Combined Behavioral/Pharmacological Therapy for Insomnia

This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

Long-term insomnia is a common and significant health problem. Two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia.

During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires.

Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone. During treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires.

After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study.

After the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.

• Behavioral: Cognitive-Behavioral Therapy for Insomnia
• Drug: zolpidem tartrate (Ambien)

Inclusion Criteria:

• Chronic primary insomnia which includes at least 6 months of trouble falling asleep or staying asleep