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Objectives: The objectives of this study were to describe current sedative drug utilization patterns in critically ill patients undergoing mechanical ventilation (MV) in intensive care units (ICUs) in Japanese hospitals and to elucidate the relationship of these utilization patterns with patient clinical outcomes. Method: Analysis of hospital claims data derived from the Quality Indicator/Improvement Project identified 12,395 critically ill adult patients who had undergone MV while hospitalized in the ICUs of 114 Japanese hospitals and had been discharged between April 2008 and March 2010. Descriptive statistics were calculated for the daily utilization of sedative drugs, opioids, and muscle relaxants in this patient sample, and the relationship between drug utilization and patient outcomes using Cox proportional hazards analysis were examined. Results: Of the 12,395 patients included in the analysis, 7300 (58.9 %), 580 (4.7 %), and 671 (5.4 %) received sedative drugs, opioids, and muscle relaxants, respectively, for ≥2 days after intubation. Compared to the other patient groups, there was a higher proportion of males in the group given sedative drugs and the patients were significantly younger ( P < 0.001). Propofol was the most frequently used sedative drug, followed by benzodiazepines, barbiturates, and dexmedetomidine. The mortality rate was lower and ventilator weaning was earlier among patients who received only propofol than among those who received only benzodiazepines. Muscle relaxants were associated with increased duration of MV. Conclusions: This is the first study based on a large-scale analysis in Japan to elucidate sedative drug utilization patterns and their relationship with outcomes in critically ill patients. The most commonly used sedative was propofol, which was associated with favorable patient outcomes. Further prospective research must be conducted to discern effective sedative drug utilization. [ABSTRACT FROM AUTHOR]