A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife women

Study Objectives The neuropeptide orexin promotes wakefulness, modulates thermoregulation, increases after menopause, and is normalized in women receiving estrogen therapy, suggesting a role for orexin antagonism as a treatment for vasomotor symptom (VMS)-associated insomnia disorder. We tested the efficacy of the dual orexin receptor antagonist suvorexant for chronic insomnia related to nighttime VMS. Methods In a double-blind, placebo-controlled trial, 56 women with chronic insomnia associated with nighttime VMS, Insomnia Severity Index (ISI) scores ≥15, and >30 minutes of diary-rated wake after sleep-onset (WASO) were randomized to receive oral suvorexant 10-20 mg (n=27) or placebo (n=29) nightly for 4 weeks. Analysis of within-person change in ISI was adjusted for baseline ISI and race. Results Mean baseline ISI scores were 18.1 (95% CI, 16.8-19.4) and 18.3 (95% CI, 17.2-19.5) in the suvorexant and placebo groups, respectively (p=0.81). The average 4-week ISI within-person decrease from baseline was greater on suvorexant [-8.1 (95% CI, -10.2 to -6.0)] compared to placebo [-5.6 (95% CI, -7.4 to -3.9), p=0.04]. Compared to placebo, nighttime diary-rated VMS frequency was significantly reduced with suvorexant (p<0.01). While diary-rated WASO and total sleep time trended toward improvement on suvorexant, findings were not significant after adjustment for multiple comparison. Daytime VMS and other sleep-related outcomes did not differ between groups. Suvorexant was well tolerated. Conclusion These results suggest that suvorexant is likely a well-tolerated and efficacious treatment for VMS-associated insomnia disorder and reduces nighttime VMS. Antagonism of orexin receptors could provide a novel therapeutic option for midlife women with VMS-associated chronic insomnia.

Differentiating perinatal Insomnia Disorder and sleep disruption: A longitudinal study from pregnancy to 2 years postpartum

Study Objectives Insomnia Disorder diagnoses require persistent sleep complaints despite “adequate sleep opportunity”. Significant perinatal sleep disruption makes this diagnosis challenging. This longitudinal study distinguished between Insomnia Disorder and Perinatal Sleep Disruption and their sleep and mental health correlates. Methods 163 nulliparous females (age M±SD=33.35±3.42) participating in a randomised-controlled trial repeated the Insomnia Disorder module of the Duke Structured Interview for Sleep Disorders and PROMIS measures for sleep and mental health at 30 and 35 weeks’ gestation, and 1.5, 3, 6, 12, and 24 months postpartum (944 interviews, 1009 questionnaires completed). We compared clinical features when DSM-5 Insomnia Disorder criteria were: (1) met (Insomnia Disorder), (2) not met only because of the sleep opportunity criteria (Perinatal Sleep Disruption), and (3.) not met due to other criteria (Low Complaint). Results Proportions of Insomnia Disorder were 16.0% and 19.8% during early and late third trimester, and ranged 5.3-11.7% postpartum. If the sleep opportunity criteria were not considered, rates of Insomnia would be 2-4 times higher (21.4-40.4%) across time-points. Mixed effects models adjusting for covariates showed that compared to Low Complaint, both Insomnia Disorder and Perinatal Sleep Disruption scored significantly higher on insomnia and sleep disturbance scales, sleep effort, and sleep-related impairments (p-values<.01), but depression and anxiety were comparable (p-values>.12). Conclusion Assessing sleep complaints without considering sleep opportunity can result in over-diagnosis of Insomnia Disorder in the perinatal periods. Insomnia Disorder and perinatal sleep disruption were associated with adverse sleep and mood outcomes, and need to be carefully differentiated and appropriately addressed.

Acupoint stimulation-related therapies for the management of insomnia disorder: A systematic review and meta-analysis protocol

Review question / Objective: This meta-analysis will not only summarize all the ASRTs reported in clinical trials but also evaluate their effect on objective and subjective indices related to insomnia disorder. We will also perform subgroup analyses to identify possible confounders of the effects of ASRTs including treatment characteristics (e.g., acupoint selection, stimulation method, treatment duration) and patient characteristics (e.g., age, comorbidities, severity, and course of insomnia disorder). In doing so, we will endeavor to answer questions about whether efficacy varies according to the aspect of sleep targeted and whether the effects differ according to different modes of acupoint stimulation, acupoints applied, or specific types of insomnia, thereby providing the evidence to develop specific recommendations on prescribing ASRTs for insomnia disorder.

