Quick answers
- What is Tasimelteon used for?
- The FDA-approved label (Hetlioz, Vanda Pharmaceuticals Inc., August 4, 2026) says: “HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older HETLIOZ LQ oral suspension is indicated for the treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tasimelteon have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tasimelteon?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tasimelteon been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tasimelteon?
- 4 companies list prescription products of Tasimelteon in the FDA NDC Directory, including Vanda Pharmaceuticals Inc., Apotex Corp. and Teva Pharmaceuticals, Inc..
What Tasimelteon is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older HETLIOZ LQ oral suspension is indicated for the treatment of …
— FDA label: Hetlioz, Vanda Pharmaceuticals Inc., effective August 4, 2026. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Suspension · Capsule, gelatin coated |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Hetlioz Lq, Hetlioz |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tasimelteon 20 mg capsule | Generic | $213.56 per capsule |
| tasimelteon 20 mg capsule, gelatin coated | Generic | $213.56 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Vanda Pharmaceuticals Inc.2 products
- Apotex Corp.1 product
- Teva Pharmaceuticals, Inc.1 product
- Amneal Pharmaceuticals NY LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA205677 HETLIOZ | Vanda Pharms Inc | January 31, 2014 | 5, latest July 27, 2026 2026: Manufacturing (CMC) · 2020: Efficacy · 2019: Labeling |
| NDA214517 HETLIOZ LQ | Vanda Pharms Inc | December 1, 2020 | — |
Generic approvals (3)
- ANDA211601Teva Pharms USA Inc · December 12, 2022
- ANDA211607Apotex · December 20, 2022
- ANDA211654Msn · January 12, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1490473, 1491624, 2468312, 2468316 |
|---|---|
| SPL set ID of the quoted label | ca4a9b63-708e-49e9-8f9b-010625443b90 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA205677, NDA214517, 3 ANDA |
| Active ingredients (FDA) | TASIMELTEON |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hetlioz, Vanda Pharmaceuticals Inc., effective August 4, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →