Suvorexant is an orexin receptor antagonist indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. It is available as tablets for oral use. MedsAcross supplies Suvorexant 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.
BELSOMRA ® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Source: US FDA prescribing information
The mechanism of action of suvorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.
Source: US FDA prescribing information
Use the lowest dose effective for the patient. Recommended dose is 10 mg, no more than once per night taken within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg once daily. Time to effect may be delayed if taken with or soon after a meal.
Source: US FDA prescribing information
BELSOMRA is contraindicated in patients with narcolepsy.
Source: US FDA prescribing information
CNS Depressant Effects and Daytime Impairment: Risk of impaired alertness and motor coordination, including impaired driving, risk increases with dose, caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness. Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Risk increases with dose. Immediately evaluate any new behavioral changes. Complex Sleep Behaviors: Behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur. Discontinue immediately if a complex sleep behavior occurs. Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with the use of BELSOMRA. Compromised Respiratory Function: Effect on respiratory function should be considered.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections: CNS Depressant Effects and Daytime Impairment Worsening of Depression/Suicidal Ideation Complex Sleep Behaviors Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms Patients with Compromised Respiratory Function The most common adverse reaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) with BELSOMRA was somnolence.
Source: US FDA prescribing information
CYP3A inhibitors: Recommended dose is 5 mg when used with moderate CYP3A inhibitors. Dose can be increased to 10 mg once per night if the 5 mg dose is not effective. Not recommended for use in patients taking strong CYP3A inhibitors. Strong CYP3A inducers: Efficacy may be reduced. Digoxin: Monitor digoxin concentrations.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F),. Store in the original package until use to protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Suvorexant, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Belsomra 10 mg tabletOral | Merck Sharp & Dohme | US FDA | Available on request |
| Belsomra 15 mg tabletOral | Merck Sharp & Dohme | US FDA | Available on request |
| Belsomra 20 mg tabletOral | Merck Sharp & Dohme | US FDA | Available on request |
| Belsomra 5 mg tabletOral | Merck Sharp & Dohme | US FDA | Available on request |
1 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.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 13 August 2014 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Suvorexant in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Suvorexant and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Suvorexant, including Belsomra.
Yes. The US FDA first approved Suvorexant on 13 August 2014, according to Drugs@FDA.
No listed presentation of Suvorexant is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Suvorexant is classified under ATC code N05CJ01 (Suvorexant).
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