drugset / Trial / NCT04396327

SM-1 vs. an Active Comparator in A Model of Transient Insomnia

NCT04396327

Phase 2 Not yet recruiting 14 enrolled Sequential Medicine Ltd
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or a combination of diphenhydramine and lorazepam during 2 one-night stays at a sleep center.

Timeline

Start
2020-05-27
Primary completion
2020-06-30
Completion
2020-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Zolpidem Small molecule 5 mg
Background Diphenhydramine Unknown 50 mg
Background Lorazepam Small molecule 0.5 mg

Indications