EFFECTS OF JAPANESE POLICIES AND NOVEL HYPNOTICS ON LONG-TERM PRESCRIPTIONS OF HYPNOTICS

Abstract Background Long-term prescriptions of hypnotics is a worldwide problem. In Japan, medical fee reductions were implemented thrice between 2012 and 2018 to promote the appropriate use of hypnotics (2012 and 2014 for polypharmacy of three or more hypnotics, 2018 for long-term prescription of benzodiazepine receptor agonists for >12 months). However, the effect of medical fee revisions on long-term prescriptions of hypnotics has not been investigated to date. In addition to policies, novel hypnotics, such as melatonin receptor agonist (MRA) and orexin receptor antagonist (ORA), may also help resolve the problem of long-term prescriptions of hypnotics because they do not cause adverse effects, such as dependence or rebound insomnia, which make discontinuation of hypnotics difficult. However, it is unclear whether novel hypnotics reduce long-term prescriptions of hypnotics. Aims & Objectives This study aimed to examine the effect of Japanese policies for appropriate hypnotics use and novel hypnotics on long-term prescriptions of hypnotics. Method This retrospective study was conducted using a large-scale health insurance claims database. Among subscribers prescribed hypnotics at least once between April 2005 and March 2021, those prescribed hypnotics for the first time after being included in the database in three periods (period 1, April 2012– March 2013; period 2, April 2016– March 2017; and period 3, April 2018– March 2019) were eligible. These were set considering the timing of the 2014 and 2018 medical fee revisions. The duration of consecutive prescriptions of hypnotics over 12 months was evaluated. Factors associated with short-term prescriptions of hypnotics defined as discontinuation of hypnotics within 12 months were also investigated. Results In total, 186,535 participants were newly prescribed hypnotics. The mean duration of prescriptions was 2.9 months, and 9.3% of participants were prescribed hypnotics for 12 months. Prescription periods were not associated with short-term prescriptions of hypnotics. ORA use was associated with short-term prescriptions of hypnotics (adjusted hazard ratio, 1.077; 95% confidence interval, 1.035–1.120; p<0.001), but MRA use was not (adjusted hazard ratio, 0.986; 95% confidence interval, 0.945–1.028; p=0.506). Discussion & Conclusion Japanese policies had no statistically significant effect on long-term prescriptions of hypnotics. Compared to other countries, Japanese political intervention is weaker because of several loopholes. This may have contributed to the lack of the effect for long-term prescription of hypnotics. Although this study suggests that the initiation of ORA monotherapy for the treatment of patients with insomnia is a candidate strategy for preventing long-term prescription of hypnotics, caution is needed in interpreting these results because this study included several uncontrolled confounding factors. Future studies with sophisticated designs are needed to clarify whether ORA reduces long-term prescription of hypnotics.