What Is Zolpidem Used For? FDA-Approved Uses

The FDA label says: “Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.”

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Zolpidem Tartrate, tablet

Indications and Usage, quoted from the label by Torrent Pharmaceuticals Limited (ANDA077903). Cross-references to other label sections are left out.

Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Source: DailyMed label, set id 1584bad1-7bf4-4805-bdd9-7eb0fac92721, version 27, effective September 1, 2026. NDC 13668-007, one of 55 listings for this product.

Zolpidem Tartrate, tablet, film coated

Indications and Usage, quoted from the label by The ACME Laboratories Ltd. (ANDA077214). Cross-references to other label sections are left out.

Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.
The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Source: DailyMed label, set id 5679ed64-8424-4e63-a3c9-91d80fff2ca6, version 2, effective March 4, 2026. NDC 72722-103, one of 32 listings for this product.

Zolpidem Tartrate, tablet, extended release

Indications and Usage, quoted from the label by Breckenridge Pharmaceutical, Inc. (ANDA213592). Cross-references to other label sections are left out.

Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration.

Source: DailyMed label, set id cbda91f7-4411-4016-80d6-0a349931956d, version 8, effective August 26, 2026. NDC 51991-981, one of 24 listings for this product.

Questions

What is zolpidem used for?

The FDA label says: “Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.”

What drug class is zolpidem?

FDA lists zolpidem in the gamma-Aminobutyric Acid A Receptor Positive Modulator 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.