Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness

Exclusion Criteria

• •Clinically significant or unstable medical condition that may interfere with sleep
• •Major psychiatric disorders (other than insomnia) such as depression, schizophrenia, bipolar disorder
• •History of myocardial infarction, cardiac failure or clinically significant dysrhythmias in the previous 2 years or clinically significant ECG abnormalities at screening
• •History of substance abuse
• •Disorders that interfere with drug pharmacokinetics
• •History of cancer, except basal cell carcinoma
• •Use of hypnotics, anxiolytics, antidepressants, anticonvulsants, over-the-counter sleep aids, histamine-1 receptor antagonists (except for loratadine and fexofenadine), beta-adrenergic blockers (except for atenolol), respiratory stimulants and decongestants, systemic steroids, narcotic analgesics, any other compound which might impact sleep-wake function, or medication used for the treatment of Parkinson's disease such as dopamine agonists and L-dopa (e.g., Sinemet, Madopar or Requip)
• •Use of hypnotics within the 2 weeks preceding the Screening Period or within five half-lives of the medication, whichever is longer
• •Consuming ≥ 350 mg per day of xanthine-containing food or beverages
• •Smoking ≥ 10 cigarettes per day and/or unable to refrain from smoking without distress or discomfort for the duration of visits to the sleep laboratory (i.e.≥ 20 hours)
• •Body mass index \> 34 kg/m2;
• •Performing night work or rotating shift work during the past month
• •Traveling across \> 3 time zones in the past 2 weeks
• •Participation in another trial of an investigational product or device within the previous 30 days
• •Known allergy or sensitivity to benzodiazepines