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An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia

Transient Insomnia Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled, Parallel Design Phase 3 Study to Assess the Efficacy, Safety, Tolerability, and Pattern of Use of SM-1 in Adult Subjects With a History of Transient Insomnia

Clinical Trial Summary

The purpose of this study is to assess the efficacy and pattern of use of the combination drug product SM-1 in adults who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or placebo to take at home as needed over the course of 3 months treatment period.

Clinical Trial Description

The purpose of this study is to assess the efficacy, safety, tolerability and pattern of use of SM-1 in adults who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. SM-1 is a combination drug product containing diphenhydramine, zolpidem and lorazepam. The study is a parallel group design; participants will receive either SM-1 or placebo to take at home as needed over the course of 3 months treatment period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03338764
Study type Interventional
Source Sequential Medicine Ltd
Contact
Status Withdrawn
Phase Phase 3
Start date May 2023
Completion date December 2023
View Details
See also
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Completed NCT01779830 - A Study of LY2624803 in Participants With Transient Insomnia Phase 1
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Completed NCT00671398 - Efficacy of Ramelteon on Transient Insomnia in Healthy Adults Phase 3
Completed NCT00659100 - A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment Phase 3