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Cognitive Behavioral Therapy vs Zopiclone for Treatment of Chronic Primary Insomnia in Older Adults: A Randomized Controlled Trial
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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“Three RCTs [99,100,101] which compared CBT-I, BZD and placebo for chronic insomnia all show that CBT-I was the most effective sleep intervention.”
From Cognitive behavioral therapy and acceptance and commitment therapy for the discontinuation of long-term benzodiazepine use in insomnia and anxiety disorders (2021) · cites this paper as [100]
In the citing paper
“Notably, pharmacotherapy produced only moderate improvements that were limited to the duration of drug administration.”
From Cognitive behavioral therapy and acceptance and commitment therapy for the discontinuation of long-term benzodiazepine use in insomnia and anxiety disorders (2021) · cites this paper as [100]
In the citing paper
“one study found that the interplay between inflammatory and stress markers at the cell level, as assessed in vitro by the sensitivity of monocytes to the counter-inflammatory cortisol signal, was dysregulated following prolonged sleep restriction in humans”
From The Sleep-Immune Crosstalk in Health and Disease (2019) · cites this paper as [512]
In the citing paper
“The recommended first-line treatment, Cognitive Behavioral Therapy for Insomnia (CBTI) does not carry these risks and is therefore preferable for reasons beyond demonstrated efficacy(244-248), efficacy relative to medications(249-253), and effectiveness(254).”
From Sleep: important considerations for the prevention of cardiovascular disease (2016) · cites this paper as [253]
In the citing paper
“The trials compared CBT-I to zopiclone [29], zolpidem [30], temazepam [31,32], and triazolam [33].”
From Comparative effectiveness of cognitive behavioral therapy for insomnia: a systematic review (2012) · cites this paper as [29]
In the citing paper
“Of note, three of the studies [29,31,32] included a treatment arm that was a combination of CBT-I and medication.”
From Comparative effectiveness of cognitive behavioral therapy for insomnia: a systematic review (2012) · cites this paper as [29]
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“CBT increases the absolute amount of slow-wave sleep by about 30% (Sivertsen et al, 2006).”
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Metadata
- 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
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2006-06-28
- Volume
- 295
- Issue
- 24
- Pages
- 2851
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- 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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