Z-drugs carry a boxed warning for things people do while not fully awake
The FDA added a boxed warning in 2019 after injuries and deaths from sleepwalking and sleep-driving.
Top of the evidence hierarchy, independently funded. how we score evidence
In April 2019 the FDA added a boxed warning to zolpidem, eszopiclone and zaleplon — the medications sold as Ambien, Lunesta and Sonata. The reason was complex sleep behaviours: sleepwalking, sleep-driving, and doing other things while not fully awake, which have caused serious injuries and deaths. These events are rare, and they have happened to people at normal doses on their first night.
The FDA also made it a contraindication. If you have ever had one of these episodes on any of these three drugs, none of them should be prescribed to you again.
Worth asking
Have I ever done anything while asleep that I could not remember, is there a non-drug option we have not tried for my sleep, and what is the plan for coming off this given how quickly tolerance builds.
Source
Certain Prescription Insomnia Medicines: New Boxed Warning Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake — U.S. 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
- Yes
- Independent of proponent
- Yes
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 5, 2026. Last verified August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "gold standard". Top of the evidence hierarchy, independently funded. It scores 86 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?
Certain Prescription Insomnia Medicines: New Boxed Warning Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake — U.S. 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 z_drug FDA approved?
Yes — this medication carries FDA approval. Approval is always for a specific indication, not for every use it 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.