Safety and Efficacy Study of APD125 in Patient With Insomnia

A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia

The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.

Inclusion Criteria:

• Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
• PSQI >/= to 5
• Qualifying screening PSG parameters
• Generally good health

Exclusion Criteria:

• History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
• Any clinically significant medical condition, laboratory finding, or ECG finding
• Pregnant and/or lactating females
• History of substance abuse within 2 years or positive urine drug screen
• Positive Hepatitis B/C results or HIV markers
• Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) > 10 as determined by screening PSG
• History of treatment with an investigational drug within the last month
• Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (> 3 time zones) during the study