drugset / Trial / NCT02671760

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

NCT02671760

Phase 2 Completed 39 enrolled Sequential Medicine Ltd Clinilabs, Inc. · collab
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2016-02
Primary completion
2016-06
Completion
2016-06

Drugs

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

Indications