The temazepam label: approved for 7 to 10 days of insomnia, with the boxed warning every benzodiazepine carries
Restoril is approved for short-term insomnia, "generally 7 to 10 days", and its efficacy trials ran 2 weeks. The boxed warning covers opioids, misuse and addiction, and dependence with withdrawal that can be life-threatening.
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: Approved for 7 to 10 days; the label gives directions of risk without frequencies for that use.
The FDA-approved label for temazepam (Restoril), read for how long it was tested and what it warns about.
Significant findings
RESTORIL "is indicated for the short-term treatment of insomnia (generally 7 to 10 days)", and the label adds: "The clinical trials performed in support of efficacy were 2 weeks in duration". The usual adult dose is 15 mg at bedtime, with 7.5 mg suggested for elderly or debilitated patients.
The boxed warning, shared by every benzodiazepine since 2020: "Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death." Use "exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death." And "The continued use of benzodiazepines, including Restoril, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of Restoril after continued use may precipitate acute withdrawal reactions, which can be life-threatening." The label tells prescribers to use a gradual, patient-specific taper and, if withdrawal appears, to consider pausing the taper or returning to the previous step.
The warnings section describes complex sleep behaviours such as "sleep-driving" with amnesia for the event, more likely with alcohol or above the maximum dose, and says discontinuation "should be strongly considered" for anyone who reports one. Use late in pregnancy can cause sedation and withdrawal in the newborn.
The other direction
The same pregnancy section says observational studies "do not report a clear association with benzodiazepines and major birth defects". The label's warnings describe risks without giving how often they occur at 15 mg for a week, which is the use it was approved for.
What this does not show
It does not tell anyone to stop. Stopping after regular use is exactly what the boxed warning says must be planned, not abrupt.
Worth asking
I have taken this longer than the 7 to 10 days on the label; what is our plan, and what taper would we use if we change it?
Source
RESTORIL (temazepam) capsules: FDA-approved prescribing information, Boxed Warning, Indications and Usage, Dosage and Administration, Warnings — SpecGx LLC; US Food and Drug Administration (2026)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- Industry funded
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 57 out of 100 on our published rubric. One caveat travels with that badge: Approved for 7 to 10 days; the label gives directions of risk without frequencies for that use. 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?
RESTORIL (temazepam) capsules: FDA-approved prescribing information, Boxed Warning, Indications and Usage, Dosage and Administration, Warnings — SpecGx LLC; US Food and Drug Administration (2026). 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: Industry funded. Independence from the proponent is not recorded. 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 temazepam (Restoril), restoril 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.