Cognitive Behavior Therapy and Pharmacotherapy for Insomnia: A Randomized Controlled Trial and Direct Comparison
Abstract
Background Chronic sleep-onset insomnia is a prevalent health complaint in adults. Although behavioral and pharmacological therapies have been shown to be effective for insomnia, no placebo-controlled trials have evaluated their separate and combined effects for sleep-onset insomnia. The objective of this study was to evaluate the clinical efficacy of behavioral and pharmacological therapy, singly and in combination, for chronic sleep-onset insomnia. Methods This was a randomized, placebo-controlled clinical trial that involved 63 young and middle-aged adults with chronic sleep-onset insomnia. Interventions included cognitive behavior therapy (CBT), pharmacotherapy, or combination therapy compared with placebo. The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning. Results In most measures, CBT was the most sleep effective intervention; it produced the greatest changes in sleep-onset latency and sleep efficiency, yielded the largest number of normal sleepers after treatment, and maintained therapeutic gains at long-term follow-up. The combined treatment provided no advantage over CBT alone, whereas pharmacotherapy produced only moderate improvements during drug administration and returned measures toward baseline after drug use discontinuation. Conclusi…
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CBTi is a first-line treatment with sufficient empirical support to be recommended for treating chronic insomnia.
“CBTi is a first-line treatment with sufficient empirical support to be recommended for treating chronic insomnia [20].”
From Tamper-Resistant Mobile Health Using Blockchain Technology. (2017) · cites this paper as [20]
CBT-I is a non-pharmacological treatment that modifies dysfunctional behaviors and cognition regarding sleep and is traditionally suggested as the first-line treatment in the United States and Europe.
“Cognitive Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacological treatment that modifies dysfunctional behaviors and cognition regarding sleep, and is traditionally suggested as the first-line of treatment in the United States and Europe.1”
From Comparison of Acceptance and Commitment Therapy (ACT) and Cognitive Behavior Therapy (CBT) for Chronic Insomnia: A Pilot Randomized Controlled Trial (2023) · cites this paper as [1]
Pharmacotherapy produced only moderate improvements that were limited to the duration of drug administration.
“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 [99]
Three RCTs comparing CBT-I, benzodiazepine and placebo for chronic insomnia all show that CBT-I was the most effective sleep intervention.
“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 [99]
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 [65]
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 [65]
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 [65]
A similar association between short sleep duration and shorter leukocyte telomere length was found in older, but not middle-aged, adults (n = 154) and in children (n = 1,567).
“A similar association was found in older, but not middle-aged, adults (n = 154) (125) and was recently also reported in children (n = 1,567)”
From The Sleep-Immune Crosstalk in Health and Disease (2019) · cites this paper as [271]
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 [250]
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 [30]
In another randomized controlled trial, sleep latency percentage change based on sleep diary revealed pre-to post-treatment effect sizes for CBTI (d=1.17), combined CBTI and medication (d=1.08), and medication (d=0.51); at follow-up, increased sleep latency was seen in the medication and combined groups compared with CBTI only.
“Sleep latency percentage change based on sleep diary revealed pre-to post-treatment effect sizes for the CBTI group (Cohen's d01.17), combined CBTI and medication group (d 01.08), and medication group (d00.51).At follow-up, increased sleep latency was seen in the medication group and the combined CBTI and medication group, as compared with the CBTI only group.”
From Non-Pharmacological Treatment of Insomnia (2012) · cites this paper as [34]
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- Authors
- Jacobs, G. D., Pace-Schott, E. F., Stickgold, R., & Otto, M. W.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Venue
- Archives of Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2004-09-27
- Volume
- 164
- Issue
- 17
- Pages
- 1888
- ISSN
- 0003-9926 (ISSN-L)
- OpenAlex
- W2172054698
- Cited by
- 579
- References
- 26
- Citations by year
- 2026: 13 · 2025: 15 · 2024: 14 · 2023: 23 · 2022: 23 · 2021: 30 · 2020: 15 · 2019: 30 · 2018: 22 · 2017: 25 · 2016: 41 · 2015: 35 · 2014: 26 · 2013: 24 · 2012: 39
- FWCI
- 34.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5r29hl059387-04)
- National Heart, Lung, and Blood Institute (HL59387)
- National Institute on Drug Abuse (DA117440)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Keywords
- chronic insomnia, sleep onset insomnia, cognitive behavioral therapy, pharmacotherapy, combination therapy, sleep latency, sleep efficiency, daytime functioning, treatment efficacy, young and middle-aged adults
- MeSH terms
- Zolpidem, Adult, Combined Modality Therapy, Double-Blind Method, Female, Follow-Up Studies, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Prospective Studies, Pyridines, Cognitive Behavioral Therapy, Treatment Outcome, Polysomnography
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