormal dreams 10 % 0 % Upper respiratory tract infection 7 % 0 % Urinary tract infection 7 % 2 % Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) A 9-week, double-blind, randomized, placebo-controlled, two-period crossover study evaluated HETLIOZ (capsules and oral suspension; n=25) compared to placebo (n=26) in the treatment of nighttime sleep disturbances in patients with Smith-Magenis Syndrome.

Pediatric patients (n=11, age 3 to 15 years) received HETLIOZ LQ oral suspension, and patients ≥16 years of age (n=14) received HETLIOZ capsules. Adverse reactions were similar in patients treated for Non-24 and patients with Smith-Magenis syndrome treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQ oral suspension, and patients ≥16 years of age who received HETLIOZ capsules.

🔄 Drug Interactions 167 words ▾

7 DRUG INTERACTIONS Strong CYP1A2 inhibitors (e.g., fluvoxamine): Avoid use of HETLIOZ in combination with strong CYP1A2 inhibitors because of increased exposure ( 7.1 , 12.3 ) Strong CYP3A4 inducers (e.g., rifampin): Avoid use of HETLIOZ in combination with rifampin or other CYP3A4 inducers, because of decreased exposure ( 7.2 , 12.3 )

7.1Strong CYP1A2 Inhibitors (e.g., fluvoxamine) Avoid use of HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions [see Clinical Pharmacology ( 12.3 )].

7.2Strong CYP3A4 Inducers (e.g., rifampin) Avoid use of HETLIOZ in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy [see Clinical Pharmacology ( 12.3 )].

7.3Beta-adrenergic Receptor Antagonists (e.g., acebutolol, metoprolol) Beta-adrenergic receptor antagonists have been shown to reduce the production of melatonin via specific inhibition of beta-1 adrenergic receptors. Nighttime administration of beta-adrenergic receptor antagonists may reduce the efficacy of HETLIOZ.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic impairment : HETLIOZ has not been studied in patients with severe hepatic impairment and is not recommended in these patients ( 8.6 )

8.1Pregnancy Risk Summary Available postmarketing case reports with HETLIOZ use in pregnant women are not sufficient to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In pregnant rats, no embryofetal developmental toxicity was observed at exposures of 50 mg/kg/day, or up to 24 times higher than the human exposure at the maximum recommended human dose (MRHD) (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.

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. Data Animal Data In pregnant rats administered tasimelteon at oral doses of 5, 50, or 500 mg/kg/day during the period of organogenesis, there were no effects on embryofetal development. The highest dose tested is approximately 240 times the MRHD of 20 mg/day, based on mg/m 2 body surface area.

In pregnant rabbits administered tasimelteon at oral doses of 5, 30, or 200 mg/kg/day during the period of organogenesis, embryolethality and embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. The highest dose is approximately 200 times the MRHD. Oral administration of tasimelteon at 50, 150, or 450 mg/kg/day to rats throughout organogenesis resulted in persistent reductions in body weight, delayed sexual maturation, and physical development, and neurobehavioral impairment in offspring at the highest dose tested which is approximately 220 times the MRHD based on mg/m2 body surface area.

Reduced body weight in offspring was also observed at the mid-dose. The no effect dose (NOEL), (50 mg/kg/day) is approximately 25 times the MRHD based on mg/m 2 body surface area.

8.2Lactation Risk Summary There are no data on the presence of tasimelteon or its metabolites in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HETLIOZ and any potential adverse effects on the breastfed infant from HETLIOZ or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of HETLIOZ for the treatment of Non-24 in pediatric patients have not been established. Safety and effectiveness of HETLIOZ LQ oral suspension for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) have been established in pediatric patients 3 years and older. Use is based on a placebo-controlled crossover study of pediatric and adult patients [see Clinical Studies ( 14.2 )].

Safety and effectiveness of HETLIOZ for the treatment of nighttime sleep disturbances in SMS have not been established in patients younger than 3 years old. Juvenile Animal Toxicity Data Juvenile rats received oral doses of tasimelteon at 50, 150, or 450 mg/kg from weaning (day 21) through adulthood (day 90). These doses are approximately 12 to 108 times the maximum recommended human dose (MRHD) of 20 mg based on a mg/m 2 body surface area.

