Cited by 589Sleep and related disordersObstructive Sleep Apnea ResearchAnxiety, Depression, Psychometrics, Treatment, Cognitive Processes

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Cognitive Behavioral Therapy vs Zopiclone for Treatment of Chronic Primary Insomnia in Older Adults: A Randomized Controlled Trial

Sivertsen, Børge, Omvik, Siri, Pallesen, Ståle, Bjorvatn, Bjørn, Havik, Odd E., Kvale, Gerd, Nielsen, Geir Høstmark, Nordhus, Inger Hilde·2006·JAMA

DOI 10.1001/jama.295.24.2851

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Abstract

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.

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Background
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Authors: Sivertsen, B., Omvik, S., Pallesen, S., Bjorvatn, B., Havik, O. E., Kvale, G., Nielsen, G. H., & Nordhus, I. H.
Affiliations: University of Bergen (NO)
Corresponding author: Sivertsen, Børge
ORCID: Sivertsen, Børge
Omvik, Siri
Pallesen, Ståle
Bjorvatn, Bjørn
Kvale, Gerd
Nordhus, Inger Hilde
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2006-06-28
Volume: 295
Issue: 24
Pages: 2851
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.295.24.2851
OpenAlex: W2160984931
Cited by: 589
References: 46
Citations by year: 2026: 9 · 2025: 25 · 2024: 18 · 2023: 17 · 2022: 24 · 2021: 24 · 2020: 29 · 2019: 35 · 2018: 16 · 2017: 39 · 2016: 45 · 2015: 36 · 2014: 39 · 2013: 29 · 2012: 34
FWCI: 42.39
Type: journal article
Language: en
Open access: closed
Locations: JAMA (publishedVersion)
PubMed (publishedVersion)
Topics: Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
Health Sciences › Medicine › Physiology (medical) › Obstructive Sleep Apnea Research
Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Keywords: chronic primary insomnia, older adults, cognitive behavioral therapy, zopiclone, hypnotics, sleep efficiency, slow-wave sleep, sleep restriction, stimulus control, cognitive therapy, relaxation, polysomnography, sleep diary, long-term treatment outcomes
MeSH terms: Aged, Chronic Disease, Double-Blind Method, Female, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Piperazines, Cognitive Behavioral Therapy, Polysomnography, Azabicyclo Compounds

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Cognitive Behavioral Therapy vs Zopiclone for Treatment of Chronic Primary Insomnia in Older Adults: A Randomized Controlled Trial

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