Tasimelteon is a melatonin receptor agonist indicated for the treatment of non-24-Hour Sleep-Wake Disorder (Non-24) in adults, among other approved uses. It is available as capsules and oral suspension. MedsAcross supplies Tasimelteon for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Indicated Population Dosage Form Body Weight Recommended Dosage Non-24. Adults Capsules Not applicable 20 mg one hour prior to bedtime Nighttime sleep disturbances in SMS. 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. Administer at the same time every night. Take without food
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
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
Source: US FDA prescribing information
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
Source: US FDA prescribing information
Strong CYP1A2 inhibitors (e.g., fluvoxamine): Avoid use of HETLIOZ in combination with strong CYP1A2 inhibitors because of increased exposure. Strong CYP3A4 inducers (e.g., rifampin): Avoid use of HETLIOZ in combination with rifampin or other CYP3A4 inducers, because of decreased exposure
Source: US FDA prescribing information
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). 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). Protect from exposure to light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Tasimelteon, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tasimelteon 20 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Hetlioz 20 mg capsuleOral Cold chain | Vanda Pharmaceuticals | US FDA | Available on request |
| Hetlioz LQ 4 mg/mL oral suspensionOral Cold chain | Vanda Pharmaceuticals | US FDA | Available on request |
2 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 3 presentations of Tasimelteon and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Tasimelteon, including Hetlioz, Hetlioz LQ.
Yes. The US FDA first approved Tasimelteon on 31 January 2014, according to Drugs@FDA.
Yes. Tasimelteon has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Tasimelteon must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tasimelteon is classified under ATC code N05CH03 (Tasimelteon).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.