Morin · JAMA 1999 · randomized placebo-controlled trial · n=78

Behavioral and pharmacological therapies for late-life insomnia: a randomized controlled trial.

Cited 1108 times in the scientific literature.

Level 2 - randomized trial

Individual randomized placebo-controlled trial

PubMed 10086433 · doi:10.1001/jama.281.11.991 · record verified 2026-08-31

What was done

Seventy-eight older adults (50 women, 28 men; mean age 65 years) with chronic, primary insomnia were randomized at a single academic medical center to 8 weeks of outpatient treatment in one of four groups: cognitive-behavior therapy (CBT including stimulus control, sleep restriction, sleep hygiene, and cognitive therapy; n = 18), pharmacotherapy (temazepam; n = 20), combined CBT and temazepam (n = 20), or placebo (n = 20). Outcomes were assessed at posttreatment and at 3, 12, and 24 months using sleep diaries and polysomnography (time awake after sleep onset and sleep efficiency) alongside clinical ratings from subjects, significant others, and clinicians.

What was found

All three active treatments were more effective than placebo at 8 weeks. Percentage reductions in time awake after sleep onset were 63.5% for combined therapy, 55% for CBT, 46.5% for temazepam, and 16.9% for placebo, with a trend favoring the combined approach short term. At follow-up (3, 12, and 24 months), patients receiving CBT sustained their clinical gains, while those receiving temazepam alone did not; outcomes in the combined arm were more variable. Behavioral treatment (alone or combined) was rated by subjects, significant others, and clinicians as more effective than drug therapy alone, and subjects reported greater satisfaction with behavioral approaches.

Why it matters

This trial shows that while both behavioral and pharmacological interventions relieve late-life insomnia in the short term, behavioral therapy provides durable long-term benefit whereas pharmacotherapy alone does not sustain improvements after discontinuation.

Limits

The study had a relatively small sample size (18–20 per group) at a single center. The abstract does not report exact numerical values or confidence intervals for polysomnography metrics or the 3-, 12-, and 24-month follow-up time points.

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