Behavioral and Pharmacological Therapies for Late-Life Insomnia: A Randomized Controlled Trial
Abstract
CONTEXT: Insomnia is a prevalent health complaint in older adults. Behavioral and pharmacological treatments have their benefits and limitations, but no placebo-controlled study has compared their separate and combined effects for late-life insomnia. OBJECTIVE: To evaluate the clinical efficacy of behavioral and pharmacological therapies, singly and combined, for late-life insomnia. DESIGN AND SETTING: Randomized, placebo-controlled clinical trial, at a single 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 chronic and primary insomnia. INTERVENTIONS: Cognitive-behavior therapy (stimulus control, sleep restriction, sleep hygiene, and cognitive therapy) (n = 18), pharmacotherapy (temazepam) (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 subjects, significant others, and clinicians. RESULTS: The 3 active treatments were more effective than placebo at posttreatment assessment; there was a trend for the combined approach to improve sleep more than either of its 2 single components (shorter time awake after sleep onset by sleep diary and polysomnography). For example, the percentage reductions of time awake after sleep onset was highest for the combined condition (63.5%), followed by cognitive-behavior therapy (55%), pharmacotherapy (46.5%), and placebo (16.9%). Subjects treated with behavior therapy sustained their clinical gains at follow-up, whereas those treated with drug therapy alone did not. Long-term outcome of the combined intervention was more variable. Behavioral treatment, singly or combined, was rated by subjects, significant others, and clinicians as more effective than drug therapy alone. Subjects were also more satisfied with the behavioral approach. CONCLUSIONS: Behavioral and pharmacological approaches are effective for the short-term management of insomnia in late life; sleep improvements are better sustained over time with behavioral treatment.
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Short-term pharmacological treatments alone are effective during the course of treatment for chronic insomnia.
“short-term pharmacological treatments alone are effective during the course of treatment for chronic insomnia”
From Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults (2008) · cites this paper as [66]
Taken as a whole, these investigations do not demonstrate a clear advantage for combined treatment over cognitive behavioral treatment alone.
“Taken as a whole, these investigations do not demonstrate a clear advantage for combined treatment over cognitive behavioral treatment alone. 65,66,68-70”
From Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults (2008) · cites this paper as [66]
Short-term pharmacological treatments alone do not provide sustained improvement following discontinuation.
“but do not provide sustained improvement following discontinuation, 65,66”
From Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults (2008) · cites this paper as [66]
Cognitive Behavioral Therapy for Insomnia does not carry the risks of prescription hypnotic medications and is therefore preferable for reasons beyond demonstrated efficacy, efficacy relative to medications, and effectiveness.
“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 [252]
The trials compared CBT-I to zopiclone, zolpidem, temazepam, and triazolam.
“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 [31]
In Morin's study, the Sleep Impairment Index declined 10 points after 24 months for CBT-I patients versus 4 points for temazepam patients (p = 0.01).
“In Morin’s study [31] the Sleep Impairment Index declined 10 points after 24 months for patients treated with CBT-I, but only 4 points for patients given tamezepam (p = 0.01).”
From Comparative effectiveness of cognitive behavioral therapy for insomnia: a systematic review (2012) · cites this paper as [31]
Three included studies had a treatment arm combining CBT-I and medication.
“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 [31]
CBTI has been shown to be efficacious for the treatment of chronic insomnia in older adults.
“CBTI has also been shown to be efficacious for the treatment of chronic insomnia in older adults [33,36].”
From Non-Pharmacological Treatment of Insomnia (2012) · cites this paper as [33]
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- Authors
- Morin, C. M., Colecchi, C., Stone, J., Sood, R., & Brink, D.
- Affiliations
- Université Laval (CA)
- ORCID
- Morin, Charles M.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 1999-03-17
- Volume
- 281
- Issue
- 11
- Pages
- 991
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2079808059
- Cited by
- 1,095
- References
- 31
- Citations by year
- 2026: 19 · 2025: 20 · 2024: 19 · 2023: 26 · 2022: 29 · 2021: 33 · 2020: 36 · 2019: 39 · 2018: 34 · 2017: 40 · 2016: 41 · 2015: 48 · 2014: 51 · 2013: 43 · 2012: 53
- FWCI
- 57.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5r29mh047020-05)
- National Institute of Mental Health (MH47020)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Keywords
- cognitive behavioral therapy for insomnia, temazepam, sleep restriction, stimulus control, sleep hygiene, cognitive therapy, sleep efficiency, older adults, long-term treatment outcomes, patient satisfaction
- MeSH terms
- Aged, Analysis of Variance, Behavior Therapy, Chronic Disease, Combined Modality Therapy, Female, Humans, Sleep Initiation and Maintenance Disorders, Male, Temazepam, Anti-Anxiety Agents, Cognitive Behavioral Therapy, Polysomnography
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