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Introduction Optimal treatment of insomnia is uncommon, given the lack of awareness regarding insomnia management. While the treatment landscape for insomnia has evolved following the introduction of orexin receptor antagonists (ORA), few studies have examined prescribing patterns of hypnotics. We analyzed data from a claims database to examine real-world use of hypnotics in Japan. Methods Patients (aged ≥20 to <75 years old) with insomnia diagnosis, prescribed ≥1 hypnotic and continuous enrollment for ≥12 months before the index date were extracted from the JMDC claims database between April 1st, 2009 and March 31st, 2020. Patients were classified as new users of hypnotics or long-term users (prescribed the same mechanism of action [MOA] for ≥180 days). Trends (2010–2019) and patterns (2018–2019) in hypnotics prescriptions were analyzed. Results The analysis comprised of 130,177 new users and 91,215 long-term users (2010–2019). Nearly all new users (97.1%–97.9%) were prescribed a single MOA in each year. In 2010, almost all new users (94.0%) of hypnotics were prescribed GABAA-receptor agonists (benzodiazepines [BZD] or z-drugs). The proportions of patients prescribed BZD declined over time (from 54.8% in 2010 to 30.5% in 2019), whereas those prescribed z-drugs remained stable (~40%). The proportion of patients prescribed a melatonin receptor agonist increased slightly (3.2% to 6.3%), while those prescribed ORA increased substantially (0% to 20.2%). Among long-term users, the proportion of patients prescribed BZD steadily declined over time, but more than half were prescribed BZD. Unlike new users, a lower proportion of long-term users were prescribed ORA (0% in 2010, 4.3% in 2019). Analyses using 2018–2019 data showed that a combination of multiple (≥2) MOAs was prescribed to a higher proportion (18.2%) of long-term users than new users (2.8%). The prescription patterns of hypnotics were comparable among patients stratified by age, sex, medical specialty, and psychiatric comorbidities. Conclusion The present study showed distinct characteristics in the patterns and trends of the prescriptions of hypnotics among new users and long-term users in Japan. The high proportion of long-term BZD users suggests the need for educating clinicians about the optimal care pathway for insomnia. Support (If Any) MSD K.K., Tokyo, Japan

Background There is limited consensus regarding the optimal treatment of insomnia. The recent introduction of orexin receptor antagonists (ORA) has increased the available treatment options. However, the prescribing patterns of hypnotics in Japan have not been comprehensively assessed. We performed analyses of a claims database to investigate the real-world use of hypnotics for treating insomnia in Japan. Methods Data were retrieved for outpatients (aged ≥ 20 to < 75 years old) prescribed ≥ 1 hypnotic for a diagnosis of insomnia between April 1st, 2009 and March 31st, 2020, with ≥ 12 months of continuous enrolment in the JMDC Claims Database. Patients were classified as new or long-term users of hypnotics. Long-term use was defined as prescription of the same mechanism of action (MOA) for ≥ 180 days. We analyzed the trends (2010–2019) and patterns (2018–2019) in hypnotics prescriptions. Results We analyzed data for 130,177 new and 91,215 long-term users (2010–2019). Most new users were prescribed one MOA per year (97.1%–97.9%). In 2010, GABAA-receptor agonists (benzodiazepines [BZD] or z-drugs) were prescribed to 94.0% of new users. Prescriptions for BZD declined from 54.8% of patients in 2010 to 30.5% in 2019, whereas z-drug prescriptions remained stable (~ 40%). Prescriptions for melatonin receptor agonist increased slightly (3.2% to 6.3%). Prescriptions for ORA increased over this time from 0% to 20.2%. Prescriptions for BZD alone among long-term users decreased steadily from 68.3% in 2010 to 49.7% in 2019. Prescriptions for ORA were lower among long-term users (0% in 2010, 4.3% in 2019) relative to new users. Using data from 2018–2019, multiple (≥ 2) MOAs were prescribed to a higher proportion of long-term (18.2%) than new (2.8%) users. The distribution of MOAs according to psychiatric comorbidities, segmented by age or sex, revealed higher proportions of BZD prescriptions in elderly (new and long-term users) and male (new users) patients in all comorbidity segments. Conclusion Prescriptions for hypnotics among new and long-term users in Japan showed distinct patterns and trends. Further understanding of the treatment options for insomnia with accumulating evidence for the risk–benefit balance might be beneficial for physicians prescribing hypnotics in real-world settings.

Background Few studies have examined the prescribing patterns of orexin receptor antagonists (ORAs) in the real-world clinical setting in Japan. Objective We sought to analyze the factors associated with ORA prescriptions for patients with insomnia in Japan. Methods Outpatients (aged ≥ 20 to < 75 years old) prescribed one or more hypnotic for insomnia between April 1, 2018 and March 31, 2020 with continuous enrollment for ≥ 12 months were extracted from the JMDC Claims Database. We performed multivariable logistic regression to identify factors (patient demographics and psychiatric comorbidities) associated with ORA prescription in new or non-new users of hypnotics (patients without or with hypnotics prescription history, respectively). Results Of 58,907 new users, 11,589 (19.7%) were prescribed ORA at the index date. Male sex (odds ratio [OR] 1.17, 95% confidence interval [CI] 1.12-1.22) and presence of bipolar disorders (OR 1.36, 95% CI 1.20-1.55) were associated with greater odds of ORA prescription. Among 88,611 non-new users, 15,504 (17.5%) were prescribed ORA at the index date. Younger age and several psychiatric comorbidities, such as neurocognitive disorders (OR 1.64, 95% CI 1.15-2.35), substance use disorders (OR 1.19, 95% CI 1.05-1.35), bipolar disorders (OR 1.14, 95% CI 1.07-1.22), schizophrenia spectrum disorders (OR 1.07, 95% CI 1.01-1.14), and anxiety disorders (OR 1.05, 95% CI 1.00-1.10), were associated with greater odds of ORA prescription. Conclusion This is the first study to determine the factors associated with ORA prescriptions in Japan. Our findings could help guide appropriate insomnia treatment using ORAs.