Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year

The study is being conducted worldwide.

It consists of 4 segments:

• Segment A: 7-day run-in (screening)
• Segment B: 12-week double blind treatment
• Segment C: 40-week open treatment extension
• Segment D: 2-week run-out period

Inclusion criteria

• Out patients
• Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I criteria
• Based on patient's information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks.
• Based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
• Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.

Exclusion criteria

• Females who are lactating or pregnant
• Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
• Patients presenting with acute or chronic pain resulting in insomnia
• Patients with history of epilepsy or seizures
• Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day
• Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
• BMI >32
• Acute or chronic pain resulting in insomnia
• Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia
• Clinically significant and abnormal EKG (QTc interval >500 msec)
• Positive for hepatitis B or C
• Serious head injury or stroke within 1 year
• Use of OTC medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
• Participation in another trial within two month before the screening visit
• Use of any substance with psychotropic effects or properties known to affect sleep/wake
• Unable to complete the study questionnaires
• Night shift workers, and individuals who nap 3 or more times per week over the preceding month
• History of:

• Primary hypersomnia
• Narcolepsy
• Breathing-related sleep disorder (such as sleep apnea)
• Circadian rhythm sleep disorder
• Parasomnia (somnambulism)
• Dyssomnia (such as periodic leg movements)