Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

Inclusion Criteria:

• Subjects between the ages of 18 and 65 years of age
• Subjects that meet DSM IV diagnostic criteria for Insomnia
• Subjects that report a time in bed NLT 6.5 and NMT 9 hours
• Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
• Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep >1.0 hour
• Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset
• On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
• On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
• On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights

Exclusion Criteria:

• Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
• Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
• Subject with a history (past year) of alcohol or substance abuse
• Subject that needs to smoke during the sleep period time
• Subject that reports habitual napping (more than 3 times per week)