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This page is an AI-assisted Turkish summary of the study presented at the 26th World Congress of Psychiatry. The study belongs to the presenting authors; please refer to the original source when citing it.

EV1269

Real-world data on the abuse potential of medications used to treat insomnia

REAL-WORLD DATA ON THE ABUSE POTENTIAL OF MEDICATIONS FOR THE TREATMENT OF INSOMNIA

In FAERS data, reporting rates for abuse-related events with dual orexin receptor antagonists are markedly lower than those for benzodiazepines, Z-drugs, and the non-controlled medications doxepin, ramelteon, and trazodone.

The analysis aimed to assess the real-world abuse potential of medications used to treat insomnia disorder using data from the FDA Adverse Event Reporting System (FAERS). The FAERS database was queried using the preferred terms (PTs) drug abuse, drug withdrawal, and drug dependence; the number of cases identified for each PT was divided by the total number of reported adverse events, and proportional reporting ratios (PRRs) and reporting odds ratios (RORs) were calculated. The reporting period extended from January 1, 2014, to March 31, 2024, providing ten years of pharmacovigilance experience covering the market availability of the DORA class; the medications examined included three DORAs, benzodiazepines (BZs), Z-drugs, and the non-controlled medications doxepin and ramelteon. An additional analysis was conducted for trazodone, the most frequently prescribed medication for insomnia in the United States. Based on modified Standardised MedDRA Query (SMQ) terms, the proportions were 18,690/67,584 (27.7%) for BZs approved across all indications, 659/2,868 (23.0%) for BZs approved for insomnia, 2,063/13,495 (15.3%) for Z-drugs, 262/9,963 (2.6%) for DORAs, 2,261/9,965 (22.7%) for trazodone, 525/2,358 (22.3%) for doxepin, and 25/314 (8.0%) for ramelteon. The PRR and ROR analyses in Figures 1 and 2 indicated that the number of real-world cases involving abuse, misuse, overdose, and other safety risks was significantly lower for the DORA class than for all Z-drugs, with the highest reporting odds observed for BZs; the individual PRR and ROR values in these figures were not legible at the poster's resolution. The introduction stated that approximately 12% of US adults are affected by insomnia and that the three DORAs approved in the United States (suvorexant, lemborexant, and daridorexant) showed no preclinical evidence of abuse potential and did not cause withdrawal or rebound insomnia in clinical studies. The authors concluded that the abuse potential of DORA medications was consistent with, and in some cases lower than, that of non-controlled medications, and that no DORA approved in the United States carries a drug dependence warning; the poster was first presented at World Sleep 2025.

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