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Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02578186
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Information provided by (Responsible Party):
Procter and Gamble

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

Condition or disease Intervention/treatment Phase
Occasional Sleeplessness Drug: Diphenhydramine Hydrochloride Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Crossover, In-home Study to Assess the Efficacy of Diphenhydramine Hydrochloride in Subjects With Occasional Sleeplessness
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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 Name: Zzzquil

Placebo Comparator: Placebo
Placebo elixir taken when subjects had trouble falling asleep
Drug: Placebo
30 mL at bedtime
Other Name: placebo comparator

Primary Outcome Measures :
  1. Mean Latency to Persistent Sleep [ Time Frame: 4 weeks ]
    Per Protocol population based on subjects who completed treatment crossover

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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;
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Responsible Party: Procter and Gamble Identifier: NCT02578186    
Other Study ID Numbers: 2013063
First Posted: October 16, 2015    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Dermatologic Agents