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Association Between Melatonin Receptor Agonists and Cardiac Arrhythmia; Disproportionality Analysis Studies Using
Rikuto Masuda1, Yoshihiro Noguchi2, Tomoaki Yoshimura3
1Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu-Shi, Gifu, 501-1196, Japan.
Cardiovascular Toxicology
|June 23, 2025
Summary
Melatonin receptor agonists show a weaker association with cardiac arrhythmia compared to benzodiazepine receptor agonists. This suggests potential cardioprotective effects of melatonin agonists in insomnia drug safety.
Area of Science:
- Pharmacovigilance and Cardiovascular Safety
- Drug-Induced Arrhythmias
- Regulatory Science
Background:
- Insomnia medications like benzodiazepine receptor agonists (BZRAs) are linked to cardiac arrhythmias.
- Melatonin receptor agonists (MRAs) may offer cardioprotective benefits.
Purpose of the Study:
- To investigate the association between MRA use and cardiac arrhythmia.
- To compare the cardiac safety profiles of MRAs and BZRAs.
Main Methods:
- Utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
- Analyzed data for cardiac arrhythmia using Standardized MedDRA Queries (SMQs).
- Calculated the Reporting Odds Ratio (ROR) to assess drug-event associations.
Main Results:
- MRAs demonstrated a negative correlation with all cardiac arrhythmia SMQs (e.g., "cardiac arrhythmias" ROR: 0.47).
- BZRAs showed a positive correlation with cardiac arrhythmia-related SMQs.
- Specific RORs for MRAs indicated reduced risk across various arrhythmia types.
Conclusions:
- MRA usage is weakly associated with cardiac arrhythmia, unlike BZRAs.
- MRAs may represent a safer alternative for insomnia treatment concerning cardiac events.
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