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JAMA Feb 2013Insomnia is one of the most prevalent health concerns in the population and in clinical practice. Clinicians may be reluctant to address insomnia because of its many... (Review)
Review
IMPORTANCE
Insomnia is one of the most prevalent health concerns in the population and in clinical practice. Clinicians may be reluctant to address insomnia because of its many potential causes, unfamiliarity with behavioral treatments, and concerns about pharmacologic treatments.
OBJECTIVE
To review the assessment, diagnosis, and treatment of insomnia in adults.
EVIDENCE REVIEW
Systematic review to identify and summarize previously published quantitative reviews (meta-analyses) of behavioral and pharmacologic treatments for insomnia.
FINDINGS
Insomnia is a common clinical condition characterized by difficulty initiating or maintaining sleep, accompanied by symptoms such as irritability or fatigue during wakefulness. The prevalence of insomnia disorder is approximately 10% to 20%, with approximately 50% having a chronic course. Insomnia is a risk factor for impaired function, development of other medical and mental disorders, and increased health care costs. The etiology and pathophysiology of insomnia involve genetic, environmental, behavioral, and physiological factors culminating in hyperarousal. The diagnosis of insomnia is established by a thorough history of sleep behaviors, medical and psychiatric problems, and medications, supplemented by a prospective record of sleep patterns (sleep diary). Quantitative literature reviews (meta-analyses) support the efficacy of behavioral, cognitive, and pharmacologic interventions for insomnia. Brief behavioral interventions and Internet-based cognitive-behavioral therapy both show promise for use in primary care settings. Among pharmacologic interventions, the most evidence exists for benzodiazepine receptor agonist drugs, although persistent concerns focus on their safety relative to modest efficacy. Behavioral treatments should be used whenever possible, and medications should be limited to the lowest necessary dose and shortest necessary duration.
CONCLUSIONS AND RELEVANCE
Clinicians should recognize insomnia because of its effects on function and health. A thorough clinical history is often sufficient to identify factors that contribute to insomnia. Behavioral treatments should be used when possible. Hypnotic medications are also efficacious but must be carefully monitored for adverse effects.
Topics: Cognitive Behavioral Therapy; Female; Humans; Middle Aged; Risk Factors; Sleep Initiation and Maintenance Disorders
PubMed: 23423416
DOI: 10.1001/jama.2013.193 -
American Family Physician Dec 2015Insomnia affects 10% to 30% of the population with a total cost of $92.5 to $107.5 billion annually. Short-term, chronic, and other types of insomnia are the three major... (Review)
Review
Insomnia affects 10% to 30% of the population with a total cost of $92.5 to $107.5 billion annually. Short-term, chronic, and other types of insomnia are the three major categories according to the International Classification of Sleep Disorders, 3rd ed. The criteria for diagnosis are difficulty falling asleep, difficulty staying asleep, or early awakening despite the opportunity for sleep; symptoms must be associated with impaired daytime functioning and occur at least three times per week for at least one month. Factors associated with the onset of insomnia include a personal or family history of insomnia, easy arousability, poor self-reported health, and chronic pain. Insomnia is more common in women, especially following menopause and during late pregnancy, and in older adults. A comprehensive sleep history can confirm the diagnosis. Psychiatric and medical problems, medication use, and substance abuse should be ruled out as contributing factors. Treatment of comorbid conditions alone may not resolve insomnia. Patients with movement disorders (e.g., restless legs syndrome, periodic limb movement disorder), circadian rhythm disorders, or breathing disorders (e.g., obstructive sleep apnea) must be identified and treated appropriately. Chronic insomnia is associated with cognitive difficulties, anxiety and depression, poor work performance, decreased quality of life, and increased risk of cardiovascular disease and all-cause mortality. Insomnia can be treated with nonpharmacologic and pharmacologic therapies. Nonpharmacologic therapies include sleep hygiene, cognitive behavior therapy, relaxation therapy, multicomponent therapy, and paradoxical intention. Referral to a sleep specialist may be considered for refractory cases.
