~10 spots leftby Dec 2025

Sleep Medications for Healthy Volunteers

Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: Walter Reed Army Institute of Research (WRAIR)

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.

Eligibility Criteria

Healthy English-speaking adults aged 18-39 can join this trial. Women must use birth control if sexually active. Excluded are those with irregular sleep schedules, depression, kidney/liver disease, heavy alcohol/drug use, certain medical conditions or extreme morning/evening preferences.

Inclusion Criteria

I am using birth control.
Volunteers must have learned English as their first language
I am a healthy adult between 18 and 39 years old and not pregnant or breastfeeding.

Exclusion Criteria

Inability to read and sign consent
Incarceration during Phase 1
I have liver disease or significant liver problems.
See 31 more

Treatment Details

Interventions

  • Placebos (Other)
  • Suvorexant (Dual Orexin Receptor Antagonist)
  • Zolpidem (GABA A agonist)
Trial OverviewThe study tests Suvorexant (10 mg) and Zolpidem against a placebo to see which is better for sleep induction without affecting performance. It's randomized and double-blind, meaning participants and researchers don't know who gets which treatment.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: Zolpidem ArmActive Control2 Interventions
5 mg of Zolpidem
Group II: Suvorexant ArmActive Control2 Interventions
10 mg of Suvorexant
Group III: PlaceboPlacebo Group1 Intervention
10mg of Avicel

Suvorexant is already approved in United States, Australia, Japan for the following indications:

πŸ‡ΊπŸ‡Έ Approved in United States as Belsomra for:
  • Insomnia characterized by difficulties with sleep onset and/or sleep maintenance
πŸ‡¦πŸ‡Ί Approved in Australia as Belsomra for:
  • Insomnia characterized by difficulties with sleep onset and/or sleep maintenance
πŸ‡―πŸ‡΅ Approved in Japan as Belsomra for:
  • Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Walter Reed Army Institute of ResearchSilver Spring, MD
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Who Is Running the Clinical Trial?

Walter Reed Army Institute of Research (WRAIR)Lead Sponsor

References