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.

Research Team

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.

Treatment Details

Interventions

• Placebos (Other)
• Suvorexant (Dual Orexin Receptor Antagonist)
• Zolpidem (GABA A agonist)

Trial Overview The 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

Group I: Zolpidem Arm Active Control 2 Interventions

5 mg of Zolpidem

Group II: Suvorexant Arm Active Control 2 Interventions

10 mg of Suvorexant

Group III: Placebo Placebo Group 1 Intervention

10mg of Avicel

Suvorexant is already approved in Japan for the following indications:

Approved in Japan as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Who Is Running the Clinical Trial?

Walter Reed Army Institute of Research (WRAIR)

Lead Sponsor

Trials

111

Recruited

108,000+

Colonel Eli Lozano

Walter Reed Army Institute of Research (WRAIR)

Chief Executive Officer since 2023

BSc from United States Military Academy at West Point, Master's in Health Care Administration from Baylor University, Master's in Strategic Studies from U.S. Air War College

Dr. Deborah Shear

Walter Reed Army Institute of Research (WRAIR)

Chief Medical Officer since 2023

MD from Uniformed Services University of the Health Sciences