Trend changes of national zolpidem users and exposure cases after FDA drug safety communications

Author:

Zhou Esther H.1ORCID,Feng Zhou1ORCID,Pinnow Ellen1ORCID,Lee Joann1,Bak Daniel1,Ready Travis1,Dal Pan Gerald J.1ORCID

Affiliation:

1. Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference27 articles.

1. Guidance: Drug Safety Information – FDA's Communication to the Public.https://www.fda.gov/media/83097/download. Accessed July 31 2021.

2. Previous Drug Safety Communications:https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications. Accessed July 31 2021.

3. US Department of Health and Human Services Food and Drug Administration.FDA Drug Safety Communication: Risk of Next‐morning Impairment After use of Insomnia Drugs; FDA Requires Lower Recommended Doses for Certain Drugs Containing Zolpidem (Ambien Ambien CR Edluar and Zolpimist).2013.https://www.fda.gov/media/84992/download. Accessed July 31 2021.

4. US Department of Health and Human Services Food and Drug Administration.FDA Drug Safety Communication: FDA Approves New Label Changes and Dosing for Zolpidem Products and a Recommendation to Avoid Driving the Day After Using Ambien CR.2013.https://www.fda.gov/Drugs/DrugSafety/ucm352085.htm. Accessed July 31 2021.

5. Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem

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