drugset / Trial / NCT03338764

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

NCT03338764

Phase 3 Withdrawn Sequential Medicine Ltd
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-05
Primary completion
2023-12
Completion
2023-12

Drugs

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

Indications