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Effect of Psychological and Medication Therapies for Insomnia on Daytime Functions: A Randomized Clinical Trial

Author/s: 
Charles M Morin, Si-Jing Chen, Hans Ivers, Simon Beaulieu-Bonneau, Andrew D Krystal, Bernard Guay, Lynda Bélanger, Ann Cartwright, Bryan Simmons, Manon Lamy, Mindy Busby, Jack D Edinger

Importance: Daytime functional impairments are the primary reasons for patients with insomnia to seek treatment, yet little is known about what the optimal treatment is for improving daytime functions and how best to proceed with treatment for patients whose insomnia has not remitted.

Objectives: To compare the efficacy of behavioral therapy (BT) and zolpidem as initial therapies for improving daytime functions among patients with insomnia and evaluate the added value of a second treatment for patients whose insomnia has not remitted.

Design, setting, and participants: In this sequential multiple-assignment randomized clinical trial conducted at institutions in Canada and the US, 211 adults with chronic insomnia disorder were enrolled between May 1, 2012, and December 31, 2015, and followed up for 12 months. Statistical analyses were performed on an intention-to-treat basis in April and October 2023.

Interventions: Participants were randomly assigned to either BT or zolpidem as first-stage therapy, and those whose insomnia had not remitted received a second-stage psychological therapy (BT or cognitive therapy) or medication therapy (zolpidem or trazodone).

Main outcomes and measures: Study outcomes were daytime symptoms of insomnia, including mood disturbances, fatigue, functional impairments of insomnia, and scores on the 36-item Short-Form Health Survey (SF-36) physical and mental health components.

Results: Among 211 adults with insomnia (132 women [63%]; mean [SD] age, 45.6 [14.9] years), 104 were allocated to BT and 107 to zolpidem at the first stage. First-stage treatment with BT or zolpidem yielded significant and equivalent benefits for most of the daytime outcomes, including depressive symptoms (Beck Depression Inventory-II mean score change, -3.5 [95% CI, -4.7 to -2.3] vs -4.3 [95% CI, -5.7 to -2.9]), fatigue (Multidimensional Fatigue Inventory mean score change, -4.7 [95% CI, -7.3 to -2.2] vs -5.2 [95% CI, -7.9 to -2.5]), functional impairments (Work and Social Adjustment Scale mean score change, -5.0 [95% CI, -6.7 to -3.3] vs -5.1 [95% CI, -7.2 to -2.9]), and mental health (SF-36 mental health subscale mean score change, 3.5 [95% CI, 1.9-5.1] vs 2.5 [95% CI, 0.4-4.5]), while BT produced larger improvements for anxiety symptoms relative to zolpidem (State-Trait Anxiety Inventory mean score change, -4.1 [95% CI, -5.8 to -2.4] vs -1.2 [95% CI, -3.0 to 0.5]; P = .02; Cohen d = 0.55). Second-stage therapy produced additional improvements for the 2 conditions starting with zolpidem at posttreatment in fatigue (Multidimensional Fatigue Inventory mean score change: zolpidem plus BT, -3.8 [95% CI, -7.1 to -0.4]; zolpidem plus trazodone, -3.7 [95% CI, -6.3 to -1.1]), functional impairments (Work and Social Adjustment Scale mean score change: zolpidem plus BT, -3.7 [95% CI, -6.4 to -1.0]; zolpidem plus trazodone, -3.3 [95% CI, -5.9 to -0.7]) and mental health (SF-36 mental health subscale mean score change: zolpidem plus BT, 5.3 [95% CI, 2.7-7.9]; zolpidem plus trazodone, 2.0 [95% CI, 0.1-4.0]). Treatment benefits achieved at posttreatment were well maintained throughout the 12-month follow-up, and additional improvements were noted for patients receiving the BT treatment sequences.

Conclusions and relevance: In this randomized clinical trial of adults with insomnia disorder, BT and zolpidem produced improvements for various daytime symptoms of insomnia that were no different between treatments. Adding a second treatment offered an added value with further improvements of daytime functions.

