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

Jessica L Norman; Danielle R Fixen; Joseph J Saseen; Laura M Saba; Sunny A Linnebur

doi:10.1177/2050312117707687

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

SAGE Open Med. 2017 May 5:5:2050312117707687. doi: 10.1177/2050312117707687. eCollection 2017.

Authors

Jessica L Norman¹, Danielle R Fixen², Joseph J Saseen^{2

3}, Laura M Saba⁴, Sunny A Linnebur²

Affiliations

¹ University of Wisconsin Hospital and Clinics, Madison, WI, USA.
² Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
³ Department of Family Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁴ Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

Abstract

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 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' records was also evaluated.

Results: A total of 400 patients were included in the study. The overall percentage of patients prescribed low-dose zolpidem increased from 44% to 58% after the labeling change (p = 0.0020). In a pre-specified subgroup analysis, the percentage of patients prescribed low-dose zolpidem increased in all groups, including young men (38%-50%, p = 0.23), elderly men (34%-40%, p = 0.53), and elderly women (60%-74%, p = 0.14), but the change was only significant in young women (42%-70%, p = 0.0045).

Conclusion: After Food and Drug Administration-mandated labeling changes for zolpidem in 2013, the percentage of overall patients in our health system, and specifically young women, with initial prescriptions for low-dose zolpidem significantly increased as compared to before the labeling change.

Keywords: United States Food and Drug Administration; Zolpidem; drug safety; insomnia; sleep initiation and maintenance disorders.