Topics: Adult; Aged; Aged, 80 and over; Chronic Disease; Cognitive Behavioral Therapy; Education, Medical, Continuing; Female; Humans; Middle Aged; Practice Guidelines as Topic; Pregnancy; Relaxation Therapy; Sleep Initiation and Maintenance Disorders; United States
PubMed: 26760592
DOI: No ID Found -
Journal of the National Cancer Institute Dec 2019Insomnia is a common and debilitating disorder experienced by cancer survivors. Although cancer survivors express a preference for using nonpharmacological treatment to... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Insomnia is a common and debilitating disorder experienced by cancer survivors. Although cancer survivors express a preference for using nonpharmacological treatment to manage insomnia, the comparative effectiveness between acupuncture and Cognitive Behavioral Therapy for Insomnia (CBT-I) for this disorder is unknown.
METHODS
This randomized trial compared 8 weeks of acupuncture (n = 80) and CBT-I (n = 80) in cancer survivors. Acupuncture involved stimulating specific points on the body with needles. CBT-I included sleep restriction, stimulus control, cognitive restructuring, relaxation training, and education. We measured insomnia severity (primary outcome), pain, fatigue, mood, and quality of life posttreatment (8 weeks) with follow-up until 20 weeks. We used linear mixed-effects models for analyses. All statistical tests were two-sided.
RESULTS
The mean age was 61.5 years and 56.9% were women. CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: -8.31 points, 95% confidence interval = -9.36 to -7.26; CBT-I: -10.91 points, 95% confidence interval = -11.97 to -9.85) and maintained improvements up to 20 weeks. Acupuncture was more effective for pain at the end of treatment; both groups had similar improvements in fatigue, mood, and quality of life and reduced prescription hypnotic medication use. CBT-I was more effective for those who were male (P < .001), white (P = .003), highly educated (P < .001), and had no pain at baseline (P < .001).
CONCLUSIONS
Although both treatments produced meaningful and durable improvements, CBT-I was more effective and should be the first line of therapy. The relative differences in the comparative effectiveness between the two interventions for specific groups should be confirmed in future adequately powered trials to guide more tailored interventions for insomnia.
Topics: Acupuncture Therapy; Affect; Cancer Survivors; Cognitive Behavioral Therapy; Confidence Intervals; Fatigue; Female; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Sleep Initiation and Maintenance Disorders; Socioeconomic Factors; Treatment Outcome
PubMed: 31081899
DOI: 10.1093/jnci/djz050 -
JAMA Psychiatry Jan 2022Older adults with insomnia have a high risk of incident and recurrent depression. Depression prevention is urgently needed, and such efforts have been neglected for... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Older adults with insomnia have a high risk of incident and recurrent depression. Depression prevention is urgently needed, and such efforts have been neglected for older adults.
OBJECTIVE
To examine whether treatment of insomnia disorder with cognitive behavioral therapy for insomnia (CBT-I) compared with an active comparator condition, sleep education therapy (SET), prevents major depressive disorder in older adults.
DESIGN, SETTING, AND PARTICIPANTS
This assessor-blinded, parallel-group, single-site randomized clinical trial assessed a community-based sample of 431 people and enrolled 291 adults 60 years or older with insomnia disorder who had no major depression or major health events in past year. Study recruitment was performed from July 1, 2012, to April 30, 2015. The trial protocol was modified to extend follow-up from 24 to 36 months, with follow-up completion in July 2018. Data analysis was performed from March 1, 2019, to March 30, 2020.
INTERVENTIONS
Participants were randomized to 2 months of CBT-I (n = 156) or SET (n = 135).
MAIN OUTCOMES AND MEASURES
The primary outcome was time to incident major depressive disorder as diagnosed by interview and Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria. Secondary outcome was sustained remission of insomnia disorder before depression event or duration of follow-up.
