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Cognitive Behavior Therapy and Pharmacotherapy for Insomnia
A Randomized Controlled Trial and Direct Comparison
Gregg D. Jacobs, PhD;
Edward F. Pace-Schott, MA;
Robert Stickgold, PhD;
Michael W. Otto, PhD
Arch Intern Med. 2004;164:1888-1896.
Background Chronic sleep-onset insomnia is a prevalent health complaint in adults. Although behavioral and pharmacological therapies have been shown to be effective for insomnia, no placebo-controlled trials have evaluated their separate and combined effects for sleep-onset insomnia. The objective of this study was to evaluate the clinical efficacy of behavioral and pharmacological therapy, singly and in combination, for chronic sleep-onset insomnia.
Methods This was a randomized, placebo-controlled clinical trial that involved 63 young and middle-aged adults with chronic sleep-onset insomnia. Interventions included cognitive behavior therapy (CBT), pharmacotherapy, or combination therapy compared with placebo. The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning.
Results In most measures, CBT was the most sleep effective intervention; it produced the greatest changes in sleep-onset latency and sleep efficiency, yielded the largest number of normal sleepers after treatment, and maintained therapeutic gains at long-term follow-up. The combined treatment provided no advantage over CBT alone, whereas pharmacotherapy produced only moderate improvements during drug administration and returned measures toward baseline after drug use discontinuation.
Conclusions These findings suggest that young and middle-age patients with sleep-onset insomnia can derive significantly greater benefit from CBT than pharmacotherapy and that CBT should be considered a first-line intervention for chronic insomnia. Increased recognition of the efficacy of CBT and more widespread recommendations for its use could improve the quality of life of a large numbers of patients with insomnia.
From the Sleep Disorders Center, Beth Israel Deaconess Medical Center (Dr Jacobs), Laboratory of Neurophysiology, Harvard Medical School (Drs Jacobs and Stickgold and Mr Pace-Schott), and Massachusetts General Hospital and Harvard Medical School (Dr Otto), Boston, Mass; and Mind/Body Medical Institute, Chestnut Hill, Mass (Dr Jacobs). Dr Otto has served as a consultant for Pfizer Inc, Janssen Pharmaceutica Products, and Wyeth, and receives research support from GlaxoSmithKline, Pfizer, and Eli Lilly and Company.
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