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Suvorexant (Belsomra)
Suvorexant blocks orexin receptors in the brain to reduce wakefulness and promote sleep.
Suvorexant blocks orexin receptors in the brain to reduce wakefulness and promote sleep. Used for Insomnia (sleep onset and sleep maintenance).
At a glance
| Generic name | Suvorexant (Belsomra) |
|---|---|
| Sponsor | Massachusetts General Hospital |
| Drug class | Orexin receptor antagonist |
| Target | Orexin receptor 1 (OX1R) and Orexin receptor 2 (OX2R) |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | FDA-approved |
Mechanism of action
Suvorexant is an orexin receptor antagonist that inhibits the activity of orexin neuropeptides, which are responsible for promoting wakefulness. By blocking orexin signaling, the drug reduces the drive to stay awake and facilitates sleep onset and maintenance. This represents a novel mechanism distinct from traditional sedating antihistamines or benzodiazepines.
Approved indications
- Insomnia (sleep onset and sleep maintenance)
Common side effects
- Somnolence / next-day drowsiness
- Headache
- Dizziness
- Abnormal dreams / nightmares
- Sleep paralysis
Key clinical trials
- Trial of Suvorexant for Sleep in Children With Autism (PHASE2)
- Orexin s Role in the Neurobiology of Substance Use Disorder (NA)
- A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) (PHASE3)
- Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors (PHASE4)
- Measuring Acute Drug Demand in Humans (EARLY_PHASE1)
- The Effects of Orexin Antagonism on Fear Extinction in PTSD (PHASE4)
- Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms (PHASE1, PHASE2)
- Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Suvorexant (Belsomra) CI brief — competitive landscape report
- Suvorexant (Belsomra) updates RSS · CI watch RSS
- Massachusetts General Hospital portfolio CI