Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

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;