Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia

Exclusion Criteria

• •Females who are lactating or who are pregnant, or of childbearing potential not using an acceptable form of contraception
• •Patients presenting with acute or chronic pain resulting in insomnia
• •Patients with current psychiatric disturbances
• •Body mass index \> 32
• •Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety
• •Clinically significant and abnormal electrocardiogram (ECG) (including QTc B \> 500ms),
• •A positive test for hepatitis B (hepatitis B surface \[HBs\] antigens) or C (hepatitis C virus \[HCV\] antibodies)
• •Positive qualitative urine drug screen at screening
• •Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day
• •Use of any over-the-counter or prescription sleep medication, or of any substance with psychotropic effects or properties known to affect sleep/wake, within one week or five half-lives (whichever is longer), prior to screening
• •Night shift workers, and individuals who nap 3 or more times per week over the preceding month
• •Based on medical history and/or NPSG:
• •* primary hypersomnia
• •* narcolepsy
• •* breathing-related sleep disorder (apnea-hypopnea index \> 10/hour of sleep)
• •* circadian rhythm sleep disorder
• •* parasomnia (e.g. somnambulism)