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Dose-matched Placebo to Suvorexant
This is a placebo control formulation matched to suvorexant, an orexin receptor antagonist used to promote sleep.
This is a placebo control formulation matched to suvorexant, an orexin receptor antagonist used to promote sleep. Used for Insomnia (sleep onset and/or sleep maintenance) — placebo control in phase 3 trials.
At a glance
| Generic name | Dose-matched Placebo to Suvorexant |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Orexin receptor antagonist |
| Target | OX1R and OX2R (orexin receptors) |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | Phase 3 |
Mechanism of action
Suvorexant works by blocking orexin receptors (OX1R and OX2R) in the brain, which suppresses wakefulness-promoting signals and facilitates sleep onset and maintenance. The dose-matched placebo is an inert formulation designed to match the active drug in appearance and administration for blinded clinical trial comparison.
Approved indications
- Insomnia (sleep onset and/or sleep maintenance) — placebo control in phase 3 trials
Common side effects
- Somnolence
- Headache
- Dizziness
Key clinical trials
- Trial of Suvorexant for Sleep in Children With Autism (PHASE2)
- Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors (PHASE4)
- Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085) (PHASE3)
- Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061) (PHASE3)
- Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users (PHASE1)
- Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029) (PHASE3)
- Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006) (PHASE2)
- A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3) (PHASE3)
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:
- Dose-matched Placebo to Suvorexant CI brief — competitive landscape report
- Dose-matched Placebo to Suvorexant updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI