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

NCT04273776 EARLY_PHASE1 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsorWalter Reed Army Institute of Research (WRAIR)
PhaseEARLY_PHASE1
StatusACTIVE_NOT_RECRUITING
Enrolment90
Start dateSun Dec 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionFri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States