Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults - A randomized controlled trial

Context Insomnia is a common condition in older adults and is associated with a number of adverse medical, social, and psychological consequences. Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments, but blinded placebo-controlled trials comparing the effects of these treatments are lacking. Objective To examine short- and long-term clinical efficacy of cognitive behavioral therapy (CBT) and pharmacological treatment in older adults experiencing chronic primary insomnia. Design, Setting, and Participants A randomized, double-blinded, placebo-controlled trial of 46 adults ( mean age, 60.8 y; 22 women) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients. Intervention CBT ( sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relaxation; n=18), sleep medication (7.5-mg zopiclone each night; n=16), or placebo medication (n=12). All treatment duration was 6 weeks, and the 2 active treatments were followed up at 6 months. Main Outcome Measures Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time, total sleep time, sleep efficiency, and slow-wave sleep ( only assessed using polysomnography) on all 3 assessment points. Results CBT resulted in improved short- and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures. For most outcomes, zopiclone did not differ from placebo. Participants receiving CBT improved their sleep efficiency from 81.4% at pretreatment to 90.1% at 6-month follow-up compared with a decrease from 82.3% to 81.9% in the zopiclone group. Participants in the CBT group spent much more time in slow-wave sleep ( stages 3 and 4) compared with those in other groups, and spent less time awake during the night. Total sleep time was similar in all 3 groups; at 6 months, patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone. Conclusion These results suggest that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults.