FDA label
What is Edluar used for?
Edluar contains zolpidem. 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: “Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.”
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Edluar, tablet
Indications and Usage, quoted from the label by Viatris Specialty LLC (NDA021997). Cross-references to other label sections are left out.
Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
The clinical trials performed with zolpidem tartrate 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 a32884d0-85b5-11de-8a39-0800200c9a66, version 22, effective August 15, 2022. NDC 0037-6010, one of 2 listings for this product.
Questions
What is Edluar used for?
The FDA label says: “Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.”
What drug class is Edluar?
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.
More on Edluar
- Is Edluar a controlled substance?Schedule IV
- Generic for EdluarFDA Orange Book
- What is Zolpidem used for?FDA label uses
- Is Zolpidem a controlled substance?Schedule IV
- Generic for Ambien CRFDA Orange Book
- Generic for AmbienFDA Orange Book
- Generic for IntermezzoFDA Orange Book
- Gamma-Aminobutyric Acid A Receptor Positive Modulators listFDA drug class
- NDC 0037-6010Edluar NDC record
- NDC 0037-6050Edluar NDC record
- Schedule IV drugs listDEA schedule