Lemborexant (Dayvigo) is a selective orexin receptor antagonist used for the treatment of insomnia in adults, particularly in patients with difficulty falling asleep and/or difficulty maintaining sleep.

Indications for Lemborexant (Dayvigo)

Core Uses

Indicated for the treatment of insomnia in adults, which presents as difficulty falling asleep and/or difficulty maintaining sleep.

It improves sleep quality by inhibiting orexin receptors and reducing wakefulness signals.

Dosage Forms, Specifications and Properties of Lemborexant (Dayvigo)

Dosage Forms and Specifications

Tablets: Available in two strengths, 5mg and 10mg.

5mg tablets: Light yellow, round, biconvex film-coated tablets, engraved with "5" on one side and "LЄM" on the other side.

10mg tablets: Orange, round, biconvex film-coated tablets, engraved with "10" on one side and "LЄM" on the other side.

Ingredients and Properties

Active ingredient: Each tablet contains 5mg or 10mg of lemborexant.

Excipients: Hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, etc.; the film coating layer contains hypromellose, polyethylene glycol 8000, talc, titanium dioxide, and colorants (yellow iron oxide or red iron oxide).

Storage conditions: Store at 20°C to 25°C (68°F to 77°F); short-term storage within the range of 15°C to 30°C (59°F to 86°F) is permitted.

Dosage and Administration of Lemborexant (Dayvigo)

Routine Dosage

Recommended adult dosage: The initial dose is 5mg, administered once daily at night, immediately before bedtime. It is necessary to ensure at least 7 hours of sleep after taking the medication.

Based on clinical response and tolerability, the dose may be increased to the maximum recommended dose of 10mg.

Dietary requirements: Avoid taking with meals or immediately after meals, as this may delay the time to fall asleep.

Patients with Hepatic Impairment

Moderate impairment (Child-Pugh Class B): The maximum recommended dose is 5mg per day.

Severe impairment (Child-Pugh Class C): Use is not recommended.

Patients with Renal Impairment

No dosage adjustment is required for mild to moderate impairment, but caution is advised in patients with end-stage renal disease.

Drug Interactions

CYP3A inhibitors: Concomitant use with strong or moderate CYP3A inhibitors should be avoided; when used concomitantly with weak CYP3A inhibitors, the maximum dose is 5mg.

CYP3A inducers: Concomitant use with strong or moderate CYP3A inducers should be avoided.

Alcohol: Concomitant use with alcohol is prohibited, as it may enhance the central nervous system depressant effect.