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A Randomized Controlled Trial

Charles M. Morin, PhD; Cheryl Colecchi, PhD; Jackie Stone, PhD; Rakesh Sood, MD; Douglas Brink, PharmD

JAMA. 1999;281:991-999.

Context  Insomnia is a prevalent health complaint in older adults. Behavioral and pharmacological treatments have their benefits and limitations, but no placebo-controlled study has compared their separate and combined effects for late-life insomnia.

Objective  To evaluate the clinical efficacy of behavioral and pharmacological therapies, singly and combined, for late-life insomnia.

Design and Setting  Randomized, placebo-controlled clinical trial, at a single academic medical center. Outpatient treatment lasted 8 weeks with follow-ups conducted at 3, 12, and 24 months.

Subjects  Seventy-eight adults (50 women, 28 men; mean age, 65 years) with chronic and primary insomnia.

Interventions  Cognitive-behavior therapy (stimulus control, sleep restriction, sleep hygiene, and cognitive therapy) (n=18), pharmacotherapy (temazepam) (n=20), or both (n=20) compared with placebo (n=20).

Main Outcome Measures  Time awake after sleep onset and sleep efficiency as measured by sleep diaries and polysomnography; clinical ratings from subjects, significant others, and clinicians.

Results  The 3 active treatments were more effective than placebo at posttreatment assessment; there was a trend for the combined approach to improve sleep more than either of its 2 single components (shorter time awake after sleep onset by sleep diary and polysomnography). For example, the percentage reductions of time awake after sleep onset was highest for the combined condition (63.5%), followed by cognitive-behavior therapy (55%), pharmacotherapy (46.5%), and placebo (16.9%). Subjects treated with behavior therapy sustained their clinical gains at follow-up, whereas those treated with drug therapy alone did not. Long-term outcome of the combined intervention was more variable. Behavioral treatment, singly or combined, was rated by subjects, significant others, and clinicians as more effective than drug therapy alone. Subjects were also more satisfied with the behavioral approach.

Conclusions  Behavioral and pharmacological approaches are effective for the short-term management of insomnia in late life; sleep improvements are better sustained over time with behavioral treatment.

Author Affiliations: Université Laval, Sainte-Foy, Québec (Dr Morin); and Medical College of Virginia/Virginia Commonwealth University, Richmond (Drs Morin, Colecchi, Stone, Sood, and Brink).

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