NCT03338764

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sequential Medicine Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Transient Insomnia

Interventions

Type	Name	Description
DRUG	SM-1	SM-1 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam self-administered as needed to promote sleep
DRUG	Placebo	Identical in appearance to SM-1 and has the same excipients, but no active ingredients or delayed-release coating materials, self-administered as needed to promote sleep

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2017-11-09
• Last updated: 2024-04-17

Regulatory

• FDA-regulated drug study