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Association Between Hypnotics, Accidents, and Injuries: A Study Based on the Adverse Drug Event Reporting Database in
Rintaro Sogawa1, Masakazu Hatano2, Fumi Nishimura3
1Department of Pharmacy, Saga University Hospital, Nabeshima, Japan; sogawari@cc.saga-u.ac.jp.
Hypnotic drug use can increase accident risks. However, dual orexin receptor antagonists (DORAs) appear less associated with these events, offering safer sleep aid options.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Clinical Pharmacology
Background:
- Hypnotic drug use is linked to accidents and injuries.
- Limited data exists on this association after adjusting for confounding factors.
- This study investigates the relationship between hypnotic drug use and adverse events.
Purpose of the Study:
- To determine if hypnotic drug use is associated with accidents and injuries.
- To compare the risk of accidents and injuries across different classes of hypnotic medications.
- To provide evidence for safer hypnotic drug selection.
Main Methods:
- Analysis of 772,387 reports from the Japanese Adverse Event Reporting Database (September 2003–April 2004).
- Calculation of Reporting Odds Ratios (RORs) for accidents and injuries associated with hypnotic drugs.
- Multivariate analysis adjusting for age, sex, reporting year, and concomitant medications.
Main Results:
- 12,484 reports linked hypnotic drugs to accidents and injuries.
- Melatonin receptor agonists showed a decreased adjusted ROR (1.26).
- Dual orexin receptor antagonists (DORAs) showed a non-significant adjusted ROR (1.04), indicating a loss of signal for accidents and injuries.
Conclusions:
- The risk of accidents and injuries varies among hypnotic drugs.
- DORAs may be less frequently associated with accidents and injuries compared to other hypnotics.
- Findings aid in informed selection of hypnotic medications for patient safety.
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