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Objective To investigate whether zolpidem use is associated with suicide death in adults. Method We conducted a case–control study using the National Health Insurance Service‐National Sample Cohort (NHIS‐NSC) database. Cases were adults with a suicide record (ICD‐10 codes; X‐60‐X84, Y87.0) between January 1, 2004 and December 31, 2013. 10 Controls were matched to each case by age, sex, index year, region, income level, and health insurance type. Zolpidem use during 2 years before suicide was quantified. Adjusted odd ratios (aORs) with 95% confidence intervals (CIs) were estimated using conditional logistic regression. Results The percentage of zolpidem users was significantly higher in cases (451 of 1,928 [23.4%]) than in controls (832 of 18,404 [4.5%]). After controlling for potential confounders, zolpidem use was significantly associated with suicide (aORs, 2.09; 95% CI, 1.74–2.52). Dose–response relationships were observed (for trend, p < .0001). Consistent findings were observed when analyses were restricted to suicide death (aORs, 2.08; 95% CI, 1.73–2.51) and nonmedication poisoning suicide death cases (aORs, 2.10; 95% CI, 1.74–2.53). Conclusions We found a significant and positive association between zolpidem use and suicide. Zolpidem should be prescribed cautiously and with due caution of increased suicide risk.

The biomedical industry is making rapid progresses like never before, and the number of adverse events caused by implantable medical devices is also increasing. As such, there is an ever-growing need for post-market surveillance (PMS) procedures on implantable medical devices which ensure both the efficacy and safety of these devices. PMS systems of South Korea were compared to those of the United States (US) and the European Union (EU) -two regions that hold the largest shares in the medical devices market. Each regulatory authority examined in this paper follows a common structure consisting of regular follow-up and tracking procedures. This paper will focus on identifying similarities and differences between current PMS regulations on implantable medical devices in South Korea, the US, and the EU; through these comparisons, we propose strategies to improve the surveillance system currently available in South Korea.

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