Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Occasional Sleeplessness

Intervention / Treatment
-----------------
* Drug: Diphenhydramine Hydrochloride
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diphenhydramine Hydrochloride<br>Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep | Drug: Diphenhydramine Hydrochloride<br>* 30 mL at bedtime<br>* Other names: Zzzquil;|
| Placebo Comparator: Placebo<br>Placebo elixir taken when subjects had trouble falling asleep | Drug: Placebo<br>* 30 mL at bedtime<br>* 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 |