Treatments For Chronic Insomnia Disorder Research Articles

Key results from two phase 3 trials on the efficacy and safety of daridorexant in patients with chronic insomnia disorder:a plain language summary

What is this summary about? This plain language summary describes the main results from two similar research studies, “Study 1” and “Study 2”, which evaluated the use of a medication called daridorexant in patients with chronic insomnia disorder. These two studies were phase 3 clinical trials, which compared different doses of daridorexant to an inactive pill called a placebo, which looked and tasted similar to the daridorexant pill but did not contain daridorexant or any other active ingredient. Important information about chronic insomnia disorder Adults with chronic insomnia disorder typically find it hard to fall or stay asleep and may wake up too early, leading to sleep dissatisfaction. They also have impaired daytime functioning, which is when a person can feel tired or drowsy, have difficulty concentrating, or experience low mood as a consequence of lack of sleep. Adults with chronic insomnia disorder are also at increased risk for injuries and accidents as a result of that impaired daytime functioning. What did the researchers find? Researchers found that daridorexant 50 mg and 25 mg improved on average participants' ability to get to sleep and stay asleep, as well as increasing their overall total sleep time. Daridorexant 50 mg also improved daytime functioning without any negative effects the next morning, such as feeling tired or drowsy, on average in the participants included in the studies. Why are these findings important? While available medications are effective in treating night-time symptoms of insomnia, they have not been shown to improve daytime symptoms in insomnia, and in many cases have been shown to have residual effects the next day due to their nature as sedatives. Therefore there has been a need for new treatments for chronic insomnia disorder that will improve both night-time and daytime symptoms with minimal next morning effects. These findings show the effectiveness of daridorexant 50 mg in improving both night-time and daytime functioning, and that daridorexant is well-tolerated at all doses. The results from these two studies resulted in the approval of the 25 mg and 50 mg doses of daridorexant by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Clinical Trial Registration: NCT03545191 (study 1) and NCT03575104 (study 2) ( ClinicalTrials.gov )

Effects of schedule exercise therapy on chronic insomnia.

Schedule exercise therapy (SET) is a novel nonpharmacological intervention for the treatment of chronic insomnia disorder (CID). The aim of this study was to explore the effects of SET on CID. Methods: One hundred and eighteen CID were recruited and randomized into medication (MED) or medication combined with SET (MSET) groups. Over 12 observational weeks, sleep and mood status were evaluated using the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), Self-rating Depression Scale (SDS), and Self-rating Anxiety Scale (SAS). At the end of the observational period, the rates of clinically effective hypnotic use were calculated. At 12 weeks, the PSQI progressively decreased for all subjects combined (P < .001) as well as ISI (P < .001), ESS (P < .001), SDS (P < .001), and SAS (P < .001). The decreases in PSQI (P < .05), ISI (P < .05), SDS (P < .01), and SAS (P < .05) in the MSET group were significantly larger than those in the MED group, but not the same as those in the ESS group (P > .05). At the trial endpoint, the clinically effective rate was significantly higher (P < .05) and the hypnotic usage rate was lower (P < .05) in the MSET group than in the MED group. SET may be an effective treatment for insomnia in patients with CID.

Development and acceptability of a mobile health application integrated with the electronic heath record for treatment of chronic insomnia disorder.