RESULTS
Among 291 randomized participants (mean [SD] age, 70.1 [6.7] years; 168 [57.7%] female; 7 [2.4%] Asian, 32 [11.0%] Black, 3 [1.0%] Pacific Islander, 241 [82.8%] White, 6 [2.1%] multiracial, and 2 [0.7%] unknown), 156 were randomized to CBT-I and 135 to SET. A total of 140 participants (89.7%) completed CBT-I and 130 (96.3%) participants completed SET (χ2 = 4.9, P = .03), with 114 (73.1%) completing 24 months of follow-up in the CBT-I group and 117 (86.7%) in the SET group (χ2 = 8.4, P = .004). After protocol modification, 92 (59.0%) of the CBT-I participants and 86 (63.7%) of the SET participants agreed to extended follow-up (χ2 = 0.7, P = .41), with 81 (51.9%) of the CBT-I participants and 77 (57.0%) of the SET group completing 36 months of follow-up (χ2 = 0.8; P = .39). Incident or recurrent major depression occurred in 19 participants (12.2%) in the CBT-I group and in 35 participants (25.9%) in the SET group, with an overall benefit (hazard ratio, 0.51; 95%, CI 0.29-0.88; P = .02) consistent across subgroups. Remission of insomnia disorder continuously sustained before depression event or during follow-up was more likely in CBT-I participants (41 [26.3%]) compared with the SET participants (26 [19.3%], P = .03). Those in the CBT-I group with sustained remission of insomnia disorder had an 82.6% decreased likelihood of depression (hazard ratio, 0.17; 95%, CI 0.04-0.73; P = .02) compared with those in the SET group without sustained remission of insomnia disorder.
CONCLUSIONS AND RELEVANCE
The findings of this randomized clinical trial indicate that treatment of insomnia with CBT-I has an overall benefit in the prevention of incident and recurrent major depression in older adults with insomnia disorder. Community-level screening for insomnia concerns in older adults and wide delivery of CBT-I-based treatment for insomnia could substantially advance public health efforts to treat insomnia and prevent depression in this vulnerable older adult population.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01641263.
Topics: Aged; Aged, 80 and over; Cognitive Behavioral Therapy; Depressive Disorder, Major; Female; Humans; Male; Middle Aged; Sleep Initiation and Maintenance Disorders; Surveys and Questionnaires; Treatment Outcome
PubMed: 34817561
DOI: 10.1001/jamapsychiatry.2021.3422 -
Sleep Nov 2021This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract... (Randomized Controlled Trial)
Randomized Controlled Trial
STUDY OBJECTIVES
This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months).
METHODS
Co-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.
RESULTS
Twenty-three of 24 randomized participants (n = 20 female, mean age 53 ± 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (-5.07 units [95% CI: -7.28 to -2.86]; p = 0.0001) and self-reported SOL (-8.45 min [95% CI: -16.33 to -0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (-10.2 min [95% CI: -16.2 to -4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).
CONCLUSIONS
Two weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms.
CLINICAL TRIAL
ANZCTR; anzctr.org.au; ACTRN12618000078257.
Topics: Adult; Cannabinoids; Cross-Over Studies; Double-Blind Method; Female; Humans; Medical Marijuana; Middle Aged; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 34115851
DOI: 10.1093/sleep/zsab149 -
Sleep Jan 2022Insomnia is common among adults with chronic heart failure (HF) and associated with daytime symptoms and decrements in function. The purpose of this randomized... (Randomized Controlled Trial)
Randomized Controlled Trial
Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study.
STUDY OBJECTIVES
Insomnia is common among adults with chronic heart failure (HF) and associated with daytime symptoms and decrements in function. The purpose of this randomized controlled trial (RCT) was to evaluate the sustained effects over one year of CBT-I (Healthy Sleep: HS) compared with HF self-management education (Healthy Hearts; attention control: HH) on insomnia severity, sleep characteristics, symptoms, and function among people with stable HF. The primary outcomes were insomnia severity, actigraph-recorded sleep efficiency, and fatigue.
METHODS
We randomized adults with stable HF with preserved or reduced ejection fraction who had at least mild insomnia (Insomnia severity index >7) in groups to HS or HH (4 sessions/8 weeks). We obtained wrist actigraphy and measured insomnia severity, self-reported sleep characteristics, symptoms (fatigue, excessive daytime sleepiness, anxiety, depression), and six-minute walk distance at baseline, within one month of treatment, and at 6 and 12 months. We used general linear mixed models (GLMM) and generalized estimating equations (GEE) to evaluate the effects.
