Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

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;