Responsiveness of Veterans Affairs Health Care System to Zolpidem Safety Warnings

Kim, Hyungjin Myra; Gerlach, Lauren B.; Yosef, Matheos; Stano, Claire; Conroy, Deirdre A.; Valenstein, Marcia; Pfeiffer, P.; Sales, Anne E.; Zivin, Kara

doi:10.5664/jcsm.7210

Cited by 3 publications

(2 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Considering that there was no change in the proportion of patients using other hypnotics with similar pharmacological effects as zolpidem, the trend changes in zolpidem use in the month of broadcast could be explained by the effect of broadcasting on zolpidem safety. The change in medication use according to the spread of medication safety information is well known [ 15 , 33 , 34 ]. However, the sources of information include label change or DSC led by an authorization body such as the FDA; thus, the matter of obtaining safety information was mainly through HCPs.…”

Section: Discussionmentioning

confidence: 99%

Interrupted Time Series Analysis of Changes in Zolpidem Use Due to Media Broadcasts

Yang

Heo

et al. 2021

IJERPH

View full text Add to dashboard Cite

Media has become a major source of information on health and plays a role in the decision-making process on health topics. We aimed to evaluate the association between zolpidem use and media broadcasts that reported the suicide risk. We obtained the data of adult outpatients who have been prescribed zolpidem or other hypnotics from the National Patient Sample database (2015–2017). We evaluated the change in zolpidem or other hypnotic prescription trends based on the prescription rate and average daily prescribed dose before and after July 2016, using interrupted time series analysis. A total of 129,787 adult patients had at least one zolpidem prescription in 3 years. The prescription rate of zolpidem after the broadcast decreased significantly by 0.178% (95% confidence interval (CI): −0.214, −0.142), whereas that of other hypnotic users did not differ from that before the broadcast (−0.020%, 95% CI: −0.088, 0.047). However, the trends in the prescription rate before and after the broadcast did not differ for zolpidem and other hypnotics. Broadcasting medication safety through major public media could have an effect on medication use. After broadcasting about the suicide risk of zolpidem, its overall prescription rate decreased immediately, but the trend was not changed.

show abstract

Section: Discussionmentioning

confidence: 99%

Interrupted Time Series Analysis of Changes in Zolpidem Use Due to Media Broadcasts

Yang

Heo

et al. 2021

IJERPH

View full text Add to dashboard Cite

show abstract

“…In this issue of the Journal of Clinical Sleep Medicine, Kim and colleagues present findings on prescriptions in the VHA following the zolpidem safety warnings. 16 Using an interrupted time-series design the authors examined monthly outpatient use of (1) higher-than-recommended dose of zolpidem among zolpidem users and (2) any dose zolpidem among all VHA users. Sensitivity analyses compared prescribing of zolpidem to other sleep medications not subject to safety warnings.…”

Section: Patterns Of Zolpidem Use In Male and Female Veterans Following Revised Fda Dosing Guidelinesmentioning

confidence: 99%

Patterns of Zolpidem Use in Male and Female Veterans Following Revised FDA Dosing Guidelines

Inslicht

Neylan

2018

Journal of Clinical Sleep Medicine

View full text Add to dashboard Cite

Zolpidem and Gender: Are Women Really At Risk?

Greenblatt

Harmatz

Roth

2019

J Clin Psychopharmacol

View full text Add to dashboard Cite

Background In 2013 the Food and Drug Administration (FDA) claimed the existence of new data showing women to be at risk for excessive daytime sedation and impaired driving proficiency following bedtime doses of zolpidem. The putative explanation was the reduced metabolic clearance of zolpidem and higher morning blood concentrations in women compared to men. The FDA acted to reduce the recommended dosage for women down to 50% of the dose for men. No other regulatory agency worldwide has taken similar action. Methods Gender effects on zolpidem pharmacokinetics, pharmacodynamics, adverse effects, clinical efficacy, and driving performance were evaluated through a further analysis of data from a previous study, together with a literature review. Results Women had on average 35% lower apparent clearance of zolpidem than men (236 vs 364 mL/min, P < 0.001). This difference was not explained by body weight. In some laboratory studies, women had greater functional impairment than men taking the same dose, but in all studies active drug was not distinguishable from placebo at 8 hours after oral dosage. On-the-road driving studies likewise showed no evidence of driving impairment in men or women at 8 hours after 10 mg of oral immediate-release zolpidem. No clinical trial demonstrated a gender-related difference in clinical efficacy or adverse reactions, and there was no evidence of a particular risk to women. Conclusions Dosage reduction in women is not supported by available scientific evidence, and may in fact lead to underdosing and the consequent hazard of inadequately treated insomnia.

show abstract

Responsiveness of Veterans Affairs Health Care System to Zolpidem Safety Warnings

Abstract: A commentary on this article appears in this issue on page 1093.

Cited by 3 publications

References 24 publications

Interrupted Time Series Analysis of Changes in Zolpidem Use Due to Media Broadcasts

Interrupted Time Series Analysis of Changes in Zolpidem Use Due to Media Broadcasts

Patterns of Zolpidem Use in Male and Female Veterans Following Revised FDA Dosing Guidelines

Zolpidem and Gender: Are Women Really At Risk?

Contact Info

Product

Resources

About