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

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