RESULTS
The sample included 175 participants (M age = 63 ± 12.9 years; 43% women; 18% Black; 68% New York Heart Association Class II or II; 33%; LVEF < 45%) randomized to HS (n = 91) or HH (n = 84). HS had sustained effects on insomnia severity, sleep quality, self-reported sleep latency and efficiency, fatigue, excessive daytime sleepiness, and six-minute walk distance at 12 months.
CONCLUSIONS
CBT-I produced sustained improvements in insomnia, fatigue, daytime sleepiness, and objectively measured physical function among adults with chronic HF, compared with a robust HF self-management program that included sleep hygiene education.
CLINICAL TRIAL INFORMATION
Insomnia Self-Management in Heart Failure; https://clinicaltrials.gov/ct2/show/NCT02660385; NCT02660385.
Topics: Adult; Aged; Cognitive Behavioral Therapy; Fatigue; Female; Heart Failure; Humans; Male; Middle Aged; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 34657160
DOI: 10.1093/sleep/zsab252 -
Sleep Medicine Oct 2010To assess the efficacy of moderate aerobic physical activity with sleep hygiene education to improve sleep, mood and quality of life in older adults with chronic... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To assess the efficacy of moderate aerobic physical activity with sleep hygiene education to improve sleep, mood and quality of life in older adults with chronic insomnia.
METHODS
Seventeen sedentary adults aged >or=55 years with insomnia (mean age 61.6 [SD±4.3] years; 16 female) participated in a randomized controlled trial comparing 16 weeks of aerobic physical activity plus sleep hygiene to non-physical activity plus sleep hygiene. Eligibility included primary insomnia for at least 3 months, habitual sleep duration <6.5h and a Pittsburgh Sleep Quality Index (PSQI) score >5. Outcomes included sleep quality, mood and quality of life questionnaires (PSQI, Epworth Sleepiness Scale [ESS], Short-form 36 [SF-36], Center for Epidemiological Studies Depression Scale [CES-D]).
RESULTS
The physical activity group improved in sleep quality on the global PSQI (p<.0001), sleep latency (p=.049), sleep duration (p=.04), daytime dysfunction (p=.027), and sleep efficiency (p=.036) PSQI sub-scores compared to the control group. The physical activity group also had reductions in depressive symptoms (p=.044), daytime sleepiness (p=.02) and improvements in vitality (p=.017) compared to baseline scores.
CONCLUSION
Aerobic physical activity with sleep hygiene education is an effective treatment approach to improve sleep quality, mood and quality of life in older adults with chronic insomnia.
Topics: Affect; Depression; Exercise; Exercise Therapy; Female; Humans; Male; Middle Aged; Patient Compliance; Polysomnography; Psychiatric Status Rating Scales; Quality of Life; Sedentary Behavior; Sleep; Sleep Initiation and Maintenance Disorders
PubMed: 20813580
DOI: 10.1016/j.sleep.2010.04.014 -
Sleep Sep 2014To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. (Randomized Controlled Trial)
Randomized Controlled Trial
STUDY OBJECTIVES
To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia.
DESIGN
Three-arm, single-site, randomized controlled trial.
SETTING
Academic medical center.
PARTICIPANTS
Fifty-four adults with chronic insomnia.
INTERVENTIONS
Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition.
MEASUREMENTS AND RESULTS
Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up.
CONCLUSIONS
Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia.
TRIAL REGISTRATION
Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781.
Topics: Actigraphy; Adult; Arousal; Chronic Disease; Female; Humans; Male; Meditation; Middle Aged; Mindfulness; Self Report; Sleep; Sleep Initiation and Maintenance Disorders; Stress, Psychological; Treatment Outcome
PubMed: 25142566
DOI: 10.5665/sleep.4010 -
Sleep Medicine Mar 2019Depression increases during menopause, and subclinical depressive symptoms increase risk for major depression. Insomnia is common among postmenopausal women and... (Comparative Study)
Comparative Study Randomized Controlled Trial
Treating insomnia improves depression, maladaptive thinking, and hyperarousal in postmenopausal women: comparing cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy, and sleep hygiene education.
