Trial Information

Summary: Phase II Double-Blind Placebo Insomnia Study.

We are looking for subjects in two different age groups. Protocol 1 is for ages 18-65 and protocol 2 is for 65-80.

You must have the diagnosis of insomnia. No psychiatric history, clinical depression or any other sleep related disorders. You must have the ability to keep a palm pilot for the sponsor which will be provided for the study.

We are testing a sleep aid medication that is currently not approved by the FDA. If you are currently taking any sleep aides you have a washout period which you will come off of those drugs for the duration of the study.

You must be able to spend 10 nights in our sleep center spaced out over a 38-day period. We will be accepting applicants for 1 year. You will have a complete neurological physical, blood test, EKG performed and a drug screening. You must be able to refrain from the excessive use of caffeine during the trial. You will be compensated for your time.

Study Criteria

• Must be in good physical and mental health.
• Willing to limit alcohol consumption to two drinks per day.
• Limit caffeine to less than 5 six ounce cups per day.
• If, female and of childbearing age be willing to use birth control, two methods.
• Be willing to have a regular bedtime for the duration of the study.
• Refrain from napping for more than one hour per day.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.