Department of Somnology, Tokyo Medical University, Tokyo, Japan.
Eisai Co., Ltd., Bunkyo-ku, Tokyo, Japan.
J Clin Sleep Med. 2021 May 1;17(5):1067-1074. doi: 10.5664/jcsm.9148.
Whether there are racial differences in the efficacy/safety of hypnotics has not been sufficiently investigated. We aimed to evaluate the efficacy/safety of lemborexant 5 mg and lemborexant 10 mg vs placebo once daily in a subset of Japanese patients with insomnia and to compare the results with those of non-Japanese patients.
This subanalysis reports the results of the first 6 months (period 1, placebo-controlled) of SUNRISE 2, a 12-month, global, randomized, double-blind, phase 3 study. Changes in patient-reported sleep onset latency, patient-reported sleep efficiency, and patient-reported wake after sleep onset with lemborexant 5 mg or lemborexant 10 mg vs placebo were evaluated. Treatment-emergent adverse events were evaluated for safety.
In total, 949 patients were randomized (Japanese, n = 161; non-Japanese, n = 788). Groups were balanced at baseline except for the male/female ratio (P = .0002) and body mass index (P < .0001) in the Japanese vs non-Japanese subgroups. Overall, the efficacy and safety of lemborexant were similar between subgroups. In the Japanese subgroup, the subjective sleep onset latency change from baseline was significant after 7 nights and 6 months with lemborexant 10 mg vs placebo, the subjective sleep efficiency change from baseline was significant after 7 nights with lemborexant 10 mg vs placebo, and the subjective wake after sleep onset change from baseline was significant at 6 months with lemborexant 5 mg vs placebo. The incidence and severity of treatment-emergent adverse events were consistent between both subgroups.
Lemborexant 5 mg and 10 mg improved sleep onset and sleep maintenance over 6 months and was well-tolerated in both the Japanese and non-Japanese patients. The safety profiles of lemborexant 5 mg and 10 mg were consistent between the subgroups.
Registry: ClinicalTrials.gov; Name: Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2); URL: https://clinicaltrials.gov/ct2/show/NCT02952820; Identifier: NCT02952820; and Registry: ClinicalTrialsRegister.eu; Identifier: 2015-001463-39.
催眠药的疗效/安全性是否存在种族差异尚未得到充分研究。我们旨在评估每日一次使用雷美替胺 5 毫克和 10 毫克与安慰剂相比，在一组患有失眠症的日本患者中的疗效/安全性，并将结果与非日本患者进行比较。
本亚分析报告了为期 12 个月的全球随机双盲 3 期 SUNRISE 2 研究的前 6 个月（第 1 期，安慰剂对照）的结果。评估雷美替胺 5 毫克或 10 毫克与安慰剂相比对患者报告的入睡潜伏期、患者报告的睡眠效率和患者报告的睡眠后觉醒的影响。评估治疗出现的不良事件的安全性。
共有 949 名患者被随机分配（日本组 161 例，非日本组 788 例）。两组在基线时平衡，除日本和非日本亚组的男性/女性比例（P=.0002）和体重指数（P <.0001）外。总体而言，雷美替胺的疗效和安全性在亚组间相似。在日本亚组中，雷美替胺 10 毫克与安慰剂相比，在第 7 天和第 6 个月时主观入睡潜伏期的变化具有统计学意义，雷美替胺 10 毫克与安慰剂相比，在第 7 天时主观睡眠效率的变化具有统计学意义，雷美替胺 5 毫克与安慰剂相比，在第 6 个月时主观睡眠后觉醒的变化具有统计学意义。两组之间治疗出现的不良事件的发生率和严重程度一致。
雷美替胺 5 毫克和 10 毫克可改善 6 个月的入睡和睡眠维持，在日本和非日本患者中均耐受良好。雷美替胺 5 毫克和 10 毫克的安全性特征在亚组间一致。
注册机构：ClinicalTrials.gov；名称：雷美替胺治疗失眠症的长期研究（SUNRISE 2）；网址：https://clinicaltrials.gov/ct2/show/NCT02952820；标识符：NCT02952820；和注册机构：ClinicalTrialsRegister.eu；标识符：2015-001463-39。
