FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia…
If I ever sleepwalk, drive, or do anything I don't remember after taking zolpidem, should I stop it immediately and call you before the next dose?
Well-supported by good-quality research. how we score evidence
In April 2019 the FDA added its most serious (boxed) warning to zolpidem and other z-drugs after reports of sleepwalking, sleep-driving and other complex sleep behaviors causing serious injuries and deaths, and made the drugs contraindicated for anyone who has ever had such an episode on them.
Worth asking
If I ever sleepwalk, drive, or do anything I don't remember after taking zolpidem, should I stop it immediately and call you before the next dose?
What it is FDA approved for
Read off the label. Trial duration and approval year are shown only where they were recorded — never inferred.
- Short-term treatment of insomnia characterized by difficulties with sleep initiation
Source
FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines (zolpidem, eszopiclone, zaleplon) — US Food and Drug Administration (2019)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- No external funding
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- No
- Conflicts disclosed
- No
- Independent of proponent
- Yes
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "strong evidence". Well-supported by good-quality research. It scores 82 out of 100 on our published rubric. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines (zolpidem, eszopiclone, zaleplon) — US Food and Drug Administration (2019). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: No external funding. The researchers were independent of whoever benefits from the result. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is zolpidem (Ambien, Edluar, Intermezzo), ambien, edluar, intermezzo FDA approved?
Yes — FDA approved for Short-term treatment of insomnia characterized by difficulties with sleep initiation. Approval is for a specific indication, not for everything the drug is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.