NCT03331042

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Sequential Medicine Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transient Insomnia

Interventions

Type	Name	Description
DRUG	SM-1	3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.
DRUG	D+Z	2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.
DRUG	D+L	2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.
DRUG	Placebo	Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.

Timeline

• Start date: 2017-10-09
• Primary completion: 2018-03-20
• Completion: 2018-03-22
• First posted: 2017-11-06
• Last updated: 2019-06-05
• Results posted: 2019-06-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study