Hetlioz Vanda Pharmaceuticals Netherlands B.V. · Authorised · authorised 3 Jul 2015 · ATC N05CH
Therapeutic indication (EMA)
Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Active substance
Tasimelteon
- US FDA 5
- EMA 1
- US price lines 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| HETLIOZ | 20MG | capsule · oral | VANDA PHARMS INC | Prescription | 31 Jan 2014 |
| HETLIOZ LQ | 4MG/ML | suspension · oral | VANDA PHARMS INC | Prescription | 1 Dec 2020 |
| TASIMELTEON | 20MG | capsule · oral | TEVA PHARMS USA INC | Prescription | 12 Dec 2022 |
| TASIMELTEON | 20MG | capsule · oral | APOTEX | Prescription | 20 Dec 2022 |
| TASIMELTEON | 20MG | capsule · oral | MSN | Prescription | 12 Jan 2023 |
EMA European Union — centrally authorised medicines
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TASIMELTEON 20 MG CAPSULE | $228.24801 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 1 Dec 2020 HETLIOZ — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.