DAYVIGO

LEMBOREXANT

Manufacturer: Eisai Inc.

Score: 141.0

Quick Summary

DAYVIGO (LEMBOREXANT) is an orexin receptor antagonist used for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The recommended dosage 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. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability. DAYVIGO is contraindicated in patients with narcolepsy and has important safety information, including warnings about CNS depressant effects and daytime impairment, sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance
Orexin receptor antagonist
Improves sleep onset and sleep maintenance

Important Safety Information

Warning

CNS depressant effects and daytime impairment, sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms

Contraindications

Narcolepsy

Adverse Reactions

Somnolence
Headache
Nightmare or abnormal dreams

Dosing Recommendations

General Guidance

The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability

Insomnia

Adult Dose

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

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

There are no available data on DAYVIGO use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes

Nursing Mothers

Not specified

Pediatric Use

The safety and effectiveness of DAYVIGO have not been established in pediatric patients

Geriatric Use

Exercise caution when using doses higher than 5 mg in patients ≥65 years old
The incidence of somnolence in patients ≥65 years with DAYVIGO 10 mg was higher compared to 7.7% in patients <65 years