Behavioral and pharmacological therapies for late-life insomnia - A randomized controlled trial

Context Insomnia is a prevalent health complaint in older adults. Behaviora l and pharmacological treatments have their benefits and limitations, but n o placebo-controlled study has compared their separate and combined effects for late-life insomnia. Objective To evaluate the clinical efficacy of behavioral and pharmacologic al therapies, singly and combined, for late-life insomnia. Design and Setting Randomized, placebo-controlled clinical trial, at a sing le 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 c hronic and primary insomnia. Interventions Cognitive-behavior therapy (stimulus control, sleep restricti on, sleep hygiene, and cognitive therapy) (n = 18), pharmacotherapy (temaze pam) (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 subjec ts, significant others, and clinicians. Results The 3 active treatments were more effective than placebo at posttre atment assessment; there was a trend for the combined approach to improve s leep more than either of its 2 single components (shorter time awake after sleep onset by sleep diary and polysomnography). For example, the percentag e reductions of time awake after sleep onset was highest for the combined c ondition (63.5 %), followed by cognitive-behavior therapy (55%), pharmacoth erapy (46.5%), and placebo (16.9%). Subjects treated with behavior therapy sustained their clinical gains at follow-up, whereas those treated with dru g therapy alone did not. Long-term outcome of the combined intervention was more variable. Behavioral treatment, singly or combined, was rated by subj ects, significant others, and clinicians as more effective than drug therap y alone. Subjects were also more satisfied with the behavioral approach. Conclusions Behavioral and pharmacological approaches are effective for the shortterm management of insomnia in late life; sleep improvements are bett er sustained over time with behavioral treatment.