Clinical Trial

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

Active, Not Recruiting Early Phase 1
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-02-17; most recent amendment 2025-03-31.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-03-31
Trial Details
NCT Number NCT04273776
Lead Sponsor Walter Reed Army Institute of Research (WRAIR)
Conditions Performance Enhancing Product Use
Enrollment 90 participants
Start Date 2019-12-01
Primary Completion 2024-11-21 (estimated)
Study Completion 2025-12-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-03