Lemborexant

(Dayvigo®)

Dayvigo®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 5 mg, 10 mg)
Drug ClassOrexin 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
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  • 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 TitleYearSource
Dayvigo (lemborexant) Prescribing Information.2023Eisai Inc., Nutley, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Residual effects of medications for sleep disorders on driving performance: a systematic review and network meta-analysis of randomized controlled trials: NMA driving and hypnotics.2024European Neuropsychopharmacology
Clinical safety and narcolepsy-like symptoms of dual orexin receptor antagonists in patients with insomnia: a systematic review and meta-analysis.2024Sleep Research Society
Different doses of dual orexin receptor antagonists in primary insomnia: a Bayesian network analysis.2023Frontiers in Pharmacology
Comparative efficacy and safety of lemborexant 5 mg versus 10 mg for the treatment of insomnia: a systematic review.2023Neurological Sciences
The comparative effectiveness and safety of insomnia drugs: a systematic review and network meta-analysis of 153 randomized trials.2023Drugs
Efficacy and tolerability of pharmacological treatments for insomnia in adults: a systematic review and network meta-analysis.2023Sleep Medicine Reviews
The efficacy and safety of dual orexin receptor antagonists in primary insomnia: a systematic review and network meta-analysis.2022Sleep Medicine Reviews
Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis.2022The Lancet
Review of the efficacy and safety of lemborexant, a dual receptor orexin antagonist (DORA), in the treatment of adults with insomnia disorder.2021Annals of Pharmacotherapy
Comparative efficacy of lemborexant and other insomnia treatments: a network meta-analysis.2021Journal of Managed Care & Specialty Pharmacy
Comparison of the effect of lemborexant and other insomnia treatments on driving performance: a systematic review and meta-analysis.2021Sleep Advances
Pharmacotherapies for sleep disturbances in dementia.2020The Cochrane Database of Systematic Reviews
Lemborexant vs suvorexant for insomnia: a systematic review and network meta-analysis.2020Journal of Psychiatric Research