Safety of brotizolam in hospitalized patients.

Purpose: The objective of this study was to evaluate the safety of brotizolam in hospitalized patients.

Methods: A single-center, comparative retrospective cohort analysis of patients hospitalized in internal medicine wards. Patients treated with brotizolam were compared to patients not treated with any benzodiazepines during hospitalization. Primary outcome was any of the following safety events: mechanical ventilation, delirium, and falls.

Results: Six hundred patients were included after exclusion in the final analysis; 300 treated with brotizolam (treatment) and 300 not treated with any benzodiazepines (comparator). The brotizolam-treated patients were older with more comorbidities and psychotropic medications. After adjustment using multivariate logistic regression analysis with propensity score, the primary outcomes occurred at significantly higher rates in treated patients than in untreated patients (17 vs. 2 events; OR = 7.33). Any psychotropic medication administered during hospitalization was found by logistic regression to be the main independent risk factor for the studied safety outcomes while age, comorbidities, and the cause of hospitalization were not.

Conclusions: Treatment with brotizolam during hospitalization in internal medicine wards is linked to a higher risk of respiratory deterioration, delirium, and falls. Use of psychotropic medications during hospitalization is the main independent risk factor of safety outcomes. Further research is needed to fully evaluate the risks and benefits of sleep induction medications in hospitals.