Suvorexant

(Belsomra®)

Suvorexant

Drug updated on 11/1/2024

Dosage FormTablet (oral; 5 mg, 10 mg, 15 mg, 20 mg)
Drug ClassOrexin receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

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Summary
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  • This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
  • Latency to Persistent Sleep (LPS) Reduction: Suvorexant (20 and 40 mg) and daridorexant (10 and 50 mg) were among the most effective treatments for reducing LPS, with both suvorexant and lemborexant showing significant reductions in LPS compared to placebo.
  • Subjective Sleep Onset Time (sTSO) Reduction: Lemborexant (5 and 10 mg) demonstrated the highest effectiveness in reducing sTSO, performing better than suvorexant in certain studies.
  • Wake Time After Sleep Onset (WASO): Reductions in WASO were observed for all drugs except daridorexant 5 mg, with lemborexant 10 mg and suvorexant 20/15 mg showing the largest impacts in both short-term and long-term WASO.
  • Total Sleep Time (TST) and Subjective Total Sleep Time (sTST): Suvorexant 40 mg and lemborexant 10 mg showed the highest effectiveness in increasing TST and sTST, with lemborexant having a high probability of being the best treatment for improving TST across studies.
  • Common Adverse Events: Suvorexant was associated with somnolence, excessive daytime sleepiness, sedation, dry mouth, back pain, fatigue, and abnormal dreams, while lemborexant commonly reported somnolence and nightmares, with both drugs showing no significant differences from placebo in hallucinations, suicidal ideation/behavior, or motor vehicle accidents.
  • Serious Adverse Events (SAEs): Neither suvorexant nor lemborexant demonstrated a significant increase in serious adverse events compared to placebo.
  • Discontinuation Due to Adverse Events and Driving Performance: Discontinuation rates due to adverse events were comparable between lemborexant, suvorexant, and placebo. Lemborexant had no clinically significant effect on driving performance, while suvorexant was linked to some premature terminations in driving studies.
  • Studies included older adults and individuals with psychiatric comorbidities such as depression and bipolar disorder, with both suvorexant and lemborexant demonstrating effectiveness in treating insomnia across these groups, showing similar efficacy and safety profiles in older adults as in general adult populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Belsomra (suvorexant) Prescribing Information.2023Merck & Co., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Orexin receptor antagonists in the treatment of insomnia associated with psychiatric disorders: a systematic review2024Translational Psychiatry
Residual effects of medications for sleep disorders on driving performance: A systematic review and network meta-analysis of randomized controlled trials: NMA driving and hypnotics2024The Journal of the European College of Neuropsychopharmacology
Different doses of dual orexin receptor antagonists in primary insomnia: a Bayesian network analysis2023Frontiers in Pharmacology
Dual orexin receptor antagonists for the treatment of insomnia: systematic review and network meta-analysis2023Arquivos de Neuro-Psiquiatria
Understanding the unmet needs in insomnia treatment: a systematic literature review of real-world evidence2023The International Journal of Neuroscience
Dual orexin receptor antagonists for treatment of insomnia: A systematic review and meta-analysis on randomized, double-blind, placebo-controlled trials of suvorexant and lemborexant2022Frontiers in Psychiatry
Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis2022Lancet
Evidence-based insomnia treatment strategy using novel orexin antagonists: A review2021Neuropsychopharmacology Reports
Comparison of the effect of lemborexant and other insomnia treatments on driving performance: a systematic review and meta-analysis2021 Sleep Advances
Comparative efficacy of lemborexant and other insomnia treatments: a network meta-analysis2021 Journal of Managed Care & Specialty Pharmacy
Lemborexant vs suvorexant for insomnia: A systematic review and network meta-analysis2020Journal of Psychiatric Research

Clinical Practice Guidelines