Trial Information

Summary: If you experience difficulty Initiating Sleep, Maintaining Sleep or Nonrestorative sleep we are conducting a Double-Blind, Randomized, Multicenter, Placebo-Controlled, Efficacy and Safety Study in the Treatment of Adult Outpatients With Primary Insomnia.

The purpose of this research study is to test to see if the study medication taken at bedtime is better than placebo in improving your sleeping disorder. You will be paid $50.00 per study visit for a total of up to $950.00. There is a total of 19 visits (1x/wk to Visit 5, then approx. 1x/mo) The duration of the study is 12 months.

Inclusion Criteria:

• Male or Female, 18-64 y/o.
• Able to operate an Electronic Diary.
• Limit your alcohol to 2 drinks/day.
• Limit caffeine consumption to less than 5 cups/day.
• Normal Urine Drug Screen.

Exclusion Criteria:

• Lactose Intolerance.
• History of Bipolar or Schizophrenia.
• Narcolepsy, nightmare, sleep terror, sleepwalking.
• History of Hepatitis.
• Sleep Apnea.

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Trial listings updated: June 1, 2008 at 5:44:30 AM