Adverse event reports of seizure for insomnia medication from 1967 to 2023

Adverse event reports of seizure for insomnia medication from 1967 to 2023

Abstract Insomnia may negatively impact seizure control; however, the corresponding evidence remains limited. This study analyzed the seizure risk associated with various insomnia medications using a comprehensive pharmacovigilance database and identified safe options for patients at high risk of se...

Full description

Saved in:
Bibliographic Details
Main Authors: Tae Hyeon Kim, Kyeongmin Lee, Jiyoung Hwang, Suhyun Lee, Hyesu Jo, Hanseul Cho, Hayeon Lee, Hye Jeong Baek, Jiseung Kang, Christa J. Nehs, Guillaume Fond, Laurent Boyer, Eun Kyoung Chung, Dong Keon Yon
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Scientific Reports
Subjects:
Insomnia
Seizure
World Health Organization
Pharmacovigilance
Online Access:https://doi.org/10.1038/s41598-025-11314-1
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Insomnia may negatively impact seizure control; however, the corresponding evidence remains limited. This study analyzed the seizure risk associated with various insomnia medications using a comprehensive pharmacovigilance database and identified safe options for patients at high risk of seizures. VigiBase, a database of adverse drug reaction reports from over 140 countries, comprises 35 million reports published from 1967 to 2023. Medications for insomnia include benzodiazepines, Z-drugs, antidepressants, atypical antipsychotics, first-generation H1 antagonists, orexin receptor agonists, melatonin, and melatonin receptor agonists. We assessed the association between insomnia medications and seizure risk by analyzing the reported odds ratio (ROR) with 95% confidence intervals (CI) and the information component (IC) with IC025. In total, 17,967 cases of seizures associated with insomnia medications were reported, revealing a significant association (ROR, 2.12 [95% CI, 2.09 to 2.15]; IC, 1.05 [IC025, 1.03]). Based on the mechanism of action, seizures were significantly associated with benzodiazepines (ROR, 2.56 [95% CI, 2.49 to 2.64]; IC, 1.34 [IC025, 1.29]), Z-drugs (ROR, 1.58 [1.49 to 1.69]; IC, 0.66 [0.56]), antidepressants (ROR, 2.52 [2.43 to 2.61]; IC, 1.32 [1.26]), atypical antipsychotics (ROR, 1.92 [1.88 to 1.97]; IC, 0.93 [0.89]), first-generation H1 antagonists (ROR, 2.08 [1.98 to 2.19]; IC, 1.05 [0.96]), and melatonin (ROR, 1.81 [1.49 to 2.20]; IC, 0.84 [0.51]). In contrast, orexin receptor antagonists (ROR, 0.81 [95% CI, 0.61 to 1.07]; IC, − 0.30 [IC025, − 0.77]) and melatonin receptor agonists (ROR, 1.20 [0.80 to 1.81]; IC, 0.26 [− 0.44]) showed no significant association with seizures. Although the disproportionality analysis did not allow causal interpretation, our study highlights significant variations in seizure signal among insomnia medications.
ISSN:2045-2322

Similar Items