The use of hypnotic drugs during the postpartum period in Japan remains unclear. This study investigated the use of hypnotic drugs during the first two weeks of the early postpartum period, including the reasons for prescription and the occurrence of adverse events. Patient backgrounds, hypnotic drug used, Edinburgh Postnatal Depression Scale (EPDS) scores, and adverse reactions were investigated retrospectively investigated using patient medical records. Of the 1893 puerperal women admitted during the study period, 52 (2.9%) used hypnotic drugs during the first two weeks postpartum and were included in the study. The mean age of the participants was 33.2 years, including 38 (73.1%) participants who underwent caesarean section deliveries. Insomnia and anxiety were the combined reasons for hypnotic drug use for 42 (80.8%) patients. Additionally, 48 patients used a single hypnotic drug, 2 patients used a combination of two drugs, and 2 patients changed from one hypnotic drug to another during the two-week period. Of the 56 drugs used, zolpidem was the most commonly used drug (n=35 (62.5%)), followed by brotizolam (n=10 (17.9%)), lenvorexant (n=6 (10.7%)), eszopiclone (n=3 (5.4%)), and suvorexant and etizolam (n=1 (1.8%)). Furthermore, 18 (42.9%) patients had an EPDS score of ≥9 at either the 2-week or 1-month follow-up visit. One case of infant apnea was observed in an infant of a patient prescribed zolpidem prior to delivery, and in one case of dizziness in a patient prescribed lenborexant. No other adverse effects were reported. Improved mother and child safety information and safer use of hypnotic drugs are desirable.

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The increase in national health care costs is a challenge arising from advances in medical care and an aging population. To control these costs, the government initiated the Selective Care System for brand-name drugs (long-listed products) with generic equivalents (GE) in October 2024. Therefore, we conducted a survey to examine changes in the GE usage rate in insurance pharmacies after the implementation of the Selective Care System, as well as the status of explanations of Selective Care by pharmacists. As a result, despite the fact that the total number of prescriptions has increased by approximately 7% year-on-year since October 2024, the GE utilization rate increased to 91.2% on average for all of the stores three months after the start of the Selective Care System, the largest ever. Regional differences in the GE use rate between Saitama and Tokyo showed a slight difference in regard to the process of the increase, but in Saitama, the GE use rate significantly increased year-on-year (p=0.034) from October 2024, when the Selective Care System started, and in Tokyo, the rate significantly increased year-on-year (p<0.001) two months later, thus indicating that the Selective Care System Both showed a significant increase from the previous year within three months of the start of the system. This suggested that the Selective Care System had an impact on GE usage. The GE usage rate may have been influenced not only by patients' concerns about rising out-of-pocket medical expenses due to the start of the system but also by pharmacists explaining the system and GE to approximately 2,500 patients who wanted to select brand-name drugs under the Selective Care System. Considering the constraints on healthcare finances, shifting the healthcare system to using GE, including AG, is desirable once brand name drug patents have expired.

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To identify determinants of the pharmacokinetic parameters for a total of 62 heart failure drugs and their active metabolites available in Japanese healthcare settings, data on the following pharmacokinetic parameters were collected from healthy adults: bioavailability (F), urinary excretion rate of unchanged drug (Ae), volume of distribution (Vd(p)), total body clearance (CLtot(p)), fraction unbound in plasma/serum (fuP), and blood-to-plasma drug concentration ratio (B/P). Complete data on F, Ae, Vd(p), CLtot(p), and fuP were available for 26 of the 62 drugs; however, data from official/semi-official sources in Japan were available for only 14 of the 26 drugs. To identify the determinants of clearance and volume of distribution, the clearance and volume of distribution values calculated from the whole blood drug concentrations are fundamental. The B/P required for the estimation was measured or estimated for 19 drugs. Both the determinants of clearance and volume of distribution were identified for 15 drugs. There were 26 binding-sensitive (S) drugs (fuP < 0.2) and 21 binding-insensitive (IS) drugs (fuP > 0.2). Of the S drugs, unbound drug concentrations or fuP values had been measured in pharmacokinetic studies conducted in patients with organ dysfunction for only 3 drugs (dapagliflozin, vericiguat, and tolvaptan). As for the IS drugs, pharmacokinetic studies in patients with organ dysfunction had been conducted for only 4 drugs. We found some problems in the “Precautions for use” section. One of these problems is a lack of information based on the specific results of pharmacokinetic studies for drugs for which dosing regimen adjustments are described from the viewpoint of pharmacokinetics.

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