Toxicity was observed mainly at the highest dose and included mortality (females only), tremors, unsteady gait, decrease in growth and development compared to controls. The former reflected as decreases in bone growth, bone mineral content, bone ossification, and a delay in attainment of sexual maturation. Tasimelteon had no effect on fertility, reproduction, or learning and memory.

The No Observed Adverse Effect Level (NOAEL) is 150 mg/kg/day, which is approximately 178 times the MRHD based on AUC.

8.5Geriatric Use The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to ta…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available postmarketing case reports with HETLIOZ use in pregnant women are not sufficient to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In pregnant rats, no embryofetal developmental toxicity was observed at exposures of 50 mg/kg/day, or up to 24 times higher than the human exposure at the maximum recommended human dose (MRHD) (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.

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. Data Animal Data In pregnant rats administered tasimelteon at oral doses of 5, 50, or 500 mg/kg/day during the period of organogenesis, there were no effects on embryofetal development. The highest dose tested is approximately 240 times the MRHD of 20 mg/day, based on mg/m 2 body surface area.

In pregnant rabbits administered tasimelteon at oral doses of 5, 30, or 200 mg/kg/day during the period of organogenesis, embryolethality and embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. The highest dose is approximately 200 times the MRHD. Oral administration of tasimelteon at 50, 150, or 450 mg/kg/day to rats throughout organogenesis resulted in persistent reductions in body weight, delayed sexual maturation, and physical development, and neurobehavioral impairment in offspring at the highest dose tested which is approximately 220 times the MRHD based on mg/m2 body surface area.

Reduced body weight in offspring was also observed at the mid-dose. The no effect dose (NOEL), (50 mg/kg/day) is approximately 25 times the MRHD based on mg/m 2 body surface area.

🧒 Pediatric Use 219 words ▾

8.4Pediatric Use Safety and effectiveness of HETLIOZ for the treatment of Non-24 in pediatric patients have not been established. Safety and effectiveness of HETLIOZ LQ oral suspension for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) have been established in pediatric patients 3 years and older. Use is based on a placebo-controlled crossover study of pediatric and adult patients [see Clinical Studies ( 14.2 )].

Safety and effectiveness of HETLIOZ for the treatment of nighttime sleep disturbances in SMS have not been established in patients younger than 3 years old. Juvenile Animal Toxicity Data Juvenile rats received oral doses of tasimelteon at 50, 150, or 450 mg/kg from weaning (day 21) through adulthood (day 90). These doses are approximately 12 to 108 times the maximum recommended human dose (MRHD) of 20 mg based on a mg/m 2 body surface area.

Toxicity was observed mainly at the highest dose and included mortality (females only), tremors, unsteady gait, decrease in growth and development compared to controls. The former reflected as decreases in bone growth, bone mineral content, bone ossification, and a delay in attainment of sexual maturation. Tasimelteon had no effect on fertility, reproduction, or learning and memory.

The No Observed Adverse Effect Level (NOAEL) is 150 mg/kg/day, which is approximately 178 times the MRHD based on AUC.

🧓 Geriatric Use 32 words ▾

8.5Geriatric Use The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to tasimelteon is increased by approximately 2-fold compared with younger patients.

🆘 Overdosage 125 words ▾

10 OVERDOSAGE There is limited premarketing clinical experience with the effects of an overdosage of HETLIOZ. As with the management of any overdose, general symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed.

Respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures employed. While hemodialysis was effective at clearing HETLIOZ and the majority of its major metabolites in patients with renal impairment, it is not known if hemodialysis will effectively reduce exposure in the case of overdose. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.

Contact a poison control center for current information on the management of overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which tasimelteon exerts its therapeutic effect in patients with Non-24 or nighttime sleep disturbances in SMS is unclear. However, tasimelteon is an agonist at melatonin MT 1 and MT 2 receptors which are thought to be involved in the control of circadian rhythms.

