FDA label
What is Ztalmy used for?
Ztalmy contains ganaxolone. 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: “ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.”
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Ztalmy, suspension
Indications and Usage, quoted from the label by Immedica Pharma US Inc (NDA215904). Cross-references to other label sections are left out.
ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
Source: DailyMed label, set id d91612c4-b03a-4be4-a1ee-6a13e3b83d4e, version 14, effective September 4, 2026. NDC 81583-100, one of 1 listing for this product.
Questions
What is Ztalmy used for?
The FDA label says: “ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.”
What drug class is Ztalmy?
FDA lists ganaxolone in the Neuroactive Steroid 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.