To describe the development and feasibility of a cognitive behavioral therapy for insomnia (CBT-I) program delivered via personal digital devices and fully integrated with the electronic health record (EHR). A multidisciplinary team of clinicians and members of our Center for Digital Health collaborated to develop a Chronic Insomnia Interactive Care Plan (ChI-ICP), an application that provides personalized and just in time education and promotes self-management using CBT-I concepts, and is activated from and fully integrated into the EHR. Following development, we evaluated patient engagement and workflows, assessed changes to provider workload, and examined outcomes on measures of insomnia during a pilot deployment of the application. A total of 222 patients were enrolled and 179 engaged with the plan during the 3-month pilot program. Enrolled patients generated an average of 3.9 ± 2.3 In Basket messages, most being automated notifications related to noncompletion of assigned tasks, while only a few were related to patients requesting additional training or help with insomnia. Sleep efficiency improved from baseline until the completion of the program from 74.5% ± 16.7% to 87.6% ± 10.8% (P = .001), and the Insomnia Severity Index improved from 14.9 ± 5.22 to 11.6 ± 4.80 (P = .006). In this pilot implementation of an integrated ChI-ICP, patient engagement was favorable, workflows and workload were not significantly burdensome for the care teams, and initial evaluation of efficacy was favorable. This provides evidence for an application that is a scalable method to assist patients with chronic insomnia and future work should assess its efficacy in controlled trials. Morgenthaler TI, Kolla BP, Anderson SE, etal. Development and acceptability of a mobile health application integrated with the electronic heath record for treatment of chronic insomnia disorder. J Clin Sleep Med. 2022;18(12):2785-2792.

0457 Development and utility of a mobile health application integrated with the electronic heath record for treatment of chronic insomnia disorder

Abstract Introduction Cognitive behavior therapy for insomnia (CBT-I), a first-line therapy for patients with chronic insomnia disorder (ChID), is underutilized due to reduced access to trained providers and other barriers. We developed an interactive care plan (ICP) combining individual aspects of CBT-I. This ICP, which integrates with the electronic health record (EHR), is designed to deliver personalized and scalable CBT-I to patients with ChID. We report data from initial implementation and evaluation of a ChID ICP deployed at a tertiary sleep medicine clinic. Methods The ICP was developed following patient and provider interviews and focus groups. Patients diagnosed with ChID were offered enrollment and engaged in the ICP through an app. The ICP has embedded logic that may escalate care or offer an exit from the program, depending upon the patient’s response to questions. Key variables ascertained from the patient included sleep efficiency (SE), sleep timing and the Insomnia Severity Index (ISI), and how satisfied they were with their progress (Likert scale). We also measured In Basket messaging related to use of the ICP. Results A total of 222 patients [57% female, age=56.4±15.9 years (average ±SD), 92.7% white] were enrolled in the initial 120 days of ICP implementation. Most referrals were initiated by physicians or advanced practitioners (77.9%). ISI at initiation was 15±5.18 and SE was 74.55±16.65%. Patients spent 35.9±26.25 days engaging with the ICP. The ISI score at 28 days was 12.89±4.98 and SE was 78.9±13.4% with both showing significant improvement from baseline (p=0.013; p=0.002; respectively). Self-rated satisfaction with progress did not significantly correlate with actual improvement in ISI or SE (p&amp;gt;0.05). The ICP generated 3.89±2.3 In Basket messages per patient. Conclusion Patients who actively engaged with the ICP showed significant improvements in insomnia severity and sleep efficiency. While a majority of the patients were neutral towards the ICP and only a small minority expressed dissatisfaction, these data indicate that the ICP will have clinical utility in busy sleep medicine practices with reduced access to behavioral sleep specialists. Support (If Any)

Abnormalities in Cutaneous Microcirculation in Patients with Alzheimer's Disease, Mild Cognitive Impairment, and Chronic Insomnia Disorder.

Impaired sympathetic response is frequently observed in neurodegenerative diseases, such as Alzheimer’s disease (AD). On the other hand, chronic insomnia disorder (CID) is also often accompanied by activation of sympathetic nerves. Considering that cutaneous microcirculation reflects sympathetic tone, we hypothesized that baseline cutaneous microcirculation in fingers, as detected by laser Doppler flowmetry (LDF), differs among patients with mild cognitive impairment (MCI), AD, and CID. As light therapy is one of the adjunctive treatments for AD and CID, we designed a randomized controlled cross-over trial of light therapy through eyes for 12 weeks with red light as treatment and green light as control limb, and examined if light therapy has an impact on cutaneous microcirculation. Before light therapy, patients with AD had significantly lower baseline cutaneous perfusion than those with CID in left and right first to fourth fingers. After red light therapy, however, cutaneous perfusion of fingers in CID patients significantly decreased (right fingers, before vs. after = 227.25 ± 62.00 vs. 162.00 ± 49.34, p = 0.007; left fingers, before vs. after = 228.99 ± 58.80 vs. 177.41 ± 59.41, p = 0.003) while cutaneous perfusion of fingers in CID patients did not significantly change after green light therapy. Light therapy with red light also significantly increased cutaneous finger perfusion in patients with AD (right fingers, before vs. after = 130.13 ± 49.82 vs. 172.38 ± 38.32, p = 0.043). Our results suggest that cutaneous perfusion is a useful tool to detect sympathetic dysfunction in patients with CID and AD, and that light therapy with red light is a potential therapeutic intervention to reverse impaired sympathetic function in patients with CID and patients with AD.

