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.
benzodiazepines
hypnotics
pharmacoepidemiology
sedatives
state sequence analysis
zolpidem
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
08 2021
08 2021
Historique:
revised:
12
01
2021
received:
13
10
2020
accepted:
18
01
2021
pubmed:
29
1
2021
medline:
28
10
2021
entrez:
28
1
2021
Statut:
ppublish
Résumé
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. 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. 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. 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.
Substances chimiques
Hypnotics and Sedatives
0
Benzodiazepines
12794-10-4
Zolpidem
7K383OQI23
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3310-3319Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2021 British Pharmacological Society.
Références
ANSM: Agence nationale de sécurité du médicament et des produits de santé. Etat des lieux de la consommation des benzodiazépines - Point d'Information. Published online April 2017. Accessed January 7, 2021. https://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Etat-des-lieux-de-la-consommation-des-benzodiazepines-Point-d-Information
Holm KJ, Goa KL. Zolpidem: an update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs. 2000;59(4):865-889. https://doi.org/10.2165/00003495-200059040-00014
Victorri-Vigneau C, Dailly E, Veyrac G, Jolliet P. Evidence of zolpidem abuse and dependence: results of the French Centre for Evaluation and Information on Pharmacodependence (CEIP) network survey. Br J Clin Pharmacol. 2007;64(2):198-209. https://doi.org/10.1111/j.1365-2125.2007.02861.x
Victorri-Vigneau C, Gérardin M, Rousselet M, Guerlais M, Grall-Bronnec M, Jolliet P. An update on zolpidem abuse and dependence. J Addict Dis. 2014;33(1):15-23. https://doi.org/10.1080/10550887.2014.882725
Schonmann Y, Goren O, Bareket R, Comaneshter D, Cohen AD, Vinker S. Chronic hypnotic use at 10 years-does the brand matter? Eur J Clin Pharmacol. 2018;74(12):1623-1631. https://doi.org/10.1007/s00228-018-2531-4
Victorri-Vigneau C, Feuillet F, Wainstein L, et al. Pharmacoepidemiological characterisation of zolpidem and zopiclone usage. Eur J Clin Pharmacol. 2013;69(11):1965-1972. https://doi.org/10.1007/s00228-013-1557-x
Schifano F, Chiappini S, Corkery JM, Guirguis A. An insight into Z-drug abuse and dependence: an examination of reports to the European Medicines Agency database of suspected adverse drug reactions. Int J Neuropsychopharmacol. 2019;22(4):270-277. https://doi.org/10.1093/ijnp/pyz007
Griffiths RR, Johnson MW. Relative abuse liability of hypnotic drugs: a conceptual framework and algorithm for differentiating among compounds. J Clin Psychiatry. 2005;66(Suppl 9):31-41.
Chiappini S, Schifano F. What about “pharming”? Issues regarding the misuse of prescription and over-the-counter drugs. Brain Sci. 2020;10(10):736. https://doi.org/10.3390/brainsci10100736
Jouanjus E, Guernec G, Lapeyre-Mestre M, French Addictovigilance Network. Medical prescriptions falsified by the patients: a 12-year national monitoring to assess prescription drug diversion. Fundam Clin Pharmacol. 2018;32(3):306-322. https://doi.org/10.1111/fcp.12356
Caillet P, Rousselet M, Gerardin M, Jolliet P, Victorri-Vigneau C. Prevalence of zolpidem use in France halved after secure prescription pads implementation in 2017: A SNDS database nested cohort study. PLoS One. 2020;15(2):e0228495. https://doi.org/10.1371/journal.pone.0228495
Touchard J, Sabatier P, Airagnes G, Berdot S, Sabatier B. Consequences of the new zolpidem prescription regulations: a cohort study from the French national healthcare database. Eur J Clin Pharmacol. 2019;76(1):89-95. https://doi.org/10.1007/s00228-019-02737-7
Bezin J, Duong M, Lassalle R, et al. The national healthcare system claims databases in France, SNIIRAM and EGB: Powerful tools for pharmacoepidemiology. Pharmacoepidemiol Drug Saf. 2017;26(8):954-962. https://doi.org/10.1002/pds.4233
Base de données publique des médicaments. Published 2020. Accessed January 7, 2021. http://base-donnees-publique.medicaments.gouv.fr/
Gérardin M, Rousselet M, Caillet P, et al. French national health insurance database analysis and field study focusing on the impact of secure prescription pads on zolpidem consumption and sedative drug misuse: ZORRO study protocol. BMJ Open. 2019;9(6):e027443. https://doi.org/10.1136/bmjopen-2018-027443
Gabadinho A, Ritschard GS, Müller N, Studer M. Analyzing and visualizing state sequences in R with TraMineR. J Stat Softw. 2011;40(4):1-37. https://doi.org/10.18637/jss.v040.i04
Le Meur N, Gao F, Bayat S. Mining care trajectories using health administrative information systems: the use of state sequence analysis to assess disparities in prenatal care consumption. BMC Health Serv Res. 2015;15(1):200. https://doi.org/10.1186/s12913-015-0857-5
Roux J, Grimaud O, Leray E. Use of state sequence analysis for care pathway analysis: The example of multiple sclerosis. Stat Methods Med Res. 2019;28(6):1651-1663. https://doi.org/10.1177/0962280218772068
R Core Team. R: A language and environment for statistical computing. Vienna, Austriahttps://www.R-project.org/: R Foundation for Statistical Computing; 2020.
