ArticleJournal of medical Internet research2019
Adverse Events Due to Insomnia Drugs Reported in a Regulatory Database and Online Patient Reviews: Comparative Study.
Article in Journal of medical Internet research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Self-Reported Adverse Events in Psychiatric Outpatients Taking Hypnotics: Higher Real-World Frequencies Than Those Listed in Package Inserts.Neuropsychopharmacology reports · 2026Article
- Zopiclone-associated hallucinations: a case report and database pharmacovigilance study.Frontiers in psychiatry · 2026Article
- Targeting the Orexin System in the Pharmacological Management of Insomnia and Other Diseases: Suvorexant, Lemborexant, Daridorexant, and Novel Experimental Agents.International journal of molecular sciences · 2025Review
- Early small bowel obstruction by phytobezoar related to zopiclone induced amnesia after revisional Roux-en-Y gastric bypass: a case report.Journal of surgical case reports · 2025Article
- Exploring the Effects and Mechanisms of Valerian Volatile Oil in Treating Insomnia Using Network Pharmacology, Molecular Docking, and Molecular Dynamics Simulation-Based Approaches.International journal of molecular sciences · 2025Article
- The Value of Social Media Analysis for Adverse Events Detection and Pharmacovigilance: Scoping Review.JMIR public health and surveillance · 2024Article
- Is there a better way to wean chronic benzodiazepine receptor agonists use by substituting a DORA (and starting CBT-I)?Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024Article
- The Function of Sleep and the Treatment of Primary Insomnia.Deutsches Arzteblatt international · 2023Review
- Efficacy and safety of pharmacotherapy in chronic insomnia: A review of clinical guidelines and case reports.The mental health clinician · 2023Review
- Article
- Patient reporting of sexual adverse events on an online platform for medication experiences.British journal of clinical pharmacology · 2022Article
- Exploration of Ziziphi Spinosae Semen in Treating Insomnia Based on Network Pharmacology Strategy.Evidence-based complementary and alternative medicine : eCAM · 2021Article
- Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatient online drug reviews are a resource for other patients seeking information about the practical benefits and drawbacks of drug therapies. Patient reviews may also serve as a source of postmarketing safety data that are more user-friendly than regulatory databases. However, the reliability of online reviews has been questioned, because they do not undergo professional review and lack means of verification.
objectiveWe evaluated online reviews of hypnotic medications, because they are commonly used and their therapeutic efficacy is particularly amenable to patient self-evaluation. Our primary objective was to compare the types and frequencies of adverse events reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) with analogous information in patient reviews on the consumer health website Drugs.com. The secondary objectives were to describe patient reports of efficacy and adverse events and assess the influence of medication cost, effectiveness, and adverse events on user ratings of hypnotic medications.
methodsPatient ratings and narratives were retrieved from 1407 reviews on Drugs.com between February 2007 and March 2018 for eszopiclone, ramelteon, suvorexant, zaleplon, and zolpidem. Reviews were coded to preferred terms in the Medical Dictionary for Regulatory Activities. These reviews were compared to 5916 cases in the FAERS database from January 2015 to September 2017.
resultsSimilar adverse events were reported to both Drugs.com and FAERS. Both resources identified a lack of efficacy as a common complaint for all five drugs. Both resources revealed that amnesia commonly occurs with eszopiclone, zaleplon, and zolpidem, while nightmares commonly occur with suvorexant. Compared to FAERS, online reviews of zolpidem reported a much higher frequency of amnesia and partial sleep activities. User ratings were highest for zolpidem and lowest for suvorexant. Statistical analyses showed that patient ratings are influenced by considerations of efficacy and adverse events, while drug cost is unimportant.
conclusionsFor hypnotic medications, online patient reviews and FAERS emphasized similar adverse events. Online reviewers rated drugs based on perception of efficacy and adverse events. We conclude that online patient reviews of hypnotics are a valid source that can supplement traditional adverse event reporting systems.
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