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

Seiko Miyata,1,* Kunihiro Iwamoto,1,* Ippei Okada,1,* Akihiro Fujimoto,2 Yuki Kogo,2 Daisuke Mori,1,3,4 Manabu Amano,5 Nao Matsuyama,5 Kazuki Nishida,5 Masahiko Ando,5 Toshiaki Taoka,6 Shinji Naganawa,7 Norio Ozaki1,4 1Department of Psychiatry, Nagoya University, Graduate School of Medicine, Nagoya, Japan; 2Medical Headquarters, Eisai Co., Ltd., Tokyo, Japan; 3Brain and Mind Research Center, Nagoya University, Nagoya, Japan; 4Pathophysiology of Mental Disorders, Nagoya University, Graduate School of Medicine, Nagoya, Japan; 5Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan; 6Department of Innovative Biomedical Visualization (Ibmv), Nagoya University, Graduate School of Medicine, Nagoya, Japan; 7Department of Radiology, Nagoya University, Graduate School of Medicine, Nagoya, Japan*These authors contributed equally to this workCorrespondence: Seiko Miyata, Department of Psychiatry, Nagoya University, Graduate School of Medicine, 65 Tsurumai, Showa, Nagoya, Aichi, 466-8550, Japan, Tel +81 52 744 2282, Fax +81 52 744 2293, Email miyata.seiko.v4@f.mail.nagoya-u.ac.jpPurpose: 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 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.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.Keywords: insomnia, lemborexant, objective sleep evaluation, portable sleep EEG monitoring, subjective sleep evaluation