Daridorexant is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. It is available as tablets for oral use. MedsAcross supplies Daridorexant 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.
QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. QUVIVIQ is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Source: US FDA prescribing information
The mechanism of action of daridorexant 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
The recommended dosage is 25 mg to 50 mg once per night, taken orally within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening. Time to sleep onset may be delayed if taken with or soon after a meal. Hepatic Impairment: Moderate hepatic impairment: Maximum recommended dosage is 25 mg no more than once per night. Severe hepatic impairment: Not recommended.
Source: US FDA prescribing information
QUVIVIQ is contraindicated: in patients with narcolepsy. in patients with a history of hypersensitivity to daridorexant or any components of QUVIVIQ. Angioedema with pharyngeal involvement has been reported. Narcolepsy. Known hypersensitivity to daridorexant or other components of QUVIVIQ.
Source: US FDA prescribing information
CNS-Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases when used with other central nervous system (CNS) depressants. For patients taking QUVIVIQ, caution against next-day driving and other activities requiring complete mental alertness. Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with use of QUVIVIQ. Complex Sleep Behaviors: Behaviors including sleepwalking, sleep driving, and engaging in other activities while not fully awake may occur. Discontinue immediately if complex sleep behavior occurs. Compromised Respiratory Function: Effect on respiratory function should be considered.
Source: US FDA prescribing information
The following are discussed in detail in other sections of the labeling: CNS-Depressant Effects and Daytime Impairment Worsening of Depression/Suicidal Ideation Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms Complex Sleep Behaviors Patients with Compromised Respiratory Function The most common adverse reactions (reported in ≥ 5% of patients treated with QUVIVIQ and at an incidence ≥ than placebo) were headache and somnolence or fatigue.
Source: US FDA prescribing information
Strong CYP3A4 inhibitors: Avoid concomitant use. Moderate CYP3A4 inhibitors: Maximum recommended dose is 25 mg. Moderate or Strong CYP3A4 inducers: Avoid concomitant use.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Daridorexant, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Quviviq 25 mg tabletOral | Idorsia Pharmaceuticals | US FDA | Available on request |
| Quviviq 50 mg tabletOral | Idorsia Pharmaceuticals | 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.
Yes, on request. MedsAcross lists 2 presentations of Daridorexant and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Daridorexant, including Quviviq.
Yes. The US FDA first approved Daridorexant on 7 January 2022, according to Drugs@FDA.
Yes. Daridorexant has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Daridorexant is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Daridorexant is classified under ATC code N05CJ03 (Daridorexant).
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