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Cognitive Behavioral Therapy vs Zopiclone for Treatment of Chronic Primary Insomnia in Older Adults
A Randomized Controlled Trial
Børge Sivertsen, PsyD;
Siri Omvik, PsyD;
Ståle Pallesen, PhD;
Bjørn Bjorvatn, MD, PhD;
Odd E. Havik, PhD;
Gerd Kvale, PhD;
Geir Høstmark Nielsen, PsyD;
Inger Hilde Nordhus, PhD
JAMA. 2006;295:2851-2858.
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.
Trial Registration clinicaltrials.gov Identifier: NCT00295386
Author Affiliations: Department of Clinical Psychology (Drs Sivertsen, Omvik, Havik, Kvale, Nielsen, and Nordhus); Department of Psychosocial Science (Dr Pallesen); Norwegian Competence Center for Sleep Disorders (Drs Bjorvatn, Pallesen, and Nordhus); and Department of Public Health and Primary Health Care (Dr Bjorvatn), University of Bergen, Bergen, Norway.
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