Trial registration: ClinicalTrials.gov Identifier: NCT01651442.

Keywords 
Insomnia Insomnia medications sleep behavior therapy cognitive behavior therapy

Seasonal Affective Disorder

What is seasonal affective disorder?

Many people go through short periods when they feel sad or unlike their usual selves. Sometimes, these mood changes begin and end when the seasons change. Many people feel "down" or have the "winter blues" when the days get shorter in the fall and winter and feel better in the spring when longer daylight hours return.

Sometimes, these mood changes are more serious and can affect how a person feels, thinks, and behaves. If you have noticed significant changes in your mood and behavior when the seasons change, you may be experiencing seasonal affective disorder (SAD).

In most cases, SAD symptoms start in the late fall or early winter and go away during the spring and summer, known as winter-pattern SAD or winter depression. Other people experience depressive symptoms during the spring and summer months, known as summer-pattern SAD or summer depression. Summer-pattern SAD is less common.

Keywords 
Seasonal Affective Disorder depression sleep Appetite Season winter

Mortality and concurrent use of opioids and hypnotics in older patients: A retrospective cohort study

Author/s: 
W. A., Chung, C. P., Murray, K. T., Malow, B. A., Daugherty, J. R., Stein, C. M.

Background: Benzodiazepine hypnotics and the related nonbenzodiazepine hypnotics (z-drugs) are among the most frequently prescribed medications for older adults. Both can depress respiration, which could have fatal cardiorespiratory effects, particularly among patients with concurrent opioid use. Trazodone, frequently prescribed in low doses for insomnia, has minimal respiratory effects, and, consequently, may be a safer hypnotic for older patients. Thus, for patients beginning treatment with benzodiazepine hypnotics or z-drugs, we compared deaths during periods of current hypnotic use, without or with concurrent opioids, to those for comparable patients receiving trazodone in doses up to 100 mg.

Methods and findings: The retrospective cohort study in the United States included 400,924 Medicare beneficiaries 65 years of age or older without severe illness or evidence of substance use disorder initiating study hypnotic therapy from January 2014 through September 2015. Study endpoints were out-of-hospital (primary) and total mortality. Hazard ratios (HRs) were adjusted for demographic characteristics, psychiatric and neurologic disorders, cardiovascular and renal conditions, respiratory diseases, pain-related diagnoses and medications, measures of frailty, and medical care utilization in a time-dependent propensity score-stratified analysis. Patients without concurrent opioids had 32,388 person-years of current use, 260 (8.0/1,000 person-years) out-of-hospital and 418 (12.9/1,000) total deaths for benzodiazepines; 26,497 person-years,150 (5.7/1,000) out-of-hospital and 227 (8.6/1,000) total deaths for z-drugs; and 16,177 person-years,156 (9.6/1,000) out-of-hospital and 256 (15.8/1,000) total deaths for trazodone. Out-of-hospital and total mortality for benzodiazepines (respective HRs: 0.99 [95% confidence interval, 0.81 to 1.22, p = 0.954] and 0.95 [0.82 to 1.14, p = 0.513] and z-drugs (HRs: 0.96 [0.76 to 1.23], p = 0.767 and 0.87 [0.72 to 1.05], p = 0.153) did not differ significantly from that for trazodone. Patients with concurrent opioids had 4,278 person-years of current use, 90 (21.0/1,000) out-of-hospital and 127 (29.7/1,000) total deaths for benzodiazepines; 3,541 person-years, 40 (11.3/1,000) out-of-hospital and 64 (18.1/1,000) total deaths for z-drugs; and 2,347 person-years, 19 (8.1/1,000) out-of-hospital and 36 (15.3/1,000) total deaths for trazodone. Out-of-hospital and total mortality for benzodiazepines (HRs: 3.02 [1.83 to 4.97], p < 0.001 and 2.21 [1.52 to 3.20], p < 0.001) and z-drugs (HRs: 1.98 [1.14 to 3.44], p = 0.015 and 1.65 [1.09 to 2.49], p = 0.018) were significantly increased relative to trazodone; findings were similar with exclusion of overdose deaths or restriction to those with cardiovascular causes. Limitations included composition of the study cohort and potential confounding by unmeasured variables.

