Quick answers
- What is Temazepam used for?
- The FDA-approved label (Restoril, SpecGx LLC, June 9, 2026) says: “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). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Temazepam have a boxed warning?
- Yes. The FDA label for Restoril has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Temazepam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Temazepam been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Temazepam?
- 22 companies list prescription products of Temazepam in the FDA NDC Directory, including Bryant Ranch Prepack, SpecGx LLC and Aphena Pharma Solutions - Tennessee, LLC.
What Temazepam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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). …
— FDA label: Restoril, SpecGx LLC, effective June 9, 2026. Read the full label on DailyMed →
The FDA has 47 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
42 of 47 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 88 in the FDA NDC Directory |
| Brand names | Restoril |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| temazepam 15 mg capsule | Generic | $0.0729 per capsule |
| temazepam 22.5 mg capsule | Generic | $1.58 per capsule |
| temazepam 30 mg capsule | Generic | $0.0879 per capsule |
| temazepam 7.5 mg capsule | Generic | $0.8293 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack21 products
- SpecGx LLC8 products
- Aphena Pharma Solutions - Tennessee, LLC7 products
- Alembic Pharmaceuticals Limited4 products
- Amneal Pharmaceuticals LLC4 products
- Alembic Pharmaceuticals Inc.4 products
- Asclemed USA, Inc.4 products
- Ascend Laboratories, LLC4 products
- Proficient Rx LP4 products
- Solco Healthcare U.S., LLC4 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Preferred Pharmaceuticals Inc.3 products
- AvPAK2 products
- Golden State Medical Supply, Inc.2 products
- Actavis Pharma, Inc.2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- A-S Medication Solutions2 products
- Amneal Pharmaceuticals of New York LLC2 products
- NuCare Pharmaceuticals, Inc.2 products
- Remedyrepack Inc.2 products
- Major Pharmaceuticals1 product
- American Health Packaging1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018163 RESTORIL | Specgx LLC | February 27, 1981 | 53, latest January 13, 2023 2023: Labeling · 2021: Labeling · 2019: Labeling |
Generic approvals (7)
- ANDA071456Novel Labs Inc · April 21, 1987
- ANDA071457Novel Labs Inc · April 21, 1987
- ANDA071620Actavis Elizabeth · August 7, 1987
- ANDA201781Prinston Inc · June 4, 2015
- ANDA203482Amneal Pharms · May 23, 2016
- ANDA211542Alembic · November 23, 2018
- ANDA071638—
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Restoril, SpecGx LLC, effective June 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →