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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

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 12, 2025 to Nov 21, 2024
    v7
  2. Primary and study completion dates: Nov 13, 2023 to Dec 12, 2025v6
  3. Primary completion date: Nov 13, 2022 to Nov 13, 2023v5
  4. 3 versions Re-verified since Apr 5, 2021, no change to tracked fieldsv2-v4
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04273776
Lead Sponsor Walter Reed Army Institute of Research (WRAIR)
Conditions
(from sponsor)		 Performance Enhancing Product Use
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov