FDA Boxed Warning on complex sleep behaviors with Z-drugs (2019)
On 30 April 2019 FDA added a Boxed Warning and a contraindication to eszopiclone, zaleplon and zolpidem after reviewing 66 cases of sleepwalking, sleep-driving and other complex sleep behaviours causing serious injury or death, and told patients who experience them to stop the drug.
- Years
- 2019
- Country
- United States
- Topic
- Patient safetySleep
- Asks people to
- Stop
- Strategy
- Warning label
- Channel
- Clinical settingPackaging
- Audience
- AdultsCliniciansPrescribers, patients
Evidence
NoneUnknown
No PubMed study of the 2019 warning's effect on prescribing was found. US benzodiazepine-receptor agonist prescribing had already been falling since a 2014 peak (to about half by 2023) while trazodone rose.
Sponsor (who paid)
- US Food and Drug Administration Federal government
Credits (who made it)
Not recorded yet.
Sources
- FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines sponsor · 2019
- Association of eszopiclone, zaleplon, or zolpidem with complex sleep behaviors resulting in serious injuries, including death reference · 2020 · DOI 10.1002/pds.5004 · PMID 32323442
- Time Trends in Prescribing of Anxiolytic, Sedative, and Hypnotic Drugs in the United States reference · 2026 · DOI 10.1016/j.clinthera.2025.12.014 · PMID 41571518
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. Gap: an ITS of the 2019 warning would be a useful study. Reuse terms checked 2026-10-23 by an AI research pass for #47; not yet reviewed by a person.
Record cases/fda-z-drug-boxed-warning-2019.json, updated 2026-10-23· Link to this campaign