ArticleThe international journal of neuropsychopharmacology2019
An Insight into Z-Drug Abuse and Dependence: An Examination of Reports to the European Medicines Agency Database of Suspected Adverse Drug Reactions.
Article in The international journal of neuropsychopharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 7 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
81 citing papers in PubMed, 7 syntheses or guidelines pooled it, 180 citations in OpenAlex.
- Evidence-based consensus guidelines for the pharmacological management of substance dependence: Recommendations from the British Association for Psychopharmacology.Journal of psychopharmacology (Oxford, England) · 2026Guideline
- Z-drug abuse and dependence: clinical guideline of the Brazilian Academy of Neurology for diagnosis and management.Arquivos de neuro-psiquiatria · 2025Guideline
- Commercial Chinese polyherbal preparation Zao Ren An Shen prescription for primary insomnia: a systematic review with meta-analysis and trial sequential analysis.Frontiers in pharmacology · 2024Pooled it
- The safety and efficacy of gabapentinoids in the management of neuropathic pain: a systematic review with meta-analysis of randomised controlled trials.International journal of clinical pharmacy · 2023Pooled it
- Identifying complementary and alternative medicine recommendations for insomnia treatment and care: a systematic review and critical assessment of comprehensive clinical practice guidelines.Frontiers in public health · 2023Pooled it
- Traditional East Asian Herbal Medicine for Post-Stroke Insomnia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.International journal of environmental research and public health · 2022Pooled it
- Pooled it
- Patient experiences of benzodiazepine tapering: a qualitative study of treatment in addiction care.BMC psychiatry · 2026Article
- Investigating Bidirectional Causal Relationships Between Imaging-Derived Brain Phenotypes and Sedative-Hypnotic Use Disorder: A Mendelian Randomization Study.Addiction biology · 2026Article
- Two Case Reports of Zolpidem Abuse and a Contemporary Review.Journal of psychiatric practice · 2026Review
- Sleep psychoeducation strategies for patients with chronic migraine and sleep quality complaints.Arquivos de neuro-psiquiatria · 2026Article
- Evaluating and Determining the Effects of Psychotropic Drugs on Motor Vehicle Driving Performance: Key Considerations of the Japanese Guideline and Criteria for Clinical Implementation of Evidence.Neuropsychopharmacology reports · 2026Review
- Analysis of the correlation between the degree of sleepiness and the therapeutic effect in patients with insomnia disorder treated with digital cognitive behavioral therapy.Frontiers in psychiatry · 2026Article
- Self-reported sleep variables, sleep quality, and quality of life assessment in transition to lemborexant in patients with Insomnia: the multicenter, open-label SOMNUS study.Sleep medicine: X · 2025Article
- Dreaming of Better Treatments: Advances in Drug Development for Sleep Medicine and Chronotherapy.Journal of sleep research · 2025Review
- Prescribing controlled substances in sleep medicine clinics: an overview of legal issues and best safety practices.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025Review
- The Efficacy of Melatonergic Receptor Agonists Used in Clinical Practice in Insomnia Treatment: Melatonin, Tasimelteon, Ramelteon, Agomelatine, and Selected Herbs.Molecules (Basel, Switzerland) · 2025Review
- Encouraging General Practitioners to Refer Patients With Insomnia to a Digital Therapeutic (Sleepio): Feasibility Repeated-Measures Intervention Study.JMIR formative research · 2025Article
- Association between energy-adjusted dietary inflammatory index and sleep quality disorders: a cross-sectional study on fasa adult cohort.Journal of health, population, and nutrition · 2025Article
- Expert Consensus on the Use of Diphenhydramine for Short-Term Insomnia: Efficacy, Safety, and Clinical Applications.Journal of clinical medicine · 2025Review
21 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough 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.
methodsAnalyzing the adverse drug reactions databases of each Z-drug, descriptive analyses have been performed on cases and proportional reporting ratios (PRRs) computed.
resultsAn 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.
conclusionCurrent 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.