Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

Procter & Gamble (P&G)

Status and phase

Completed

Phase 4

Conditions

Occasional Sleeplessness

Treatments

Drug: Placebo

Drug: Diphenhydramine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT02578186

2013063

Details and patient eligibility

About

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

Full 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.

Enrollment

33 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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;