Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia

The purpose of this research study is to investigate the effectiveness and safety of 2 doses of the investigational product in subjects with sleep disorders with fibromyalgia as compared to placebo (a substance which contains no active ingredient). The study will last approximately 70 days and will include 7 office visits.

Inclusion criteria

• Each patient must fulfill the diagnosis criteria of fibromyalgia according to the American College of Rheumatology
• Based on patient's information:
• The patient must complain of unrefreshing sleep for at least 3 nights per week over the past month.
• The patient spends at least 6.5 hours and not more than 9 hours, in bed, each night over the past 2 weeks.
• Female patients of childbearing potential must have a confirmed negative pregnancy test at the end of the screening period and use an acceptable method of birth control throughout the study
• Written, signed and dated informed consent must be obtained from each patient
• Willing to abstain from taking any medication or treatment prohibited as per the protocol

Exclusion criteria

• Females who are lactating or pregnant
• Night shift workers, and individuals who nap 3 or more times per week over the preceding month (nap: intentionally sleeping for more than 20 minutes during the day).
• Consumption of beverage with caffeine (i.e. tea, coffee, or cola) comprising more than 2 cups or glasses per day
• Past or Current medical history of any significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety