Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia (GEMS)

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 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)