STUDY OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: 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.
STUDY OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: 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.
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Authors: S P Myrand; K Sekiguchi; M Z Man; X Lin; R-Y Tzeng; C-H Teng; B Hee; M Garrett; H Kikkawa; C-Y Lin; S M Eddy; J Dostalik; J Mount; J Azuma; Y Fujio; I-J Jang; S-G Shin; M R Bleavins; J A Williams; J D Paulauskis; K D Wilner Journal: Clin Pharmacol Ther Date: 2008-03-19 Impact factor: 6.875
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