Assessing the Real-World, Long-Term Impact of Lemborexant on Sleep Quality in a Home-Based Clinical Study

Purpose: Both subjective and objective evaluations are essential for the treatment of insomnia.Lemborexant has been shown to be effective in the long-term based solely on a subjective basis, and no long-term objective measures have been evaluated under natural sleep conditions.Small, lightweight sleep electroencephalogram (EEG) monitor was used, instead of polysomnography, to objectively evaluate sleep at home 4 and 12 weeks after lemborexant treatment.Patients and Methods: Adults and elderly subjects with insomnia disorder, per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, were enrolled in this open-label, single-arm, single-center trial.Objective and subjective measures of sleep were prospectively assessed.Sleep disturbance, excessive sleepiness, and depressive symptoms were assessed using questionnaires.Results: A total of 45 subjects were screened, of which 33 were enrolled.Paired t-tests were conducted to evaluate changes in sleep variables and compared with the baseline; subjects showed significant improvements in objective sleep efficiency (SE) and subjective sleep parameters at weeks 4 and 12 following treatment with lemborexant.When baseline values were taken into account, a repeatedmultivariate analysis of variance (MANOVA) revealed statistically significant changes in the objective measures.Sleep disturbance, excessive sleepiness, and depressive symptoms improved after three months of lemborexant treatment.Conclusion: Furthermore, lemborexant therapy improved nocturnal sleep, when measured objectively using sleep EEG monitoring at home, and improved daytime sleepiness and depressive symptoms in older adults with insomnia disorder.