Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 5 mg, 10 mg) |
Drug Class | Orexin receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
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Summary
- Dayvigo (lemborexant) is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
- Lemborexant (5 mg and 10 mg) effectively reduced subjective sleep onset time (sTSO) and subjective wake after sleep onset (sWASO), showing significant improvements in sleep efficiency (SE) and Insomnia Severity Index (ISI) scores.
- Suvorexant (20 mg and 40 mg) and daridorexant (10 mg and 50 mg) were effective in reducing latency to persistent sleep (LPS) and increasing total sleep time (TST), with Suvorexant (40 mg) being particularly effective for subjective total sleep time (sTST).
- Lemborexant demonstrated a dose-dependent effectiveness, with higher doses yielding better outcomes in sleep measures and a safety profile similar to other treatments, particularly in older adults.
- Comparatively, Lemborexant and Suvorexant showed comparable effectiveness in reducing sTSO, sTST, and sWASO, with Lemborexant ranking higher in subjective measures at 4 weeks.
- Common adverse events associated with lemborexant included somnolence, headache, dizziness, urinary tract infections (UTIs), and upper respiratory tract infections.
- DORAs, including lemborexant, showed a higher incidence of treatment-emergent adverse events (TEAEs) such as excessive daytime sleepiness (EDS) and sleep paralysis compared to placebo.
- Serious adverse events for lemborexant were similar to other treatments, with no significant cognitive or psychomotor impairment observed.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Dayvigo (lemborexant) Prescribing Information. | 2023 | Eisai Inc., Nutley, NJ |