NCT02578186

Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

Randomized, Double-Blind, Placebo-Controlled, Crossover, In-home Study to Assess the Efficacy of Diphenhydramine Hydrochloride in Subjects With Occasional Sleeplessness

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

Detailed description

Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by the Food \& Drug Administration to reduce the time to sleep onset in individuals having difficulty falling asleep. The goal of the study is to investigate diphenhydramine versus placebo with regard to several sleep parameters, including time to sleep onset, in healthy adult subjects suffering from occasional sleeplessness.

Conditions

• Occasional Sleeplessness

Interventions

Type	Name	Description
DRUG	Diphenhydramine Hydrochloride	30 mL at bedtime
DRUG	Placebo	30 mL at bedtime

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2015-10-16
• Last updated: 2017-03-15
• Results posted: 2017-03-15