Endorsement of European guideline for the diagnosis and treatment of insomnia by the World Sleep Society

The European guideline for the diagnosis and treatment of insomnia (1) was developed by a task force of the European Sleep Research Society, which was composed of 27 experts with clinical experience on insomnia management from different European countries and the European Insomnia Network. The guideline focused on insomnia disorder as defined by ICD-10/ICSD-3. Its starting point was the previously published guideline by the German Sleep Society, which was revised and expanded based on a review of relevant meta-analyses of insomnia therapies published through June 2016. The scope of this guideline was to provide recommendations on the treatment of chronic insomnia disorder. This guideline was selected for review by the World Sleep Society (WSS) Insomnia Task Force and the WSS International Sleep Medicine Guidelines Committee. A task force of content experts from the WSS has reviewed this guideline specifically for its relevance and applicability to the practice of sleep medicine by sleep specialists that comprise its membership.

Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline.

This guideline establishes clinical practice recommendations for the use of behavioral and psychological treatments for chronic insomnia disorder in adults. The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine and sleep psychology to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. The task force evaluated a summary of the relevant literature and the quality of evidence, the balance of clinically relevant benefits and harms, patient values and preferences, and resource use considerations that underpin the recommendations. The AASM Board of Directors approved the final recommendations. The following recommendations are intended as a guide for clinicians in choosing a specific behavioral and psychological therapy for the treatment of chronic insomnia disorder in adult patients. Each recommendation statement is assigned a strength ("strong" or "conditional"). A "strong" recommendation (ie, "We recommend…") is one that clinicians should follow under most circumstances. A "conditional" recommendation is one that requires that the clinician use clinical knowledge and experience, and to strongly consider the patient's values and preferences to determine the best course of action. 1. We recommend that clinicians use multicomponent cognitive behavioral therapy for insomnia for the treatment of chronic insomnia disorder in adults. (STRONG). 2. We suggest that clinicians use multicomponent brief therapies for insomnia for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 3. We suggest that clinicians use stimulus control as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 4. We suggest that clinicians use sleep restriction therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 5. We suggest that clinicians use relaxation therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 6. We suggest that clinicians not use sleep hygiene as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL).

Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.

The purpose of this systematic review is to provide supporting evidence for a clinical practice guideline on the use of behavioral and psychological treatments for chronic insomnia disorder in adult populations. The American Academy of Sleep Medicine commissioned a task force of 9 experts in sleep medicine and sleep psychology. A systematic review was conducted to identify randomized controlled trials that addressed behavioral and psychological interventions for the treatment of chronic insomnia disorder in adults. Statistical analyses were performed to determine if the treatments produced clinically significant improvements in a range of critical and important outcomes. Finally, the Grading of Recommendations Assessment, Development, and Evaluation process was used to evaluate the evidence for making specific treatment recommendations. The literature search identified 1,244 studies; 124 studies met the inclusion criteria, and 89 studies provided data suitable for statistical analyses. Evidence for the following interventions is presented in this review: cognitive-behavioral therapy for insomnia, brief therapies for insomnia, stimulus control, sleep restriction therapy, relaxation training, sleep hygiene, biofeedback, paradoxical intention, intensive sleep retraining, and mindfulness. This review provides a detailed summary of the evidence along with the quality of evidence, the balance of benefits vs harms, patient values and preferences, and resource use considerations.

