For research and educational purposes only. Not medical advice.
Suvorexant Reference
Educational, not medical advice reference for Suvorexant: Sleep; regulatory status, evidence posture, source review, and schedule notes. Also known as Belsom…
Reference summary
First dual orexin receptor antagonist (DORA) approved by the FDA. Pivotal evidence is Herring 2016 Biol Psychiatry (two 3-month randomized placebo-controlled trials in adults with primary insomnia) plus Michelson 2014 Lancet Neurol (1-year safety with abrupt-discontinuation follow-up). Both reported modest but reproducible improvements in subjective and polysomnography-measured sleep parameters.
Regulatory and posture
- Categories
- Sleep
- Aliases
- Belsomra, MK-4305, Dual orexin receptor antagonist (DORA, small molecule, not a peptide)
- Evidence posture
- human - Modest effect size; daytime somnolence and next-day driving impairment are documented label warnings.
- Regulatory status
- FDA-approved as Belsomra (2014) for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Schedule IV controlled substance under the US Controlled Substances Act.
- Content review status
- label verified
Selected public sources
- DailyMed: Belsomra (suvorexant) prescribing information
- PubMed: Herring et al. Biol Psychiatry 2016 - suvorexant in patients with insomnia, results from two 3-month randomized controlled clinical trials (PMID 25526970)
- PubMed: Michelson et al. Lancet Neurol 2014 - safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation, a phase 3 randomised trial (PMID 24680372)