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dc.contributor.authorSchifano, Fabrizio
dc.contributor.authorChiappini, Stefania
dc.contributor.authorCorkery, John Martin
dc.contributor.authorGuirguis, Amira
dc.date.accessioned2019-02-07T12:00:08Z
dc.date.available2019-02-07T12:00:08Z
dc.date.issued2019-04-01
dc.identifier.citationSchifano , F , Chiappini , S , Corkery , J M & Guirguis , A 2019 , ' An Insight into Z-Drug Abuse and Dependence : An Examination of Reports to the European Medicines Agency Database of Suspected Adverse Drug Reactions ' , International Journal of Neuropsychopharmacology , vol. 22 , no. 4 , pp. 270-277 . https://doi.org/10.1093/ijnp/pyz007
dc.identifier.issn1461-1457
dc.identifier.otherPURE: 16216167
dc.identifier.otherPURE UUID: 7f9b884c-61bf-430b-b36a-b962687506bf
dc.identifier.otherScopus: 85063961235
dc.identifier.urihttp://hdl.handle.net/2299/21044
dc.description© The Author(s) 2019. Published by Oxford University Press on behalf of CINP.
dc.description.abstractBACKGROUND: Although originally marketed as safe alternatives to the habit-forming benzodiazepines, growing numbers of zaleplon, zolpidem, and zopiclone ("Z-drugs") clinical concerns relating to their potential of abuse, dependence, and withdrawal have been reported over time. We aimed here at assessing these issues analyzing datasets of adverse drug reactions provided by the European Medicines Agency through the EudraVigilance system. METHODS: Analyzing the adverse drug reactions databases of each Z-drug, descriptive analyses have been performed on cases and proportional reporting ratios (PRRs) computed. RESULTS: An overall number of 33 240 (e.g., 23 420 zolpidem; 9283 zopiclone; and 537 zaleplon) misuse-, abuse-, dependence-, and withdrawal-related adverse drug reactions, corresponding to some 6246 unique patients given Z-drugs, were here identified. Cases were studied and described, including demographic characteristics and clinical data such as concomitant drugs, doses, routes of administration, and outcomes of the reactions (being fatalities recorded). Considering PRR values and in comparison with zopiclone, zolpidem was more frequently involved in both misuse/abuse and withdrawal issues. Zolpidem and zopiclone presented with the same dependence risk, but zopiclone was most involved in overdose adverse drug reactions. Compared with zaleplon, zopiclone presented higher dependence and overdose-related issues but slightly lower misuse/abuse and withdrawal PRR values. CONCLUSION: Current data may only represent a gross underestimate of the real prevalence of Z-drug misuse. Caution should be exercised when prescribing those molecules, especially for patients with psychiatric illnesses and/or history of drug abuse. We recommend the need to invest in proactive pharmacovigilance activities to better and promptly detect, understand, and prevent any possible misuse potential of prescribed medications.en
dc.format.extent8
dc.language.isoeng
dc.relation.ispartofInternational Journal of Neuropsychopharmacology
dc.rightsOpen
dc.subjectadverse drug reactions
dc.subjectEMA
dc.subjectZ-drugs
dc.subjectzaleplon
dc.subjectzolpidem
dc.subjectzopiclone
dc.subjectPharmacology
dc.subjectPsychiatry and Mental health
dc.subjectPharmacology (medical)
dc.titleAn Insight into Z-Drug Abuse and Dependence : An Examination of Reports to the European Medicines Agency Database of Suspected Adverse Drug Reactionsen
dc.contributor.institutionCentre for Clinical Practice, Safe Medicines and Drug Misuse Research
dc.contributor.institutionPsychopharmacology, Drug Misuse and Novel Psychoactive Substances Unit
dc.contributor.institutionCentre for Health Services and Clinical Research
dc.contributor.institutionSchool of Life and Medical Sciences
dc.contributor.institutionDepartment of Clinical and Pharmaceutical Sciences
dc.description.statusPeer reviewed
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85063961235&partnerID=8YFLogxK
dc.relation.schoolSchool of Life and Medical Sciences
dc.description.versiontypeFinal Accepted Version
dcterms.dateAccepted2019-04-01
rioxxterms.versionAM
rioxxterms.versionAM
rioxxterms.versionofrecordhttps://doi.org/10.1093/ijnp/pyz007
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by-nc/4.0/
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue
herts.rights.accesstypeOpen


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