Trial Information

Summary: A Phase IIB study to test the efficacy and safety of multiple dosing regimen of an investigational drug in the treatment of sleep maintenance insomnia.

Inclusion Criteria:

• Males or female patient, 50 years or older.
• Patient with primary insomnia, with predominant complaints of impaired sleep maintenance, and a subject-reported history of more than 1 hour of wakefulness after sleep onset during desired sleep time, four or more nights per week for at least one month.
• Patient reported impact of insomnia should meet certain level of severity.
• Female patients must be of non-child bearing potential (defined as post-menopausal or surgically sterile).
• Patient weight should be within certain limits.
• Patient must have a habitual bedtime between 9:00 PM and midnight, and self-reported time in bed must be between 6 to 9 hours.
• Adult patient must not be under guardianship and without restriction of freedom by administrative or legal decisions.

Exclusion Criteria:

• Certain psychiatric disorders.
• History of stroke or severe head trauma (involving loss of consciousness or requiring hospitalization).
• Screening Day patient-reported latency to sleep onset of more than 60 minutes.
• Screening Night total sleep time less than 4 hours.
• Napping of more than 45 minutes per day.
• History of drug or alcohol abuse within two years of the start of the study.
• History of sleep apnea with certain apnea/hypo-apnea index umber.
• Primary sleep disorders including restless leg syndrome, narcolepsy, and REM behavior disorder.
• Smokers unable to refrain from smoking in the overnight period.
• Poorly controlled diabetes.
• Cardiac surgery within the past year, unstable angina and significant ECG abnormality.
• Currently being treated with certain drugs.
• Being treated with any investigational product within 4 weeks prior to screening visit.
• Erratic sleep/wake schedules and change in the level of daily activities or in life style, such as stopping cigarette smoking within the past 30 days.
• Drinking more than 3 glasses (120 ml) of wine (or equivalent) per day.
• Drinking more than 5 cups of coffee (or tea) per day.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.