Suvorexant

(Belsomra®)

Belsomra®

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Drug updated on 4/16/2024

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.

Summary
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  • Suvorexant (Belsomra) is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. It has demonstrated effectiveness in reducing latency to persistent sleep and increasing total sleep time compared to placebo.
  • A review of 15 systematic reviews/meta-analyses focused on suvorexant's safety, effectiveness, and comparison with other drugs for treating insomnia such as dual orexin receptor antagonists (DORAs), benzodiazepines, Z-drugs, among others.
  • In terms of efficacy in managing insomnia symptoms, suvorexant showed similar rates in improving both the initiation times and maintaining restful slumber when compared to other DORAs like daridorexant and lemborexant.
  • When comparing suvorexant with non-benzodiazepines, it displayed significant improvements in subjectively measured total sleeping hours. Its effect on shortening the time taken to fall asleep also proved positive, showing comparable or superior performance against zopiclone and antidepressants.
  • Higher doses of suvorexant exhibited increased safety risks over placebo but were generally consistent with the safety profiles observed from using other DORAs like daridorexant or lemboreaxnt. Common adverse events included somnolence, nasopharyngitis, and headache.
  • While certain doses resulted in higher incidences of drowsiness along with mild-to-moderate side effects, they were generally well-tolerated; their associated health concerns mirrored those found when using other medications designed for combating insomnia including Z-drugs and some non-benzodiazepine aids used during bedtime.
  • Suvorexant's effectiveness remained broadly similar across adult populations, including older individuals without any statistically significant differences between these groups, suggesting that this drug could be a viable option for elderly patients who often exhibit greater sensitivity towards negative impacts caused by medication meant specifically for addressing issues related to insomnia.
  • Although not extensively covered in the studies, suvorexant's safety profile and its ability to manage symptoms of a "complex 24-hour sleep disorder" hint at potential applicability for patients with comorbid conditions. However, more evidence is needed before drawing robust conclusions.

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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