Nantes Université, CHU Nantes, Service de Pharmacologie Clinique - Centre d'Evaluation et d'Information sur la Pharmacovigilance-Addictovigilance, Nantes, France.
Nantes Université, Univ Tours, CHU Nantes, INSERM, MethodS in Patient-centered outcomes and HEalth ResEarch, SPHERE, Nantes F-44000, France.
Eur J Public Health. 2023 Apr 1;33(2):169-175. doi: 10.1093/eurpub/ckad003.
Since the appearance of zolpidem on the market, the occurrence of serious cases of abuse, misuse and dependence have come to the attention of authorities. In view of the increase in the number and severity of cases among zolpidem users and the predominant presence of zolpidem in falsified prescriptions, the French Health Authorities implemented part of the narcotics regulation for zolpidem in April 2017. The objective of this article was to describe the evolution of the abuse, dependence and misuse of zolpidem.
We used three data sources: (i) zolpidem is a reimbursable and strictly prescription drug in France. Medic'AM is a public database that indicates the number of tablets reimbursed each month in France for each reimbursable drug. This database has been analyzed as a proxy of the exposure of the French population to zolpidem; (ii) all French cases of drug dependence or abuse reported by health professionals (regulatory obligation) and (iii) an epidemiological tool based on the surveillance of falsified prescriptions over two periods: the 3-year period before the regulatory measure (2014-16) and the 3-year period after the regulatory measure (2018-20).
This regulatory change had two immediate consequences: a sharp decline in falsified prescriptions and a decrease of ∼57% between the two study periods in the zolpidem reimbursement data. Markers of problematic consumption remained after the regulatory change with worsening cases, particularly for people who were genuinely dependent and/or had comorbidities or misusers for whom zolpidem was the substance of interest, whose proportion increased significantly in the addictovigilance notification system, from 43.6% (N = 107) to 59.3% (N = 127) (P < 0.01).
Further monitoring is needed in light of these persistent markers of problematic consumption.
自唑吡坦上市以来，其严重滥用、误用和依赖的情况已引起相关部门的关注。鉴于唑吡坦使用者的数量和严重程度的增加，以及伪造处方中唑吡坦的主要存在，法国卫生当局于 2017 年 4 月对唑吡坦实施了部分麻醉品管制。本文的目的是描述唑吡坦滥用、依赖和误用的演变。
我们使用了三种数据源：（i）唑吡坦在法国是一种可报销的处方药。Medic'AM 是一个公共数据库，它显示了法国每个月为每种可报销药物报销的片剂数量。该数据库被分析为法国人口接触唑吡坦的代理；（ii）所有由卫生专业人员报告的药物依赖或滥用的法国病例（监管义务）；（iii）基于两个时期的伪造处方监测的流行病学工具：监管措施前的 3 年期间（2014-16 年）和监管措施后的 3 年期间（2018-20 年）。
这一监管变化有两个直接后果：伪造处方数量急剧下降，在两个研究期间，唑吡坦报销数据下降了约 57%。在监管变化后，仍有问题消费的迹象，特别是对真正依赖者和/或有合并症或滥用者而言，他们的比例在药物监测通知系统中显著增加，从 43.6%（N=107）增加到 59.3%（N=127）（P<0.01）。
鉴于这些持续存在的问题消费标志物，需要进一步监测。