12.2Pharmacodynamics Tasimelteon is an agonist at MT 1 and MT 2 receptors with greater affinity for the MT 2 as compared to the MT 1 receptor (Ki = 0.304 nM and 0.07 nM, respectively). The major metabolites of tasimelteon have less than one-tenth of the binding affinity of the parent molecule for both the MT 1 and MT 2 receptors.

12.3Pharmacokinetics The pharmacokinetics of tasimelteon is linear over doses ranging from 3 to 300 mg (0.15 to 15 times the recommended daily dosage). The pharmacokinetics of tasimelteon and its metabolites did not change with repeated daily dosing. Absorption The absolute oral bioavailability is 38.3%.

The peak concentration (T max ) of tasimelteon capsule occurred approximately 0.5 to 3 hours after fasted oral administration. The Tmax of tasimelteon suspension occurred approximately 15 to 30 minutes after fasted oral administration. The pharmacokinetic profile of oral suspension has not been directly compared to capsules; therefore, capsules are the only dosage form recommended for use in adults.

Effect of food When administered with a high-fat meal, the Cmax of tasimelteon was 44% lower than when given in a fasted state, and the median Tmax was delayed by approximately 1.75 hours. Therefore, HETLIOZ should be taken without food. Distribution The apparent oral volume of distribution of tasimelteon at steady state in young healthy subjects is approximately 59 - 126 L.

At therapeutic concentrations, tasimelteon is about 90% bound to proteins. Metabolism Tasimelteon is extensively metabolized. Metabolism of tasimelteon consists primarily of oxidation at multiple sites and oxidative dealkylation resulting in opening of the dihydrofuran ring followed by further oxidation to give a carboxylic acid.

CYP1A2 and CYP3A4 are the major isozymes involved in the metabolism of tasimelteon. Phenolic glucuronidation is the major phase II metabolic route. Major metabolites had 13-fold or less activity at melatonin receptors compared to tasimelteon.

Elimination Following oral administration of radiolabeled tasimelteon, 80% of total radioactivity was excreted in urine and approximately 4% in feces, resulting in a mean recovery of 84%. Less than 1% of the dose was excreted in urine as the parent compound. The observed mean elimination half-life for tasimelteon is 1.3 ± 0.4 hours.

The mean terminal elimination half-life ± standard deviation of the main metabolites ranges from 1.3 ± 0.5 to 3.7 ± 2.2. Repeated once daily dosing with HETLIOZ does not result in changes in pharmacokinetic parameters or significant accumulation of tasimelteon. Studies in Specific Populations Elderly In elderly subjects, tasimelteon exposure increased by approximately two-fold compared with non-elderly adults.

Pediatric Patients Pharmacokinetic information in pediatric patients are available only for the oral suspension formulation. Body weight was found to have significant effect on the pharmacokinetics. The increase in body weight was associated with increase in tasimelteon clearance up to 28 kg.

The average dose normalized Cmax and AUC inf at the recommended dose was 231 ng/mL and 310 ng.h/mL. No data are available in patients less than 3 years old. Gender The mean overall exposure of tasimelteon was approximately 20-30% greater in female than in male subjects.

Race The effect of race on exposure of HETLIOZ was not evaluated. Hepatic Impairment The pharmacokinetic profile of a 20 mg dose of HETLIOZ was compared among eight subjects with mild hepatic impairment (Child-Pugh Score ≥5 and ≤6 points), eight subjects with moderate hepatic impairment (Child-Pugh Score ≥7 and ≤9 points), and 13 healthy matched controls.…

🧬 Mechanism of Action 50 words ▾

12.1Mechanism of Action The mechanism by which tasimelteon exerts its therapeutic effect in patients with Non-24 or nighttime sleep disturbances in SMS is unclear. However, tasimelteon is an agonist at melatonin MT 1 and MT 2 receptors which are thought to be involved in the control of circadian rhythms.