Conclusions: In US Medicare beneficiaries 65 years of age or older without concurrent opioids who initiated treatment with benzodiazepine hypnotics, z-drugs, or low-dose trazodone, study hypnotics were not associated with mortality. With concurrent opioids, benzodiazepines and z-drugs were associated with increased out-of-hospital and total mortality. These findings indicate that the dangers of benzodiazepine-opioid coadministration go beyond the documented association with overdose death and suggest that in combination with opioids, the z-drugs may be more hazardous than previously thought.

Keywords 
opioids Hypnotics cohort study mortality Drug Overdose

Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial

Author/s: 
McCurry, Susan M., Zhu, Weiwei, Von Korff, Michael, Wellman, Robert, Morin, Charles M., Thakral, Manu, Yeung, Kai, Vitiello, Michael V.

Importance: Scalable delivery models of cognitive behavioral therapy for insomnia (CBT-I), an effective treatment, are needed for widespread implementation, particularly in rural and underserved populations lacking ready access to insomnia treatment.

Objective: To evaluate the effectiveness of telephone CBT-I vs education-only control (EOC) in older adults with moderate to severe osteoarthritis pain.

Design, setting, and participants: This is a randomized clinical trial of 327 participants 60 years and older who were recruited statewide through Kaiser Permanente Washington from September 2016 to December 2018. Participants were double screened 3 weeks apart for moderate to severe insomnia and osteoarthritis (OA) pain symptoms. Blinded assessments were conducted at baseline, after 2 months posttreatment, and at 12-month follow-up.

Interventions: Six 20- to 30-minute telephone sessions provided over 8 weeks. Participants submitted daily diaries and received group-specific educational materials. The CBT-I instruction included sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and homework. The EOC group received information about sleep and OA.

Main outcomes and measures: The primary outcome was score on the Insomnia Severity Index (ISI) at 2 months posttreatment and 12-month follow-up. Secondary outcomes included pain (score on the Brief Pain Inventory-short form), depression (score on the 8-item Patient Health Questionnaire), and fatigue (score on the Flinders Fatigue Scale).

Results: Of the 327 participants, the mean (SD) age was 70.2 (6.8) years, and 244 (74.6%) were women. In the 282 participants with follow-up ISI data, the total 2-month posttreatment ISI scores decreased 8.1 points in the CBT-I group and 4.8 points in the EOC group, an adjusted mean between-group difference of -3.5 points (95% CI, -4.4 to -2.6 points; P < .001). Results were sustained at 12-month follow-up (adjusted mean difference, -3.0 points; 95% CI, -4.1 to -2.0 points; P < .001). At 12-month follow-up, 67 of 119 (56.3%) participants receiving CBT-I remained in remission (ISI score, ≤7) compared with 33 of 128 (25.8%) participants receiving EOC. Fatigue was also significantly reduced in the CBT-I group compared with the EOC group at 2 months posttreatment (mean between-group difference, -2.0 points; 95% CI, -3.1 to -0.9 points; P = <.001) and 12-month follow-up (mean between-group difference, -1.8 points; 95% CI, -3.1 to -0.6 points; P = .003). Posttreatment significant differences were observed for pain, but these differences were not sustained at 12-month follow-up.

Conclusions and relevance: In this randomized clinical trial, telephone CBT-I was effective in improving sleep, fatigue, and, to a lesser degree, pain among older adults with comorbid insomnia and OA pain in a large statewide health plan. Results support provision of telephone CBT-I as an accessible, individualized, effective, and scalable insomnia treatment.

