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

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

Study Overview

• Status: Completed
• Conditions: Occasional Sleeplessness
• Intervention / Treatment: Drug: Diphenhydramine Hydrochloride; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• be male or female subjects, ≥18 years of age to 55 years of age, who report that they are currently experiencing occasional sleeplessness characterized by difficulty initiating sleep (ie, taking ≥30 minutes to fall asleep) on average 2-4 times per week for less than 1 month;
• be in good general health without clinically significant disease (no previously diagnosed sleep disorders);
• if female, have a negative screening pregnancy test and agree to be on approved methods of birth control throughout the study

Exclusion Criteria:

• have a clinically significant illness within 30 days of Screening;
• are taking medication that could interfere with the study medication;
• have been under a clinician's care for insomnia treatment and control within the past year or has a history of insomnia or is currently taking prescription medications for insomnia;
• are currently taking medications known to effect sleep function;
• have current or past history of serious, severe or unstable physical or psychiatric illness;
• have current diagnosis of severe urinary retention;
• have current diagnosis of untreated narrow angle glaucoma;
• had participated in a clinical drug study or used an investigational new drug during the previous 30 days;
• have any clinically significant or abnormal finding in physical examination, vital signs, ECG, or clinical laboratory tests that may affect the subject's safety or outcome of the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diphenhydramine Hydrochloride; Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep	Drug: Diphenhydramine Hydrochloride; 30 mL at bedtime; Other Names: Zzzquil
Placebo Comparator: Placebo; Placebo elixir taken when subjects had trouble falling asleep	Drug: Placebo; 30 mL at bedtime; Other Names: placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Latency to Persistent Sleep	Per Protocol population based on subjects who completed treatment crossover	4 weeks

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine
• Other Study ID Numbers: 2013063