Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003-2012.

ABSTRACT:

Study objectives

Stimulated 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.

Methods

Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomni

SUBMITTER: Wong CK 

PROVIDER: S-EPMC5263078 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature