NCT04273776

A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Walter Reed Army Institute of Research (WRAIR) · Federal
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Performance Enhancing Product Use

Interventions

Type	Name	Description
DRUG	Suvorexant 10 mg	10 mg of suvorexant
DRUG	Zolpidem	5 mg of zolpidem
DRUG	Placebos	Avicel

Timeline

• Start date: 2019-12-01
• Primary completion: 2024-11-21
• Completion: 2025-12-12
• First posted: 2020-02-18
• Last updated: 2025-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study