Safety and Efficacy Study of APD125 in Patient With 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