Keywords 
Telephone Cognitive Behavioral Therapy osteoarthritis Pain aged Elderly care older adults

Overcoming Barriers to the Diagnosis and Treatment of Insomnia

Author/s: 
Roth, Thomas

Apply evidence-based diagnostic guidelines for patients who have clinical features consistent with insomnia. Use evidence-based guidelines to develop comprehensive treatment plans that include cognitive-behavioral therapy, pharmacologic treatment, and combination therapies to achieve optimal outcomes Identify basic elements of cognitivebehavioral therapy for insomnia Differentiate among medications FDA-approved for treating insomnia by discussing mechanism of action, safety, efficacy, and use.

Keywords 
Insomnia cognitive behavioral therapy Insomnia medications

The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines

Author/s: 
Mysliwiec, V., Martin, J.L., Ulmer, J.S., Chowdhuri, S., Brock, M.S., Spevak, C.

Abstract

Description:

In September 2019, the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) approved a new joint clinical practice guideline for assessing and managing patients with chronic insomnia disorder and obstructive sleep apnea (OSA). This guideline is intended to give health care teams a framework by which to screen, evaluate, treat, and manage the individual needs and preferences of VA and DoD patients with either of these conditions.

Methods:

In October 2017, the VA/DoD Evidence-Based Practice Work Group initiated a joint VA/DoD guideline development effort that included clinical stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions, systematically searched and evaluated the literature, created three 1-page algorithms, and advanced 41 recommendations using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.

Recommendations:

This synopsis summarizes the key recommendations of the guideline in 3 areas: diagnosis and assessment of OSA and chronic insomnia disorder, treatment and management of OSA, and treatment and management of chronic insomnia disorder. Three clinical practice algorithms are also included.

The National Institutes of Health has estimated that insomnia and obstructive sleep apnea (OSA) are 2 of the most common sleep disorders in the general U.S. population and in the military and veteran populations (1). Insomnia symptoms are the most common sleep symptoms among U.S. adults, occurring in approximately 20% to 30% of adults, and the prevalence of chronic insomnia disorder ranges from 6% to 10% (2–6). The prevalence of OSA ranges from 9% to 38% and is associated with older age, higher body mass index, male sex, and menopause.

Sleep disorders are more prevalent in the populations served by the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) than in the general civilian population. In the RAND report “Sleep in the Military: Promoting Healthy Sleep Among U.S. Servicemembers,” 48.6% of military personnel surveyed had poor sleep quality (Pittsburgh Sleep Quality Index score >5) (7). The prevalence of insomnia symptoms has been reported to be as high as 41% in service members deployed to combat and 25% in noncombatants (8). In a large cohort of soldiers preparing for deployment, 19.9% met criteria for insomnia according to the Insomnia Severity Index (ISI) (8). A more recent study evaluated the incidence of insomnia and OSA in the entire population of U.S. Army soldiers from 1997 to 2011 (9) and showed unprecedented increases in the incidence of both conditions (652% and 600%, respectively) during this period. In military personnel referred for sleep evaluations, sleep-disordered breathing is the most frequently diagnosed disorder, and some studies have found that military personnel have high rates of comorbid insomnia and OSA (10, 11). Further, military personnel with sleep disorders often also have posttraumatic stress disorder (PTSD), symptoms of anxiety and depression, and traumatic brain injury, which can complicate diagnosis and management (11–13).

Sleep disturbances are also common in veterans (14–16). Similar to findings from active-duty service members, the National Veteran Sleep Disorder Study found that the number of veterans diagnosed with sleep disorders increased nearly 6-fold from 2000 to 2010. In this study, 4.5% of veterans were diagnosed with sleep-disordered breathing, and 2.5% were diagnosed with insomnia. However, the actual prevalence of insomnia disorder among veterans is likely to be considerably higher (17) because it is often not documented in the medical record (18, 19). Comorbid PTSD was associated with a 7.6-fold greater risk for OSA and a 6.3-fold greater risk for insomnia (15). Because veterans have high rates of cardiovascular disease and PTSD, and because OSA is more prevalent in patients with these disorders (20), there is likely a large percentage of veterans who have not yet been diagnosed with OSA (21).

Keywords 
evaluation sleep apnea chronic insomnia
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