NCT02671760

Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia

A Randomized, Double-Blind, Single-Dose Study to Assess the Pharmacodynamic Effects of SM-1 Versus Comparator and Placebo in a 5 Hour Phase Advance Model of Insomnia in Adults Who Suffer From Short-Term Insomnia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Sequential Medicine Ltd · Industry
• Sex: All
• Age: 25 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of a combination drug product containing diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who do not have chronic insomnia. The study involves 3 one-night stays in a sleep center in New York City.

Detailed description

The purpose of this study is to evaluate the effect of a combination drug product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam on total sleep time, and to determine the contribution of diphenhydramine to the combination, using a 5-hour Phase Advance model of sleep challenge. This is a 3-arm cross-over study; each participant will receive 3 single-dose treatments on consecutive visits. The 3 arms are: investigational combination product, placebo, and a 2-drug comparator containing the zolpidem and lorazepam components but not diphenhydramine. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who are generally healthy and do not have chronic insomnia or sleep apnea. A total of 39 subjects are being recruited. Subjects who qualify for participation will be asked to keep a sleep diary to document their sleep times leading up to and during the study, and will be asked to spend 7-8 hours in bed at a regular bedtime during the study. Qualifying participants also will not anticipate significant disruptions in their sleep schedules, for example by traveling across timezones or changing shifts at work, during the study. The study requires 3 one-night stays in a sleep center in New York City, for administration of the study treatments and EEG measurements. Qualifying subjects will anticipate being able to return to the sleep center, located in Manhattan, for a total of 4 visits, including initial screening and 3 treatment times. During each sleep center visit, subjects will be given their study treatment and be put to bed 5 hours before their usual bedtime, and sleep time will be monitored for 8 hours. Each subject will receive all 3 treatments, although the sequence of the 3 treatments will be randomized. Both subjects and study personnel monitoring the subjects will be blinded to the identity of the treatment administered at each visit.

Conditions

• Short-term Insomnia

Interventions

Type	Name	Description
DRUG	SM-1	3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam
DRUG	Comparator	2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam
DRUG	Placebo	Placebo

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-02-02
• Last updated: 2018-03-06
• Results posted: 2018-03-06