Abstract

Our objective was to quantify the impact on the use of zolpidem of the obligation implemented in France in 2017 to use secure prescription pads to prescribe it. We conducted a cohort study within the French SNDS healthcare database. Patients aged over 18 years of age were considered for inclusion. The number of prevalent users and incident episodes of zolpidem use were compared before the change in law (July 1, 2016 to January 1, 2017) and after (July 1, 2017 to January 1, 2018). A prevalent user was a patient who has been reimbursed for zolpidem at least once. An incident episode of zolpidem use was defined by a first administration of zolpidem without any prior administration within the previous six months. Regarding prevalence of zolpidem users, we observed a decrease from 2.79% (CI95%:2.75-2.83) to 1.48% (1.44-1.51), with a number of patients who stopped taking it after the change in law being approximately 4.3 times higher than the number of patients who started. We observed a negative association between the post-law change period (OR = 0.52 (0.51-0.53)) and the probability of receiving zolpidem, adjusting for sex, aging, low income and chronic disease. We observed a decrease from 183 treatment episodes per 100,000 insured months on average to 79 episodes per 100,000 insured months, with an incidence rate ratio (IRR) equal to 0.43 (0.38-0.49). The use of secure prescription pads seems to have reduced the exposure of the French population to zolpidem.

Highlights

  • A hypnotic drug marketed in France since 1987 (Stilnox1) is an imidazopyridine which binds to the benzodiazepine binding site on the GABA-A receptors

  • The study was founded by a grant from the ANSM (AAP-2017-027) and was monitored by a pluridisciplinary steering committee with pharmacologists, psychiatrists specialized in addiction, pharmacoepidemiologist and general practioners (GP)

  • Albeit an overall increase in the population size is observed, the characteristics remained similar between the two periods, with a population showing a sex ratio of 0.96, aged 41 years on average at inclusion, one sixth benefiting from the ALD scheme and 6% benefiting from a CMUc scheme

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Summary

Introduction

A hypnotic drug marketed in France since 1987 (Stilnox1) is an imidazopyridine which binds to the benzodiazepine binding site on the GABA-A receptors. It is highly selective for the α1 subtype receptor and initial clinical trials reported no evidence of abuse or dependence [1,2]. Zolpidem has been marketed as a safer drug than benzodiazepines, regarding dependence issues. The first case report describing dependence on zolpidem appeared in the literature in 1993 [3].

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