Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration

The purpose of this study is to evaluate the effect of a 3 month medication trial of Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic insomnia.

Participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT, with a 6 month follow up. The primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. The secondary outcome measure will be subjective severity of sleep disturbance.

Inclusion Criteria:

• Chronic insomnia with duration of more than 1 year
• Objective short sleep duration (< 6 hours)
• BMI < 39
• Ages 30-60
• Men & Women

Exclusion Criteria:

• Major Mental Illness
• Substance Abuse/Dependence
• Sleep Apnea
• Periodic Limb Movement Disorder
• Shift Work or circadian disorders
• Diabetes
• Chronic Renal Failure, Hepatic Insufficiency, Chronic Heart Failure
• Current Use of hypnotics or sleep inducing sedative antidepressants