Differentiation Model for Insomnia Disorder and the Respiratory Arousal Threshold Phenotype in Obstructive Sleep Apnea in the Taiwanese Population Based on Oximetry and Anthropometric Features

Insomnia disorder (ID) and obstructive sleep apnea (OSA) with respiratory arousal threshold (ArTH) phenotypes often coexist in patients, presenting similar symptoms. However, the typical diagnosis examinations (in-laboratory polysomnography (lab-PSG) and other alternatives methods may therefore have limited differentiation capacities. Hence, this study established novel models to assist in the classification of ID and low- and high-ArTH OSA. Participants reporting insomnia as their chief complaint were enrolled. Their sleep parameters and body profile were accessed from the lab-PSG database. Based on the definition of low-ArTH OSA and ID, patients were divided into three groups, namely, the ID, low- and high-ArTH OSA groups. Various machine learning approaches, including logistic regression, k-nearest neighbors, naive Bayes, random forest (RF), and support vector machine, were trained using two types of features (Oximetry model, trained with oximetry parameters only; Combined model, trained with oximetry and anthropometric parameters). In the training stage, RF presented the highest cross-validation accuracy in both models compared with the other approaches. In the testing stage, the RF accuracy was 77.53% and 80.06% for the oximetry and combined models, respectively. The established models can be used to differentiate ID, low- and high-ArTH OSA in the population of Taiwan and those with similar craniofacial features.

Insomnia, Pre-Sleep Arousal, Psychosocial Factors and Changes in Sleep Pattern during the Second Wave Lockdown of the COVID-19 Pandemic in Georgia

Studies performed across the COVID-19 pandemic waves point to the persistent impact of the pandemic on sleep and mental health. We expand these data by examining insomnia, pre-sleep arousal, psychosocial factors, and retrospective changes in sleep pattern during the COVID-19 second wave lockdown period in Georgia. Data were collected through an online survey (n = 1117). The prevalence rate of probable insomnia disorder was 24.2%. Clinically relevant somatic and cognitive pre-sleep arousal was present in 49.8% and 58.0% of participants, and high levels of anxiety, depression and social isolation were found in 47.0%, 37.3%, 47.2% of respondents, respectively. We observed high prevalence rates of worse sleep quality, delayed bedtimes and risetimes, longer sleep latencies, higher awakenings and shorter sleep durations, relative to the pre-pandemic period. COVID-19-infected subjects showed more severe sleep and mental problems. Specific predictors differentially affected insomnia, somatic and cognitive pre-sleep arousal. Depression and COVID-19 infection emerged as vulnerability factors for pre-sleep arousal, which, in turn, wasassociated with a higher predisposition to insomnia disorder. We confirm the strong deteriorating impact of the COVID-19 pandemic on sleep and psychosocial well-being during the second wave lockdown period. The specific association between pre-sleep arousal, insomnia, and psychosocial factors is of clinical relevance for the prevention of severity and persistence of sleep and mental problems across the repeated lockdown/reopening waves. Modulation of pre-sleep arousal may prove beneficial to implement targeted interventions.

Alcohol Abuse and Insomnia Disorder: Focus on a Group of Night and Day Workers

The sleep-wake cycle plays a fundamental role in maintaining the physiological balance of our body. Its alteration favours the genesis of several organic alterations and diseases including sleep disorders and the consumption of several substances of abuse. It has been reported that the work activity, especially that carried out during the night, is able to influence the sleep-wake cycle, promoting the development of insomnia, which, in turn, would subject the worker to a stressful condition such as to encourage adverse behaviour such as the use/abuse of psychotropic substances. Based on the above premises, the aim of our research was to evaluate, in night workers: (i) the pattern of consumption of alcoholic beverages; (ii) the presence of insomnia; and (iii) the possible correlation between alcohol consumption and insomnia disorder. We used the AUDIT-C test (the abbreviated version of the Alcohol Use Disorders Identification Test) and the Insomnia Severity Index to assess alcohol consumption and insomnia disorder, respectively. All questionnaires were completed by workers of both sexes belonging to different types of work activities, exclusively day or night. The results of our research show a higher propensity of night workers to consume alcoholic beverages than those who work during daytime hours, often in binge-drinking mode. In addition, an increase in the amount of alcohol consumed was found to be related to insomnia disorder, especially in night workers. This study provides further awareness of the importance of the negative impact of alcohol consumption on sleep quality in night workers.

Efficacy of cognitive-behavioral therapy for insomnia: a group format implementation in the Spanish National Health System

Background. Cognitive-behavioral therapy for insomnia (CBT-i) is considered the first-line treatment for this disorder, but it is not widely implemented in clinical settings. This study aims to examine the efficacy of a CBT-i in group format in the Spanish National Health System. Method. Fifty-two participants with a Primary Insomnia Disorder (55.8% women; Mage = 47.19, SD = 11.02) were assigned to a CBT-i (n =17) or waiting list condition (n = 21). Treatment consisted of eight group format sessions (2 hours/week). Results. Significant improvements in insomnia severity, sleep quality, and insomnia-related dysfunctional beliefs and attitudes were observed in patients who received CBT-i. Emotional symptoms also decreased after the intervention in the CBT-i group. Conclusion. Findings support the efficacy of cognitive-behavioral therapy for insomnia with a group protocol for patients with primary insomnia disorder. The maintenance role of insomnia-related dysfunctional beliefs and attitudes in this disorder is also suggested.