Adverse Events Due to Insomnia Drugs Reported in a Regulatory Database and Online Patient Reviews: Comparative Study

Patient 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. We 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. Patient 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. Similar 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. 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.