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Evaluate changes in insomnia severity in subjects with moderate to severe insomnia (Insomnia Severity Index [ISI] score ≥15) treated for 12 months nightly with lemborexant.This phase 3 randomized study comprised two 6-month treatment periods. In Period 1, 949 subjects were randomized to placebo, lemborexant 5 mg (LEM5) or 10 mg (LEM10). In Period 2, placebo subjects were rerandomized to LEM5 or LEM10; subjects initially randomized to lemborexant continued their assigned treatment. Insomnia severity was assessed using baseline ISI and 1-, 3-, 6-, 9-, and 12-month post-treatment scores.Mean ISI scores improved significantly across treatment groups and disease severities, with greater decreases from baseline in the LEM5 and LEM10 versus placebo groups at months 1 (-7.1, -7.2, -5.2, respectively), 3 (-8.6, -8.9, -6.1, respectively), and 6 (-9.9, -9.8, -7.2 respectively); ISI score improvements were maintained with LEM5 and LEM10 at months 9 (-11.1 and -11.2, respectively) and 12 (-11.5 and -11.2, respectively). At months 1, 3, and 6, significantly more treatment responders (≥7-point ISI score decrease from baseline) were observed with LEM5 (44%-57%) and LEM10 (44%-52%) versus placebo (30%-41%). At months 1, 3, and 6, more remitters (ISI total score10 and 8) were observed with LEM5 (30%-44% and 22%-34%, respectively) and LEM10 (31%-41% and 22%-31%, respectively) versus placebo (18%-28% and 11%-21%, respectively).Lemborexant significantly reduced insomnia severity for 12 months and increased clinically meaningful response and remission rates versus placebo.ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.

Background Though insomnia is associated with affected emotion regulation and dysfunctional ideas about sleep, little is known about the relation of these problems with objective sleep disruption. We aimed to explore this relationship in young adults with and without insomnia. Methods Twenty young adults with diagnosed insomnia disorder (aged 27.7 ± 8.6 years) and twenty age-matched individuals without insomnia (26.7 ± 7.0 years) completed questionnaires, measuring sleep-related thoughts and emotions and emotion regulation. Objective sleep measurements were collected through 10-days actigraphy as a representative sample of nights, and analyzed for sleep onset latency, sleep efficiency total sleep time. T-tests and multivariate analyses of variance (MANOVA) were conducted for sample characterization and analysis of the association of sleep-related thoughts and emotions and emotion regulation with objective sleep data. Results As expected, young people showed more dysfunctional sleep-related thoughts and emotions (all ps ≤ 0.025) and dysfunctional emotion regulation strategies (all ps ≤ 0.040). Surprisingly, MANOVA results showed that only emotion coping strategies after a stressful event (p = 0.017) and dysfunctional beliefs about sleep (p = 0.012), but not other factors of arousal or sleep reactivity, were associated with overall worse sleep, especially sleep onset latency (all ps ≤ 0.012) and sleep efficiency (all ps ≤ 0.010). Conclusions Maladaptive emotion coping strategies after a stressful event and dysfunctional sleep-related beliefs and attitudes affect objective sleep onset latency and sleep efficiency in young adults, highlighting the importance of targeting these features in the prevention and treatment of chronic insomnia and improving actual sleep quality.

International audience; Objective/BackgroundMandibular repositioning device (MRD) therapy is an alternative to continuous positive airway pressure (CPAP). The ORCADES study is assessing the long-term efficacy and tolerability of MRD therapy in OSAS; 2-year follow-up data are presented.Patients/MethodsOSAS patients who refused or were noncompliant with CPAP were fitted with a custom-made computer-aided design/computer-aided manufacturing (CAD/CAM) bi-block MRD (ResMed, Narval CC™); mandibular advancement was individually titrated. Sleep and respiratory parameters were determined at baseline, 3–6 months, and two years. The primary endpoint was treatment success (percentage of patients achieving a ≥50% reduction in the apnoea-hypopnoea index [AHI]).ResultsOf 315 enrolled patients, 237 remained on MRD treatment at two years, and 197 had follow-up data. The treatment success rate at two years was 67%; AHI

Suvorexant is an orexin receptor antagonist that is approved in the US, Japan and Australia for the treatment of insomnia. Using outcomes from the Insomnia Severity Index (ISI) in the core registration studies, we explored suvorexant effects on sleep problems and their impact on daytime function.Data were pooled from two similar Phase 3, randomized, double-blind, placebo-controlled, parallel-group, three-month trials in elderly (≥65 years) and non-elderly (18-64 years old) insomnia patients. Age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg were evaluated. The ISI, a 7-item self-rated questionnaire with each item rated on 0-4 scale (higher score corresponds to increasing severity), was administered to patients as an exploratory assessment in both studies at baseline and one and three months after randomization.The analysis included 1824 patients. Suvorexant improved change-from-baseline ISI total scores to a greater extent than placebo (Month three: 20/15 mg = -6.2, 40/30 mg = -6.7, placebo = -4.9, p-values for both active arms vs. placebo0.001) and resulted in a greater proportion of responders than placebo using a variety of definitions (eg, ≥6-point improvement from baseline at Month three: 20/15 mg = 55.5%, 40/30 mg = 54.9%, placebo = 42.2%, p-values for both active arms vs. placebo0.001). Additionally, the "impact of insomnia" component, which assesses the impact of insomnia on daytime function/quality-of-life, was improved to a greater extent by suvorexant than placebo.Suvorexant 20/15 mg and 40/30 mg improved sleep to a greater extent than placebo as assessed by the ISI in patients with insomnia. Improvement in sleep onset/maintenance as well as a reduction of the impact of sleep problems on daytime function contributed to the overall improvement observed in ISI total score. CLINICALTRIALS.NCT01097616, NCT01097629.