FDA label
What is temazepam used for?
The FDA-approved uses of temazepam, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days).”
Run it in Rivvi
Which 2027 plans near you dropped or restricted temazepam?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Temazepam, capsule
Indications and Usage, quoted from the label by Solco Healthcare U.S., LLC (ANDA201781). Cross-references to other label sections are left out.
Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days).
For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days).
The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
Source: DailyMed label, set id 3ce42f0e-821e-4c9a-8f6b-60621628fd4b, version 6, effective July 25, 2024. NDC 43547-611, one of 75 listings for this product.
Questions
What is temazepam used for?
The FDA label says: “Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days).”
What drug class is temazepam?
FDA lists temazepam in the Benzodiazepine established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Temazepam
- Is Temazepam a controlled substance?Schedule IV
- Generic for RestorilFDA Orange Book
- What is Restoril used for?FDA label uses
- Is Restoril a controlled substance?Schedule IV
- Benzodiazepines listFDA drug class
- NDC 0406-9914Temazepam NDC record
- NDC 0406-9915Temazepam NDC record
- NDC 0406-9916Temazepam NDC record
- Schedule IV drugs listDEA schedule