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FDA zolpidem Drug Safety Communications (2013)

Also: Zolpidem lower dose for women · next-morning impairment warning

FDA safety communications and label changes recommending a lower starting dose of zolpidem (5 mg immediate release for women) because of next-morning impairment and drowsy driving.

Years
2013
Country
United States
Topic
Patient safetySleep
Asks people to
Stop
Strategy
Warning label
Channel
Clinical settingWebsite
Audience
AdultsClinicians
Prescribers, pharmacists, patients

Evidence

Quasi-experimentalPositive

National ITS: high-dose zolpidem users fell by 12.5 per 10,000 population right after the warnings and 59% by study end; poison-center exposures also fell. In the VA, high-dose use (already cut from about 10% to 2% by a 2007 VA warning) fell again but about half of women veterans stayed on high doses; sedating antidepressant use rose. Pharmacy and health-system studies show dose compliance rose but stayed low (16% compliant in one chain).

Sponsor (who paid)

  • US Food and Drug Administration Federal government

Credits (who made it)

Not recorded yet.

Sources

  1. Trend changes of national zolpidem users and exposure cases after FDA drug safety communications evaluation · 2021 · DOI 10.1002/pds.5344 · PMID 34382718
  2. Responsiveness of Veterans Affairs Health Care System to Zolpidem Safety Warnings evaluation · 2018 · DOI 10.5664/jcsm.7210 · PMID 29991420
  3. Zolpidem prescribing practices before and after FDA required product labeling changes evaluation · 2017 · DOI 10.1177/2050312117707687 · PMID 28515934
  4. Impact of a US FDA Drug Safety Communication on Zolpidem Dosing evaluation · 2015 · DOI 10.4088/PCC.14m01728 · PMID 26644946
  5. Methodological approaches to evaluate the impact of FDA drug safety communications reference · 2015 · DOI 10.1007/s40264-015-0291-y · PMID 25968811

Research notes

Created 2026-10-23 from the sleep campaign literature search (PubMed and web search; OpenAlex was unreachable), see docs/sleep-campaigns-literature.md. Findings are paraphrased from abstracts, not full texts; official URLs come from search results and were not opened. Reuse terms checked 2026-10-23 by an AI research pass for #47; not yet reviewed by a person.

Record cases/fda-zolpidem-safety-communication-2013.json, updated 2026-10-23· Link to this campaign