0444 Adverse Effects of Supratherapeutic Dosing of Zolpidem in Female Patients

Abstract Introduction Zolpidem is a commonly prescribed FDA- approved hypnotic. In 2013, the FDA recommended reducing maximum dosing of zolpidem in female patients due to concern for slower elimination time as compared to their male counterparts. Despite this, none of the FDA warnings or communications cited published studies that support the claim that women are at increased risk of adverse events. Subsequent prescribing data has shifted to reflect FDA recommendations. In this study we examined risks of using above FDA recommended doses in female patients. Methods This is a retrospective chart review including all adult female patients (> 18 years old) evaluated and managed at the Mayo Clinic Center for Sleep Medicine between 1/1/2024 to 12/31/2024. Detailed review of Mayo Clinic’s EMR was accomplished with subjects on zolpidem split into supratherapeutic and non-supratherapeutic dosing groups. Subjects were relegated to the above maximum dose group if they were ever prescribed FDA-defined supratherapeutic dosing (>5 mg IR formulation or >6.25 mg ER formulation) for a >1 week period. Adverse events were defined as: falls, parasomnias, and cognitive impairment determined via ICD-10-CM codes that occurred at any period following zolpidem initiation. We analyzed rates of adverse effects using chi-square test of independence and Fischer’s exact test in patients with or without supratherapeutic dosing. Results 435 female patients met inclusion criteria. Among the demographic characteristics, only weight was associated with receiving a higher dose of zolpidem (P< 0.001). There were similar rates of adverse effects in both dosing groups with 11.4% of female patients on supratherapeutic dosing as compared to 10.9% of female patients on non-supratherapeutic dosing reporting adverse effects (chi-square test of independence (X2=6.5, N=435, p=0.99) or Fischer’s exact test (OR=1.05, p=0.87). Conclusion Overall, there was not a significant difference in rates of adverse events in female patients receiving supratherapeutic vs non-supratherapeutic doses of zolpidem during the time frame described. Further studies are warranted to better elucidate longitudinal risk of adverse effects related to gender-related differences with zolpidem dosing. Support (if any)