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drugset / Trial / NCT04273776

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

NCT04273776 ↗

Phase 0 Active not recruiting 90 enrolled Walter Reed Army Institute of Research (WRAIR)
RandomizedSingle-groupDouble-blindOther

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.

Timeline

Start
2019-12-01
Primary completion
2024-11-21
Completion
2025-12-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Suvorexant Small molecule 10 mg —
Comparator Zolpidem Small molecule 5 mg —

Indications

No indication recorded.