MedTrace Logo

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

NCT04273776 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-04-03

No results posted yet for this study

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

DRUG

Suvorexant 10 mg

10 mg of suvorexant

DRUG

Zolpidem

5 mg of zolpidem

DRUG

Placebos

Avicel

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2024-11-21
Completion
2025-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04273776 on ClinicalTrials.gov