BACKGROUND We report on the results of a Japanese postmarketing drug-use survey of suvorexant (Belsomra®) tablets. METHODS A survey with a ≤ 6-month observation period after the start of administration was conducted, targeting insomnia patients who were treated with suvorexant for the first time in Japan. Information on the safety and efficacy of the drug product was collected. The evaluation period was July 21, 2015-August 12, 2017, and the target number of patients was 3428. RESULTS The mean administration period for the safety analysis population of 3248 patients was 113 days. At 6 months after the start of treatment, 48.6% (1577/3248) of the patients had been continually receiving treatment, and 51.4% (1671/3248) of the patients discontinued/dropped out of treatment before 6 months. Among the patients who discontinued/dropped out of the treatment, more than 30% discontinued due to improvement. The mean treatment duration for those who had discontinued treatment for this reason was 62 days. The incidence rate of adverse drug reactions among those in the safety analysis population was 9.7%, and the common adverse drug reactions were somnolence (3.6%), insomnia (1.2%), dizziness (1.1%), and nightmare (0.8%), all of which are described in the product label. No additional noteworthy events were observed. In 2439 patients with a final overall global assessment of sleep judged by physicians, the 'improved' rate was 74.0%. Among 2424 patients who provided a final overall global assessment, the improvement rate was 73.2%, which was comparable with the improvement rate judged by physicians. Regarding clinical effects (based on patient diary data or physician's assessment), reduction in median sleep latency and increase in median total sleep time (reduction from 60 to 50 min and increase from 300 to 360 min compared with baseline, respectively) were observed at 1 week after the start of treatment and onwards, and the effect was maintained after the start of treatment for 6 months. A similar effect was observed irrespective of age groups or reasons for using suvorexant. CONCLUSION This survey was an exploratory observational study without a control group; the interpretation of results may require the consideration of factors that may have caused bias in the results, such as demographic characteristics and effects of other drugs. However, the results suggest that suvorexant can be a useful drug in daily clinical practice for treating insomnia.

中文翻译：

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Suvorexant（Belsomra®片剂10、15和20 mg）：日本药物使用结果调查。

背景技术我们报告了日本上市后对suvorexant（Belsomra®）片剂的药物使用情况调查的结果。方法对开始服用suvorexant的失眠患者进行调查，调查开始于给药后≤6个月。收集了有关药品安全性和有效性的信息。评价期为2015年7月21日至2017年8月12日，目标患者人数为3428名。结果安全性分析人群的3248名患者的平均给药期为113天。在开始治疗后的6个月内，有48.6％（1577/3248）的患者一直在接受治疗，而51.4％（1671/3248）的患者在6个月前停药/退出治疗。在停药/退出治疗的患者中，有超过30％的患者因病情好转而停药。由于这些原因而中止治疗的平均治疗时间为62天。安全性分析人群中药物不良反应的发生率为9.7％，常见的药物不良反应为嗜睡（3.6％），失眠（1.2％），头晕（1.1％）和噩梦（0.8％），所有这些都在产品标签中进行了描述。没有观察到其他值得注意的事件。在2439位经医生判断为最终总体睡眠总体评估的患者中，“改善”率为74.0％。在提供最终整体评估的2424名患者中，改善率为73.2％，与医生判断的改善率相当。关于临床效果（基于患者日记数据或医生的评估），在1时观察到中位睡眠潜伏期减少和中位总睡眠时间增加（分别从基线减少60分钟至50分钟和增加300分钟至360分钟）在开始治疗后的第一个星期及以后，并且在开始治疗后的6个月内保持效果。无论年龄组或使用suvorexant的原因如何，均观察到相似的效果。结论本调查是一项无对照组的探索性观察性研究。结果的解释可能需要考虑可能导致结果偏差的因素，例如人口统计学特征和其他药物的作用。然而，