FDA label
What is Restoril used for?
Restoril contains temazepam. The FDA-approved uses below are 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: “Restoril® (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days).”
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Restoril, capsule
Indications and Usage, quoted from the label by SpecGx LLC (NDA018163). Cross-references to other label sections are left out.
Restoril® (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 Restoril® (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 bc56f7fd-1aaf-48ff-8aa7-d467e59e1015, version 25, effective June 9, 2026. NDC 0406-9914, one of 4 listings for this product.
Questions
What is Restoril used for?
The FDA label says: “Restoril® (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days).”
What drug class is Restoril?
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 Restoril
- Is Restoril a controlled substance?Schedule IV
- Generic for RestorilFDA Orange Book
- What is Temazepam used for?FDA label uses
- Is Temazepam a controlled substance?Schedule IV
- Benzodiazepines listFDA drug class
- NDC 0406-9914Restoril NDC record
- NDC 0406-9915Restoril NDC record
- NDC 0406-9916Restoril NDC record
- Schedule IV drugs listDEA schedule