Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder

Dash, Amitabh; Pinner, Kate; Inoue, Yuichi; Hayashida, Kentaro; Lim, Sung Chul; Yun, Chang-Ho; Lan, Tsuo-Hung; Huang, Chieh-Liang; Yardley, Jane; Naoki, Katsuhiko; Moline, Margaret

doi:10.1016/j.sleepx.2022.100044

Cited by 5 publications

(2 citation statements)

References 21 publications

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“…Although lemborexant represents a promising therapeutic option for the treatment of insomnia, better efficacy than that of suvorexant or other hypnotics has not been conclusively demonstrated. 187 Nevertheless, an improvement in both subjective and objective (PSG) sleep parameters has been reported also for lemborexant, with a good tolerance profile even in long-term treatment, absence of rebound effects in case of suspension, 190–193 and lack of changes of sleep cardio-respiratory parameters. 194 , 195 …”

Section: Discussionmentioning

confidence: 99%

“… 189 No rebound effect was observed in case of discontinuous intake or discontinuation of treatment, and adverse effects such as headache and drowsiness and upper respiratory airway infections were rare. 190–193 A good safety profile of lemborexant has also been demonstrated on respiratory parameters, such as the apnea-hypopnea index and the nocturnal oxygen saturation, 194 and on cardiac parameters, such as the QT interval. 195 Several trials with lemborexant have also shown little or no impairment of daily activities, such as cognitive performance, driving vehicles, and subjective sleepiness.…”

Section: Clinical Trials With Orexin Receptor Antagonists For Insomniamentioning

confidence: 97%

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Targeting Orexin Receptors for the Treatment of Insomnia: From Physiological Mechanisms to Current Clinical Evidence and Recommendations

Mogavero

Silvani

Lanza

et al. 2023

NSS

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After a detailed description of orexins and their roles in sleep and other medical disorders, we discuss here the current clinical evidence on the effects of dual (DORAs) or selective (SORAs) orexin receptor antagonists on insomnia with the aim to provide recommendations for their further assessment in a context of personalized and precision medicine. In the last decade, many trials have been conducted with orexin receptor antagonists, which represent an innovative and valid therapeutic option based on the multiple mechanisms of action of orexins on different biological circuits, both centrally and peripherally, and their role in a wide range of medical conditions which are often associated with insomnia. A very interesting aspect of this new category of drugs is that they have limited abuse liability and their discontinuation does not seem associated with significant rebound effects. Further studies on the efficacy of DORAs are required, especially on children and adolescents and in particular conditions, such as menopause. Which DORA is most suitable for each patient, based on comorbidities and/or concomitant treatments, should be the focus of further careful research. On the contrary, studies on SORAs, some of which seem to be appropriate also in insomnia in patients with psychiatric diseases, are still at an early stage and, therefore, do not allow to draw definite conclusions.

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Section: Discussionmentioning

confidence: 99%

Section: Clinical Trials With Orexin Receptor Antagonists For Insomniamentioning

confidence: 97%

Targeting Orexin Receptors for the Treatment of Insomnia: From Physiological Mechanisms to Current Clinical Evidence and Recommendations

Mogavero

Silvani

Lanza

et al. 2023

NSS

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2023 Guidelines on the Diagnosis and Treatment of Insomnia in Adults – Brazilian Sleep Association

Drager,

Assis,

Bacelar

et al. 2023

Sleep Sci

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Chronic insomnia disorder (simplified in this document as insomnia) is an increasingly common clinical condition in society and a frequent complaint at the offices of different areas of health practice (particularly Medicine and Psychology). This scenario has been accompanied by a significant evolution in treatment, as well as challenges in approaching patients in an appropriately way. This clinical guideline, coordinated by the Brazilian Sleep Association and the Brazilian Association of Sleep Medicine and counting on the active participation of various specialists in the area, encompasses an update on the diagnosis and treatment of insomnia in adults. To this end, it followed a structured methodology. Topics of interest related to diagnosis were written based on theoretical framework, evidence in the literature, and professional experience. As for the topics related to the treatment of insomnia, a series of questions were developed based on the PICO acronym (P – Patient, problem, or population; I – Intervention; C – Comparison, control, or comparator; O – Outcome). The work groups defined the eligible options within each of these parameters. Regarding pharmacological interventions, only the ones currently available in Brazil or possibly becoming available in the upcoming years were considered eligible. Systematic reviews were conducted to help prepare the texts and define the level of evidence for each intervention. The final result is an objective and practical document providing recommendations with the best scientific support available to professionals involved in the management of insomnia.

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Letter to the editor of “Behavioral Sleep Medicine”: Towards Standardization in the Reporting of Measures & Outcomes in Insomnia Randomized Controlled Trials

Muench,

Scott,

Cheung

et al. 2024

Behavioral Sleep Medicine

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Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder

Cited by 5 publications

References 21 publications

Targeting Orexin Receptors for the Treatment of Insomnia: From Physiological Mechanisms to Current Clinical Evidence and Recommendations

Targeting Orexin Receptors for the Treatment of Insomnia: From Physiological Mechanisms to Current Clinical Evidence and Recommendations

2023 Guidelines on the Diagnosis and Treatment of Insomnia in Adults – Brazilian Sleep Association

Letter to the editor of “Behavioral Sleep Medicine”: Towards Standardization in the Reporting of Measures & Outcomes in Insomnia Randomized Controlled Trials

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