Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes

SAGE Open Medicine
Jessica L NormanSunny A Linnebur

Abstract

Women have higher morning serum zolpidem concentrations than men after taking an evening dose, potentially leading to increased risk of harm. On 19 April 2013, the United States Food and Drug Administration required labeling changes for zolpidem, recommending an initial dose of no greater than 5 mg (immediate release) or 6.25 mg (controlled release) per night in women. The primary objective of this study was to compare prescribing practices before and after the 2013 zolpidem labeling change. A secondary objective was to evaluate serious adverse events potentially related to zolpidem. Electronic medical records of adults receiving care through the University of Colorado Health system were accessed for study inclusion if patients were provided a first-time prescription for zolpidem either prior to or after the Food and Drug Administration labeling change. Patients were randomly chosen from eight strata based on age, gender, and date of zolpidem initiation (before/after the labeling change). Demographic and zolpidem prescribing data were collected. Low-dose zolpidem was considered 5 mg (immediate release) or 6.25 mg (controlled release) daily or less. Documentation of potentially related serious adverse events within the patients'...Continue Reading

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Citations

Apr 3, 2019·Journal of Clinical Psychopharmacology·David J GreenblattThomas Roth
Feb 12, 2020·Pharmacoepidemiology and Drug Safety·Ulrike GeorgiStefanie Deckert
Sep 24, 2020·Pharmacoepidemiology and Drug Safety·James B LeonardWendy Klein-Schwartz
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May 12, 2018·Journal of Analytical Toxicology·Sheng FengGregory McIntire
Jun 13, 2020·NPJ Digital Medicine·Davide CirilloNikolaos Mavridis
Feb 29, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Cordula StillhartAnette Müllertz
Feb 19, 2021·NPJ Digital Medicine·Davide CirilloNikolaos Mavridis
Mar 24, 2021·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Zahari VinarovPatrick Augustijns
May 21, 2021·Advanced Drug Delivery Reviews·Christine M MadlaAbdul W Basit
Jun 3, 2021·International Journal of Environmental Research and Public Health·Bo-Ram YangYoung-Mi Ah
Aug 28, 2021·Revista colombiana de psiquiatría·Gonzalo Emmanuel Barbosa Eyler, Jhoan Vidal Utria Castro

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