ArticleJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2017
Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003-2012.
Article in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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Who cites it
23 citing papers in PubMed.
- Armodafinil to reduce the sleepiness related side-effects of sleep restriction therapy being used to treat insomnia disorder: An open label clinical trial pilot study compared with historical controls.Journal of sleep research · 2023Trial
- Zopiclone-associated hallucinations: a case report and database pharmacovigilance study.Frontiers in psychiatry · 2026Article
- Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety.Drug safety · 2025Article
- Gender differences in spontaneous adverse event reports associated with zolpidem in South Korea, 2015-2019.Frontiers in pharmacology · 2023Article
- Case report: Hyperactive delirium after a single dose of zolpidem administered additionally to psychopharmacotherapy including clozapine.Frontiers in psychiatry · 2023Article
- Pharmacotherapeutic management of insomnia and effects on sleep processes, neural plasticity, and brain systems modulating stress: A narrative review.Frontiers in neuroscience · 2022Review
- Analysis of Medical Services for Insomnia in Korea: A Retrospective, Cross-Sectional Study Using the Health Insurance Review and Assessment Claims Data.Healthcare (Basel, Switzerland) · 2021Article
- Zolpidem for Insomnia: A Double-Edged Sword. A Systematic Literature Review on Zolpidem-Induced Complex Sleep Behaviors.Indian journal of psychological medicine · 2021Article
- Prescription medications for insomnia are associated with suicidal thoughts and behaviors in two nationally representative samples.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021Article
- Change Point Analysis for Detecting Vaccine Safety Signals.Vaccines · 2021Article
- Zolpidem: Efficacy and Side Effects for Insomnia.Health psychology research · 2021Review
- Korean Clinical Practice Guideline for the Diagnosis and Treatment of Insomnia in Adults.Psychiatry investigation · 2020Article
- US Food and Drug Administration Safety Advisories and Reporting to the Adverse Event Reporting System (FAERS).Pharmaceutical medicine · 2020Article
- Temporal association between zolpidem medication and the risk of suicide: A 12-year population-based, retrospective cohort study.Scientific reports · 2020Article
- Concurrent use of benzodiazepines, antidepressants, and opioid analgesics with zolpidem and risk for suicide: a case-control and case-crossover study.Social psychiatry and psychiatric epidemiology · 2019Article
- Adverse Drug Reaction Risk Measures: A Comparison of Estimates from Drug Surveillance and Randomised Trials.Pharmaceutical medicine · 2019Article
- Visual Hallucinations from Zolpidem Use for the Treatment of Hospital Insomnia in a Septuagenarian.Cureus · 2019Article
- Single-use suvorexant for treating insomnia during overnight polysomnography in patients with suspected obstructive sleep apnea: a single-center experience.Drug design, development and therapy · 2019Observational
- Use of Sedative-Hypnotics and Mortality: A Population-Based Retrospective Cohort Study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2018Article
- Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesStimulated reporting occurs when patients and healthcare professionals are influenced or "stimulated" by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006-2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored.
methodsUsing disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012.
resultsOdds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster.
conclusionsAlthough our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies.
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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.