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

SAGE Open Medicine

Jessica LNorman¹ 

关键词: Zolpidem;    insomnia;    sleep initiation;    maintenance disorders;    United States Food;    Drug Administration;    drug safety;   

DOI  :  10.1177/2050312117707687

学科分类：医学（综合）

来源: Sage Journals

【 摘 要 】

Background: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.Objectives: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.Methods: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 labeli...

【 授权许可】

CC BY