Suvorexant

(Belsomra®)

Suvorexant

Drug updated on 9/4/2024

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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  • Belsomra (suvorexant) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
  • This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-15]
  • Suvorexant (20 mg and 40 mg) and daridorexant (10 mg and 50 mg) showed the most significant reduction in Latency to Persistent Sleep (LPS).
  • Lemborexant (5 mg and 10 mg) was the most effective for reducing Subjective Sleep Onset Time (sTSO).
  • Suvorexant 40 mg and lemborexant 10 mg may have been the most effective for increasing Total Sleep Time (TST), particularly subjective TST (sTST).
  • Suvorexant (OR = 0.30) and suvorexant combined with ramelteon (OR = 0.39) reduced the incidence of delirium in adult hospitalized patients.
  • Common adverse effects associated with insomnia treatments included somnolence, fatigue, abnormal dreams, and dry mouth, with higher doses of suvorexant (40 mg and 80 mg) showing increased safety risks (RR 1.09 and 1.65, respectively).
  • No significant differences were observed in severe adverse events between suvorexant and placebo, except for instances of somnolence and excessive daytime sleepiness, with no significant differences in the rates of hallucinations, suicidal ideation/behavior, or motor vehicle accidents.
  • Lemborexant demonstrated a lower incidence of adverse effects compared to higher doses of suvorexant, with no significant driving performance impairment noted for lemborexant.
  • Insomnia treatments are effective and safe for older adults, with suvorexant improving sleep maintenance with mild side effects, making it suitable for this population. Suvorexant, with or without ramelteon, effectively reduces delirium incidence in elderly hospitalized patients and benefits patients with Alzheimer's disease by increasing total sleep time and sleep efficiency while reducing wake after sleep onset time.

Product Monograph / Prescribing Information

Document TitleYearSource
Belsomra (suvorexant) prescribing information.2023Merck & Co., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Different doses of dual orexin receptor antagonists in primary insomnia: A Bayesian network analysis. 2023Frontiers in Pharmacology
The comparative effectiveness and safety of insomnia drugs: A systematic review and network meta-analysis of 153 randomized trials.2023Drugs
Dual orexin receptor antagonists for the treatment of insomnia: Systematic review and network meta-analysis.2023Arquivos de Neuro-psiquiatria
Understanding the unmet needs in insomnia treatment: A systematic literature review of real-world evidence.2023The 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 lemborexant.2022Frontiers 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-analysis.2022The Lancet
Suvorexant with or without ramelteon to prevent delirium: A systematic review and meta-analysis. 2022Psychogeriatrics
Suvorexant for the treatment of primary insomnia: A systematic review and meta-analysis.2022Sleep Medicine Reviews
Comparative efficacy of lemborexant and other insomnia treatments: A network meta-analysis.2021Journal of Managed Care + Speciality Pharmacy
The efficacy and safety of dual orexin receptor antagonists in primary insomnia: A systematic review and network meta-analysis. 2021Sleep Medicine Reviews
Comparison of the effect of lemborexant and other insomnia treatments on driving performance: A systematic review and meta-analysis.2021Sleep Advances
Pharmacological and non-pharmacological interventions to enhance sleep in mild cognitive impairment and mild Alzheimer's disease: A systematic review.2021Journal of Sleep Research
Evidence-based insomnia treatment strategy using novel orexin antagonists: A review.2021Neuropsychopharmacology Reports
Lemborexant vs suvorexant for insomnia: A systematic review and network meta-analysis.2020Journal of Psychiatric Research
Efficacy and safety of non-benzodiazepine and non-Z-drug hypnotic medication for insomnia in older people: A systematic literature review.2020European Journal of Clinical Pharmacology

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