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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Neuropharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1436405

Data mining and safety analysis of dual orexin receptor antagonists (DORAs): a real-world pharmacovigilance study based on the FAERS database

Provisionally accepted
Manxue Jiang Manxue Jiang Hao Li Hao Li Lingti Kong Lingti Kong *
  • The first affiliated hospital of Bengbu medical university, Bengbu, Anhui Province, China

The final, formatted version of the article will be published soon.

    Objective: Using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, four signal detection methods were applied to mine adverse drug events (ADEs) related to use of dual orexin receptor antagonists (DORAs) to provide reference for safe clinical use.: Data collected from Q3rd 2014 to Q4th 2023 were obtained from the FAERS database. According to the preferred term (PT) and systematic organ classification (SOC) of MedDRA v.26.0, the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN) were used to detect ADE signals.Results: A total of 11,857 DORAs-related adverse reactions were detected, reported with suvorexant, lemborexant, and daridorexant as the main suspected drugs was 8717, 584, and 2556, respectively. A higher proportion of females than males were reported (57.27% vs 33.04%). The top 20 positive PT signals from three DORAs showed that "sleep paralysis" ranked first. "Brain fog" was stronger following daridorexant but was not detected for the other two drugs, and "sleep sex" and "dyssomnia" were stronger in suvorexant but not in the other two drugs. Additionally, some PTs occurred that were not included in drug instructions, such as "hangover" and "hypnagogic hallucination".In this study, four algorithms (ROR, PRR, BCPNN, and MGPS) were used to mine the safety signals of DORAs. We identified some potential ADE signals that can promote the rational use of DORAs and improve their safety.

    Keywords: Dual orexin receptor antagonists (DORAs), insomnia, FDA Adverse Event Reporting System, Adverse drug events, Data Mining

    Received: 22 May 2024; Accepted: 26 Jul 2024.

    Copyright: © 2024 Jiang, Li and Kong. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Lingti Kong, The first affiliated hospital of Bengbu medical university, Bengbu, Anhui Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.