INTRODUCTION
Depression increases during menopause, and subclinical depressive symptoms increase risk for major depression. Insomnia is common among postmenopausal women and increases depression-risk in this already-vulnerable population. Recent evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBTI) to treat menopausal insomnia, but it remains unclear whether treating insomnia also alleviates co-occurring depressive symptoms and depressogenic features. This trial tested whether CBTI improves depressive symptoms, maladaptive thinking, and somatic hyperarousal in postmenopausal women with insomnia; as well as whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious.
MATERIALS AND METHODS
Single-site, randomized controlled trial. 117 postmenopausal women (56.34 ± 5.41 years) with peri-or-postmenopausal onset of chronic insomnia were randomized to three treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at baseline, posttreatment, and six-month follow-up.
RESULTS
CBTI produced moderate-to-large reductions in depressive symptoms, whereas SRT produced moderate reductions but not until six months posttreatment. Treatment effects on maladaptive thinking were mixed. CBTI and SRT both produced large improvements in dysfunctional beliefs about sleep, but weaker influences on presleep cognitive arousal, rumination, and worry. Presleep somatic arousal greatly improved in the CBTI group and moderately improved in the SRT group. Improvements in depression, maladaptive thinking, and hyperarousal were linked to improved sleep. SHE produced no durable treatment effects.
CONCLUSIONS
CBTI and SRT reduce depressive symptoms, dysfunctional beliefs about sleep, and presleep somatic hyperarousal in postmenopausal women, with CBTI producing superior results. Despite its cognitive emphasis, cognitive arousal did not respond strongly or durably to CBTI. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov.
REGISTRATION
NCT01933295.
Topics: Cognitive Behavioral Therapy; Depression; Female; Follow-Up Studies; Humans; Middle Aged; Patient Education as Topic; Pessimism; Postmenopause; Sleep Arousal Disorders; Sleep Deprivation; Sleep Hygiene; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 30785053
DOI: 10.1016/j.sleep.2018.11.019 -
Journal of Consulting and Clinical... Jun 2015To determine if a treatment for interepisode bipolar disorder I patients with insomnia improves mood state, sleep, and functioning. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To determine if a treatment for interepisode bipolar disorder I patients with insomnia improves mood state, sleep, and functioning.
METHOD
Alongside psychiatric care, interepisode bipolar disorder I participants with insomnia were randomly allocated to a bipolar disorder-specific modification of cognitive behavior therapy for insomnia (CBTI-BP; n = 30) or psychoeducation (PE; n = 28) as a comparison condition. Outcomes were assessed at baseline, the end of 8 sessions of treatment, and 6 months later. This pilot was conducted to determine initial feasibility and generate effect size estimates.
RESULTS
During the 6-month follow-up, the CBTI-BP group had fewer days in a bipolar episode relative to the PE group (3.3 days vs. 25.5 days). The CBTI-BP group also experienced a significantly lower hypomania/mania relapse rate (4.6% vs. 31.6%) and a marginally lower overall mood episode relapse rate (13.6% vs. 42.1%) compared with the PE group. Relative to PE, CBTI-BP reduced insomnia severity and led to higher rates of insomnia remission at posttreatment and marginally higher rates at 6 months. Both CBTI-BP and PE showed statistically significant improvement on selected sleep and functional impairment measures. The effects of treatment were well sustained through follow-up for most outcomes, although some decline on secondary sleep benefits was observed.
CONCLUSIONS
CBTI-BP was associated with reduced risk of mood episode relapse and improved sleep and functioning on certain outcomes in bipolar disorder. Hence, sleep disturbance appears to be an important pathway contributing to bipolar disorder. The need to develop bipolar disorder-specific sleep diary scoring standards is highlighted.
Topics: Adult; Affect; Bipolar Disorder; Cognitive Behavioral Therapy; Female; Humans; Male; Middle Aged; Pilot Projects; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 25622197
DOI: 10.1037/a0038655