SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.

Transient Insomnia Clinical Trial

Official title:
A Randomized, Double-Blind, Single-Dose, 4-Way Crossover Study to Assess the Efficacy and Safety of SM-1 (50-mg Diphenhydramine, 5-mg Delayed-Release Zolpidem, and 0.5-mg Delayed-Release Lorazepam) Versus 2 Comparators (50-mg Diphenhydramine and 5-mg Delayed-Release Zolpidem; 50-mg Diphenhydramine and 0.5-mg Delayed-Release Lorazepam) and Placebo in a 5-Hour Phase Advance Model of Transient Insomnia.

Status Completed

Clinical Trial 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 zolpidem, or a combination of diphenhydramine and lorazepam, or placebo during 4 one-night stays at a sleep center.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Sleep Initiation and Maintenance Disorders
Transient Insomnia

Clinical Trial Details

NCT number	NCT03331042
Study type	Interventional
Source	Sequential Medicine Ltd
Contact
Status	Completed
Phase	Phase 3
Start date	October 9, 2017
Completion date	March 22, 2018

View Details

See also
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