Benzodiazepines and Z drugs: descriptive analysis of reported paradoxical reactions.

• Grant number: 24/01655-5
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: May 01, 2024
• End date: April 30, 2025
• Field of knowledge: Health Sciences - Nursing - Psychiatric Nursing
• Principal Investigator: Maria Olívia Barboza Zanetti
• Grantee: Rafaela Lourenço Spoti
• Host Institution: Escola de Enfermagem de Ribeirão Preto (EERP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

Benzodiazepine medications have been widely used by the global population for the treatment of anxiety, sleep, and mood disorders. The same applies to Z drugs for managing insomnia. However, these medications can trigger a range of adverse reactions, such as dependence, tolerance, cognitive changes, and paradoxical reactions. Such reactions are poorly explored in the scientific literature. Therefore, the current research project aims to assess reports of paradoxical reactions to benzodiazepine medications and Z drugs. It is a cross-sectional descriptive study in which open data from the Brazilian spontaneous reporting system (Vigimed) will be analyzed. The data will include safety reports of individual cases of benzodiazepine or Z drug users who experienced Adverse Drug Events (ADEs) indicative of paradoxical reactions and were reported in Vigimed between January 2018 and April 2023. A MedDRA terminology will be used to classify ADEs, presented by System-Organ-Class (SOC) and Preferred Term (PT). Reporting Odds Ratio (ROR) analysis will be conducted to confirm potential associations. The results are expected to enhance understanding of the identification of paradoxical effects with benzodiazepines and Z drugs and to examine the relationship between paradoxical reactions and age and gender.