Miyata Seiko, Iwamoto Kunihiro, Okada Ippei, Fujimoto Akihiro, Kogo Yuki, Mori Daisuke, Amano Manabu, Matsuyama Nao, Nishida Kazuki, Ando Masahiko, Taoka Toshiaki, Naganawa Shinji, Ozaki Norio
Department of Psychiatry, Nagoya University, Graduate School of Medicine, Nagoya, Japan.
Medical Headquarters, Eisai Co., Ltd., Tokyo, Japan.
Nat Sci Sleep. 2024 Mar 19;16:291-303. doi: 10.2147/NSS.S448871. eCollection 2024.
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.
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.
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 repeated-multivariate 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.
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.
主观和客观评估对于失眠治疗均至关重要。仅基于主观评估显示，伦扎必利长期有效，且尚未在自然睡眠条件下评估长期客观指标。使用小型、轻便的睡眠脑电图（EEG）监测仪，而非多导睡眠监测，在伦扎必利治疗后4周和12周在家中客观评估睡眠情况。
根据《精神疾病诊断与统计手册》第五版，纳入患有失眠症的成人及老年受试者参与这项开放标签、单臂、单中心试验。前瞻性评估睡眠的客观和主观指标。使用问卷评估睡眠障碍、过度嗜睡和抑郁症状。
共筛选45名受试者，其中33名被纳入。进行配对t检验以评估睡眠变量的变化，并与基线进行比较；在接受伦扎必利治疗后的第4周和第12周，受试者的客观睡眠效率（SE）和主观睡眠参数有显著改善。考虑基线值时，重复多变量方差分析（MANOVA）显示客观指标有统计学显著变化。伦扎必利治疗三个月后，睡眠障碍、过度嗜睡和抑郁症状有所改善。
此外，在家中使用睡眠EEG监测进行客观测量时，伦扎必利治疗可改善夜间睡眠，并改善患有失眠症的老年人的日间嗜睡和抑郁症状。
