A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study
Overview
- Phase
- Early Phase 1
- Intervention
- Suvorexant 10 mg
- Conditions
- Performance Enhancing Product Use
- Sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- consolidation of episodic memory
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Suvorexant Arm
10 mg of Suvorexant
Intervention: Suvorexant 10 mg
Suvorexant Arm
10 mg of Suvorexant
Intervention: Placebos
Zolpidem Arm
5 mg of Zolpidem
Intervention: Zolpidem
Zolpidem Arm
5 mg of Zolpidem
Intervention: Placebos
Placebo
10mg of Avicel
Intervention: Placebos
Outcomes
Primary Outcomes
consolidation of episodic memory
Time Frame: 5 days
presentation of word lists
psychomotor vigilance test
Time Frame: 4 days
measures reaction time