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

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.

Timeline

Start

2017-10-09

Primary completion

2018-03-20

Completion

2018-03-22

Drugs

Indications