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ACTIVE NOT RECRUITING
NCT04273776
EARLY_PHASE1

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

Sponsor: Walter Reed Army Institute of Research (WRAIR)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2019-12-01

Completion Date

2025-12-12

Last Updated

2025-04-03

Healthy Volunteers

Yes

Interventions

DRUG

Suvorexant 10 mg

10 mg of suvorexant

DRUG

Zolpidem

5 mg of zolpidem

DRUG

Placebos

Avicel

Locations (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, United States