Quick answers
- What is Zaleplon used for?
- The FDA-approved label (Zaleplon, PD-Rx Pharmaceuticals, Inc., October 17, 2025) says: “Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Zaleplon have a boxed warning?
- Yes. The FDA label for Zaleplon has a boxed warning (“WARNING: COMPLEX SLEEP BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Zaleplon?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Zaleplon been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Zaleplon?
- 9 companies list prescription products of Zaleplon in the FDA NDC Directory, including Bryant Ranch Prepack, PD-Rx Pharmaceuticals, Inc. and Unichem Pharmaceuticals (USA), Inc..
What Zaleplon is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. …
— FDA label: Zaleplon, PD-Rx Pharmaceuticals, Inc., effective October 17, 2025. Read the full label on DailyMed →
The FDA has 15 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. Its heading: WARNING: COMPLEX SLEEP BEHAVIORS
. Read it on the full label →
15 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 20 in the FDA NDC Directory |
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 |
|---|---|---|
| zaleplon 10 mg capsule | Generic | $0.1491 per capsule |
| zaleplon 5 mg capsule | Generic | $0.1558 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 Prepack4 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Unichem Pharmaceuticals (USA), Inc.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Aurobindo Pharma Limited2 products
- Preferred Pharmaceuticals Inc.2 products
- Rising Pharma Holdings, Inc.2 products
- Bionpharma Inc.2 products
- A-S Medication Solutions1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA077237Hikma · June 6, 2008
- ANDA078829Aurobindo Pharma · June 6, 2008
- ANDA078989Unichem · June 6, 2008
- ANDA090374Orbion Pharms · September 17, 2009
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
| RxCUI (RxNorm) | 313761, 313762 |
|---|---|
| SPL set ID of the quoted label | a1277ef5-6072-43ff-a6ce-0a7cea58b7cb |
| FDA labels (SPL) | 15 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | ZALEPLON |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zaleplon, PD-Rx Pharmaceuticals, Inc., effective October 17, 2025; 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 →