📦 How Supplied / Storage and Handling 168 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING HETLIOZ Capsules 20 mg capsules are available as size 1, dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white, containing 20 mg of tasimelteon per capsule. NDC 43068-220-01 Bottles of 30 capsules NDC 43068-220-02 Blister Pack containing 3 capsules HETLIOZ LQ Oral Suspension 4 mg/mL white to slightly yellow opaque suspension. Each bottle has a child resistant cap and packaged in a carton.

Each carton contains a bottle of HETLIOZ LQ oral suspension, a 5 mL oral dosing syringe and a press-in bottle adapter. NDC 43068-304-02 Bottles of 48 mL NDC 43068-304-06 Bottles of 158 mL Storage and Handling HETLIOZ Capsules Store HETLIOZ capsules at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from exposure to light and moisture.

HETLIOZ LQ Oral Suspension Store HETLIOZ LQ oral suspension at refrigerated temperature 5°C (41°F); excursions permitted to 2°C to 8°C (36°F t o 46°F).

📦 Storage and Handling 63 words ▾

Storage and Handling HETLIOZ Capsules Store HETLIOZ capsules at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from exposure to light and moisture. HETLIOZ LQ Oral Suspension Store HETLIOZ LQ oral suspension at refrigerated temperature 5°C (41°F); excursions permitted to 2°C to 8°C (36°F t o 46°F).

📋 Description 177 words ▾

11 DESCRIPTION HETLIOZ contains tasimelteon, a melatonin receptor agonist, chemically designated as (1 R , 2 R )-N-[2- (2,3-dihydrobenzofuran-4-yl)cyclopropylmethyl]propanamide, containing two chiral centers. The molecular formula is C 15 H 19 NO 2 , and the molecular weight is 245.32. The structural formula is: Tasimelteon is a white to off-white crystalline powder. It is very slightly soluble in cyclohexane, slightly soluble in water and

0.1N hydrochloric acid, and freely soluble or very soluble in methanol, 95% ethanol, acetonitrile, isopropanol, polyethylene glycol 300, propylene glycol and ethyl acetate. HETLIOZ capsules are intended for oral administration. Each capsule contains 20 mg of tasimelteon and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose.

Each hard gelatin capsule consists of FD&C Blue #1, FD&C Red #3, and FD&C Yellow #6, gelatin, and titanium dioxide. HETLIOZ LQ oral suspension contains 4 mg of tasimelteon per mL of suspension and the following inactive ingredients: ascorbic acid, cherry flavor, mannitol, microcrystalline cellulose/carboxymethylcellulose sodium, polysorbate 80, sodium benzoate, sodium chloride, sucrose, sucralose, and water. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling for HETLIOZ LQ oral suspension, if appropriate ( Instructions for Use ). Advise patients to limit their activities to preparing for going to bed after taking HETLIOZ capsules or HETLIOZ LQ oral suspension because HETLIOZ can potentially impair the performance of activities requiring complete mental alertness [see Warnings and Precautions ( 5.1 )]. Administration Information for HETLIOZ capsules and HETLIOZ LQ oral suspension [see Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 )] .

Advise patients to take HETLIOZ without food. Advise patients to take HETLIOZ before bedtime at the same time every night. Advise patients to skip the dose that night if they cannot take HETLIOZ at approximately the same time on a given night.

Advise patients to swallow HETLIOZ capsules whole. HETLIOZ LQ oral suspension: Advise patients to shake the bottle for at least 30 seconds before each administration; use the press-in bottle adapter included in the package; leave the adapter in place on the bottle neck; replace the cap; and refrigerate after each use. After opening, discard after 5 weeks (for the 48 mL bottle) and after 8 weeks (for the 158 mL bottle).

Non-24 (HETLIOZ capsules) Advise patients that because of individual differences in circadian rhythms, daily use for several weeks or months may be necessary before benefit from HETLIOZ is observed [see Dosage and Administration ( 2.2 )] . Distributed by: Vanda Pharmaceuticals Inc. Washington, D.C.

20037 USA www.hetlioz.com Vanda, HETLIOZ, and HETLIOZ LQ are registered trademarks of Vanda Pharmaceuticals Inc. in the United States and other countries.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43068-0115-04 · Vanda 43068-0304-02 · Vanda →
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.