Literature DB >> 33506976

Change in the regulatory framework for zolpidem: What is the impact on the landscape of the prescription of sedative medications? The French national ZORRO study.

Marion Istvan1,2, Pascal Caillet1, Morgane Rousselet1,2, Marylène Guerlais1, Edouard-Jules Laforgue1,2, Marie Gérardin1, Pascale Jolliet1,2, Fanny Feuillet2,3, Caroline Victorri-Vigneau1,2.   

Abstract

AIMS: In recent years, zolpidem has been the subject of numerous reports of misuse, abuse and dependence. In view of these risks, the French drug agency (ANSM) decreed in April 2017 the implementation of secure prescription pads. The objective of this study was to evaluate the impact of this regulatory measure on the prescription of zolpidem and other sedative medications (zopiclone, benzodiazepines and antihistamines) in long-term users of zolpidem and associated factors.
METHODS: We performed a historical cohort study using data from the Generalist Sample of Beneficiaries (EGB). All patients aged over 18 years old who were long-term users (at least 3 months) before the measure were enacted. We analysed the reimbursement trajectories of zolpidem, zopiclone, benzodiazepines and antihistamines (hydroxyzine and alimemazine) up to 2 years after the measure using a state sequence analysis.
RESULTS: Overall, 2502 patients were analysed. A four-cluster typology was identified: continuation of zolpidem (n = 1044, 42%), discontinuation of sedative medications (n = 766, 31%), change to zopiclone (n = 537, 21%) and change to hypnotic benzodiazepines (n = 155, 6%). The most frequently prescribed hypnotic benzodiazepine was lormetazepam. We identified age, sex, treatment for psychiatric or addictive disorder and volume of zolpidem use before the measure as factors associated with different reimbursement trajectories after the regulatory change.
CONCLUSION: The regulatory change for zolpidem prescriptions reduced exposure to zolpidem among long-term users and also had a broad impact on prescriptions of other sedative medications. Switching to other medications that also present a potential risk of abuse or dependence should be carefully monitored.
© 2021 British Pharmacological Society.

Entities:  

Keywords:  benzodiazepines; hypnotics; pharmacoepidemiology; sedatives; state sequence analysis; zolpidem

Mesh:

Substances:

Year:  2021        PMID: 33506976     DOI: 10.1111/bcp.14753

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN: 0306-5251            Impact factor:   4.335


  3 in total

1.  Perception of the Regulatory Change for Zolpidem Prescription by French General Practitioners and Its Relation to Prescription Behavior.

Authors:  Edouard-Jules Laforgue; Marion Istvan; Benoit Schreck; Marie Mainguy; Pascale Jolliet; Marie Grall-Bronnec; Caroline Victorri-Vigneau
Journal:  J Clin Med       Date:  2022-04-13       Impact factor: 4.964

2.  Did the New French Regulation of Zolpidem Decrease the Problematic Consumption of Zolpidem? A Field Study among Users.

Authors:  Edouard-Jules Laforgue; Morgane Rousselet; Antoine Claudon; Aurélie Aquizerate; Pascale Jolliet; Marion Istvan; Caroline Victorri-Vigneau
Journal:  Int J Environ Res Public Health       Date:  2022-07-22       Impact factor: 4.614

3.  Use of State Sequence Analysis in Pharmacoepidemiology: A Tutorial.

Authors:  Jacopo Vanoli; Consuelo Rubina Nava; Chiara Airoldi; Andrealuna Ucciero; Virginio Salvi; Francesco Barone-Adesi
Journal:  Int J Environ Res Public Health       Date:  2021-12-20       Impact factor: 3.390

  3 in total

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