Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia

12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of
run-out (placebo)

Total Duration of observation: 15 weeks for each patient

Inclusion Criteria:

- Out patients

- Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I
(Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition-Text Revision)
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 (over-the-counter) 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)