Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 15, 2019
Open Peer Review Period: Jan 18, 2019 - Mar 15, 2019
Date Accepted: Sep 26, 2019
(closed for review but you can still tweet)
A comparison of adverse events associated with insomnia drugs in patient online reviews and the FAERS database
ABSTRACT
Background:
Patient online drug reviews are a resource for other patients seeking information about the practical benefits of drug therapies. Patient reviews may also serve as a source of post marketing safety data that is more user-friendly than regulatory databases. Hypnotic medications are particularly well-suited to direct evaluation by patients, because they are commonly used, and their acceptability of treatment provides insight into the balance of efficacy and adverse effects.
Objective:
Our primary objective was to compare adverse event data in the FDA Adverse Event Reporting System (FAERS) with analogous information in customer reviews of hypnotic medications on the consumer health website Drugs.com. Secondary objectives were to describe patient reports of efficacy and adverse effects, and to determine whether cost, effectiveness, or adverse effects impacted the user’s rating of hypnotic medications.
Methods:
Patient ratings and narratives were retrieved from 1407 reviews on Drugs.com between February 2007 and March 2018 for the hypnotics eszopiclone, ramelteon, suvorexant, zaleplon, and zolpidem. Reviews were coded to preferred terms in the Medical Dictionary for Regulatory Activities. Data were compared to 5916 cases in the FAERS database from January 2015 to September 2017.
Results:
Drugs.com and FAERS identified many of the same adverse events as the most frequent. In both resources, lack of efficacy was a common complaint for all five drugs. Amnesia was common with eszopiclone, zaleplon, and zolpidem. Zolpidem users experienced a high rate of partial sleep activities, while suvorexant users complained of parasomnias. Based on patient rankings, zolpidem was the highest rated hypnotic. Statistical analyses showed that patient ranking is influenced by considerations of efficacy and adverse effects, while drug cost is unimportant.
Conclusions:
For 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.
Citation
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Copyright
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