A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study
- Conditions
- Performance Enhancing Product Use
- Interventions
- Registration Number
- NCT04273776
- Lead Sponsor
- Walter Reed Army Institute of Research (WRAIR)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Suvorexant Arm Suvorexant 10 mg 10 mg of Suvorexant Suvorexant Arm Placebos 10 mg of Suvorexant Zolpidem Arm Zolpidem 5 mg of Zolpidem Zolpidem Arm Placebos 5 mg of Zolpidem Placebo Placebos 10mg of Avicel
- Primary Outcome Measures
Name Time Method consolidation of episodic memory 5 days presentation of word lists
psychomotor vigilance test 4 days measures reaction time
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Walter Reed Army Institute of Research
🇺🇸Silver Spring, Maryland, United States