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