ArticleFrontiers in pharmacology2025
Real-world disproportionality analysis of sleep disturbances associated with antiseizure medications in epilepsy: a pharmacovigilance study.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- The bidirectional relationship between epilepsy and sleep: a narrative review.Frontiers in neurology · 2026Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: Real-world evidence characterizing the safety profiles of antiseizure medications (ASMs) concerning sleep disturbances remains limited. This study aimed to systematically evaluate the reporting patterns and safety signals of ASMs-related sleep disturbances using data from the FDA Adverse Event Reporting System (FAERS). Methods: We conducted a retrospective pharmacovigilance study using FAERS data from Q1 2004 to Q2 2025. Disproportionality analyses were performed to identify potential safety signals for sleep-related adverse events (sAEs) associated with ASMs. We further analyzed demographic characteristics, clinical manifestations, and time-to-onset profiles. Results: Analysis of 3,118 reports identified significant associations between multiple ASMs and sleep disturbances. Significant signals were detected for sodium channel blockers eslicarbazepine, stiripentol, and cenobamate, as well as for mechanistically diverse agents vigabatrin, pregabalin, brivaracetam, and cannabidiol. The study characterized a broad spectrum of over 30 distinct sleep disturbances, among which insomnia was the most frequently reported preferred term (n = 1,570). Conclusion: This pharmacovigilance study reveals significant associations between various ASMs and sleep disturbances. The distinct disproportionality reporting profiles identified for some agents, which differ from prior evidence, necessitate careful clinical interpretation. Overall, this study elucidates the complex sleep safety profiles of ASMs, offering evidence to support more informed drug selection and monitoring in practice.
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