The Veterans Administration and Department of Defense clinical practice guidelines for the diagnosis and management of sleep disorders: what does this mean for the practice of sleep medicine?

In 2017 the Veterans Administration (VA) and Department of Defense (DOD) launched development of clinical practice guidelines (CPGs) for the diagnosis and treatment of sleep disorders, with the goal of informing and improving patient care. The guideline development process followed GRADE methodology, considering studies and systematic reviews published over the 10-year period prior to guideline development. A total of 41 recommendations were made,18 related to the diagnosis and treatment of obstructive sleep apnea (OSA) and 23 regarding chronic insomnia disorder. In contrast to other published guidelines, the VA DoD CPGs provide a comprehensive approach to diagnosis and management of the two most common sleep disorders, including a discussion of the sequencing of diagnostic approaches and treatment options. Regarding OSA, strong recommendations were made for follow-up evaluation after non-diagnostic home sleep apnea tests, positive airway pressure therapy as first-line treatment, and the incorporation of supportive, educational and behavioral interventions for patients at high risk for PAP therapy non-adherence due to comorbid conditions. Strong recommendations were also made for the use of cognitive-behavioral therapy for insomnia and against the use of kava (an herbal supplement) in the treatment of chronic insomnia disorder. These guidelines, while intended to directly inform care within VA and DOD, are broadly relevant to the practice of sleep medicine. The majority of scientific evidence was based on studies of non-military, non-veteran populations. The CPG is a major milestone for the VA and DOD in recognizing the importance of evidence-based treatments for sleep disorders in military personnel and veterans.

Insomnia.

This article provides updated information regarding the diagnosis and treatment of chronic insomnia disorder. In addition to discussing the latest recommendations regarding pharmacotherapeutic options for insomnia, this article also discusses the increased use of nonpharmacologic treatment approaches, including cognitive-behavioral therapy intervention, integrative medicine, mindfulness and meditation, and other therapeutic options in clinical practice. Insomnia is one of the most common sleep disorders in patients with other neurologic disorders. The definition and criteria for insomnia were updated with the release of the International Classification of Sleep Disorders, Third Edition. The American Academy of Sleep Medicine has updated clinical practice guidelines for the pharmacologic treatment of chronic insomnia in adults. New diagnostic and therapeutic options (eg, pharmacologic and behavioral therapies, at-home devices) have emerged to optimize and personalize the evaluation and management of sleep disorders such as insomnia. Although some of these devices and treatment options are still in the early stages of development, several are currently in clinical trials or will soon be available. This article emphasizes complexities related to the evaluation and management of patients with chronic insomnia disorder and describes alternative therapeutic options for patients with this common sleep disorder.

Treatment of chronic insomnia disorder in menopause: evaluation of literature.

Insomnia both as a symptom and as part of chronic insomnia disorder is quite common in menopause. Comorbid conditions, such as restless legs syndrome and obstructive sleep apnea, occur with high prevalence among perimenopausal women with insomnia. Insomnia in this population group is associated with adverse health outcomes, and there are no clear standards on how to treat it. Based on extensive literature search, 76 articles were identified. Two authors independently graded evidence according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Evaluation and treatment of other comorbid sleep disorders are recommended, as is cognitive-behavioral therapy for insomnia. Hormone therapy, eszopiclone, escitalopram, gabapentin, isoflavones, valerian, exercise, and hypnosis are suggested. Zolpidem, quiteiapine XL, citalopram, mirtazapine followed by long-acting melatonin, ramelteon, Pycnogenol, Phyto-Female Complex, yoga, and massage may be considered. Kampo formulas are not recommended. Acupuncture may not be suggested, and cognitive-behavioral therapy that is not tailored for insomnia probably should not be considered. Although a variety of interventions are shown to be helpful in improving sleep in menopause, there is a need for well-designed head-to-head trials with uniform outcome measures.