Molecule
Lemborexant 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 Lemborexant 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.
DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. DAYVIGO 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 lemborexant 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
Recommended dose is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. Dosage may be increased to 10 mg based on clinical response and tolerability. The maximum recommended dose is 10 mg once daily. Time to sleep onset may be delayed if taken with or soon after a meal. Hepatic Impairment: ○ Moderate hepatic impairment: Initial and maximum recommended dosage is 5 mg no more than once per night. ○ Severe hepatic impairment: Not recommended.
Source: US FDA prescribing information
DAYVIGO is contraindicated in patients with narcolepsy.
Source: US FDA prescribing information
CNS Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases with dose and use with other central nervous system (CNS) depressants. For patients taking DAYVIGO 10 mg, caution against next-day driving and other activities requiring complete mental alertness. Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with use of DAYVIGO. 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. Compromised Respiratory Function: Effect on respiratory function should be considered. Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: CNS Depressant Effects and Daytime Impairment Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms Complex Sleep Behaviors Patients with Compromised Respiratory Function Worsening of Depression/Suicidal Ideation The most common adverse reaction (reported in ≥5% of patients treated with DAYVIGO and at least twice the rate of placebo) was somnolence.
Source: US FDA prescribing information
Strong or moderate CYP3A inhibitors: Avoid concomitant use. Weak CYP3A inhibitors: The maximum recommended dose is 5 mg. Strong or moderate CYP3A 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 Lemborexant, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Dayvigo 10 mg tabletOral | Eisai | US FDA | Available on request |
| Dayvigo 5 mg tabletOral | Eisai | 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 20 December 2019 | 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 |
Yes, on request. MedsAcross lists 2 presentations of Lemborexant and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Lemborexant, including Dayvigo.
Yes. The US FDA first approved Lemborexant on 20 December 2019, according to Drugs@FDA.
No listed presentation of Lemborexant is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.