Alexander SPH, Mathie A, Peters JA, et al. THE CONCISE GUIDE TO PHARMACOLOGY 2019/20: Ion channels. Br J Pharmacol. 2019;176(Suppl 1):S142-S228. https://doi.org/10.1111/bph.14749
Victorri-Vigneau C, Basset G, Bourin M, Jolliet P. Impacts of the new flunitrazepam regulations on the consumption of hypnotics. Therapie. 2003;58(5):425-430. https://doi.org/10.2515/therapie:2003069
Rousselet M, Feuillet F, Gerardin M, Jolliet P, Hardouin J-B, Victorri-Vigneau C. The French addictovigilance network clinical assessment: Z-drugs, true false twins. Expert Opin Drug Saf. 2017;16(9):1063- 1069. https://doi.org/10.1080/14740338.2017.1346084
Faccini M, Leone R, Pajusco B, et al. Lormetazepam addiction: data analysis from an Italian medical unit for addiction. Risk Manag Healthc Policy. 2012;5:43-48. https://doi.org/10.2147/RMHP.S31745
Cimolai N. Zopiclone: is it a pharmacologic agent for abuse? Can Fam Physician Med Fam Can. 2007;53(12):2124-2129.
Frauger E, Nordmann S, Orleans V, et al. Which psychoactive prescription drugs are illegally obtained and through which ways of acquisition? About OPPIDUM survey: Which psychoactive prescription drugs are illegally obtained? Fundam Clin Pharmacol. 2012;26(4):549-556. https://doi.org/10.1111/j.1472-8206.2011.00950.x
Haute Autorité de Santé (HAS). Commission de la transparence - Avis du 25 juin 2014. Accessed January 7, 2021. https://www.has-sante.fr/upload/docs/application/pdf/2014-07/stilnox_reeval_ri_avis1_ct11444_ct13218.pdf
The Food & Drug Administration. Published online 2020. Accessed January 7, 2021. https://www.fda.gov/
The French Addictovigilance Network. Published online 2020. Accessed January 7, 2021. https://www.ansm.sante.fr/Declarer-un-effet-indesirable/Pharmacodependance-Addictovigilance/Pharmacodependance-Addictovigilance/(offset)/0
Takeshima N, Ogawa Y, Hayasaka Y, Furukawa TA. Continuation and discontinuation of benzodiazepine prescriptions: A cohort study based on a large claims database in Japan. Psychiatry Res. 2016;237:201-207. https://doi.org/10.1016/j.psychres.2016.01.040
Guerlais M, Grall-Bronnec M, Feuillet F, Gérardin M, Jolliet P, Victorri-Vigneau C. Dependence on prescription benzodiazepines and Z-drugs among young to middle-aged patients in France. Subst Use Misuse. 2015;50(3):320-327. https://doi.org/10.3109/10826084.2014.980952
Panes A, Pariente A, Bénard-Laribière A, et al. Use of benzodiazepines and z-drugs not compliant with guidelines and associated factors: a population-based study. Eur Arch Psychiatry Clin Neurosci. 2020;270(1):3-10. https://doi.org/10.1007/s00406-018-0966-3
Victorri-Vigneau C, Laforgue E-J, Grall-Bronnec M, et al. Are seniors dependent on benzodiazepines? A national clinical survey of substance use disorder. Clin Pharmacol Ther. 2020;109(2):528-535. https://doi.org/10.1002/cpt.2025
Sjöstedt C, Ohlsson H, Li X, Sundquist K. Socio-demographic factors and long-term use of benzodiazepines in patients with depression, anxiety or insomnia. Psychiatry Res. 2017;249:221-225. https://doi.org/10.1016/j.psychres.2017.01.046
Kurko TAT, Saastamoinen LK, Tähkäpää S, et al. Long-term use of benzodiazepines: Definitions, prevalence and usage patterns - a systematic review of register-based studies. Eur Psychiatry J Assoc Eur Psychiatr. 2015;30(8):1037-1047. https://doi.org/10.1016/j.eurpsy.2015.09.003
Hajak G, Müller WE, Wittchen HU, Pittrow D, Kirch W. Abuse and dependence potential for the non-benzodiazepine hypnotics zolpidem and zopiclone: a review of case reports and epidemiological data. Addict Abingdon Engl. 2003;98(10):1371-1378. https://doi.org/10.1046/j.1360-0443.2003.00491.x
Greenblatt DJ, Harmatz JS, Roth T. Zolpidem and gender: Are women really at risk? J Clin Psychopharmacol. 2019;39(3):189-199. https://doi.org/10.1097/JCP.0000000000001026
Cubała WJ, Wiglusz M, Burkiewicz A, Gałuszko-Węgielnik M. Zolpidem pharmacokinetics and pharmacodynamics in metabolic interactions involving CYP3A: sex as a differentiating factor. Eur J Clin Pharmacol. 2010;66(9):955. https://doi.org/10.1007/s00228-010-0854-x