摘要
Abstract
Objective:To delve deeply into and assess the gender differences in adverse drug reaction(ADR)signals associated with zolpidem,aiming to provide gender-based rational drug use guidance and references for clinical practice and promote safe and effective drug therapy.Methods:Using data from the FDA adverse event reporting system(FAERS)database spanning from January 2004 to March 2024,reports of adverse events(AEs)associated with zolpidem were retrieved.The reporting odds ratio(ROR)method was employed for signal detection,with a specific focus on analyzing the signal intensity of gender-related differences.Results:A total of 11 289 female and 7 470 male patients with zolpidem as the primary drug were included in this study.Signal mining identified 32 positive signals,16 for each gender.Analysis revealed that females were more likely to experience adverse reactions such as crying,chills,migraine,urticaria,arthralgia,pruritus,abdominal discomfort,paraesthesia,bradypnoea,diarrhoea,abdominal pain upper,hypoaesthesia,weight decreased,exposure during pregnancy,contusion,and palpitations.Conversely,adverse reactions more frequently observed in males included hereditary ataxia,parasomnia,homicide,physical assault,delusion,delirium,anterograde amnesia,incoherent,oedema peripheral,increaing of blood creatine phosphokinase and alanine aminotransferase.Furthermore,adverse events such as product administration error,accidental exposure to product,wrong product administered,and self-medication were also found to be more prevalent among males.Conclusion:Sig-nificant sex-related differences in zolpidem-associated adverse drug reactions(ADRs).Female patients demonstrated higher susceptibility to emotional disturbances and dermatological reactions,suggesting cautious use of high-dose zolpi-dem in this population.Male patients required particular vigilance for monitoring violent behaviors and cognitive impair-ments.These findings underscore the clinical importance of sex-specific risk assessment in zolpidem pharmacotherapy.关键词
唑吡坦/不良事件/报告比值比法/性别差异/药物警戒Key words
Zolpidem/Adverse event/Reporting odds ratio method/Sex-related diffeence/Pharmacovigilance分类
医药卫生
