What Is Ambien Used For? FDA-Approved Uses

The FDA label says: “AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.”

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Ambien, tablet, film coated

Indications and Usage, quoted from the label by Sanofi-Aventis U.S. LLC (NDA019908). Cross-references to other label sections are left out.

AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN 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 c36cadf4-65a4-4466-b409-c82020b42452, version 26, effective April 15, 2025. NDC 0024-5401, one of 3 listings for this product.

Ambien, tablet, coated

Indications and Usage, quoted from the label by Cosette Pharmaceuticals, Inc. (NDA021774). Cross-references to other label sections are left out.

AMBIEN CR (zolpidem tartrate extended-release tablets) is 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 [see Clinical Studies].

Source: DailyMed label, set id 2d934da3-bd77-4470-e063-6294a90a64f5, version 1, effective February 7, 2025. NDC 0713-5501, one of 2 listings for this product.

Questions

What is Ambien used for?

The FDA label says: “AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.”

What drug class is Ambien?

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.