Prescription medicine
Ganaxolone Brand names: Ztalmy
Ganaxolone (Ztalmy) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
- DEA Schedule V
Check it at the source: the ganaxolone FDA label on DailyMed (effective November 28, 2025, Immedica Pharma US Inc); the NDA 215904 record on Drugs@FDA; every ganaxolone label on DailyMed.
Highlights of the record
FDA label of November 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZTALMY 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.
Forms and strengths
- 50 mg/ml
Suspension.
On the market
- Earliest approval on file
- March 18, 2022 Ztalmy, Immedica Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 30, 2042 Ztalmy oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is ganaxolone used for?
From the label: indications and usageZTALMY 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. ZTALMY is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator 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.
FDA pharmacologic class: Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator.
Source: FDA drug label (ZTALMY), Immedica Pharma US Inc, effective November 28, 2025 (SPL set d91612c4-b03a-4be4-a1ee-6a13e3b83d4e), via openFDA; the full label on DailyMed
What does the patient leaflet for ganaxolone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZTALMY?ZTALMY can cause serious side effects, including: ZTALMY may cause sleepiness. Taking ZTALMY with central nervous system (CNS) depressants including alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ZTALMY affects you or your child. Like other antiepileptic drugs, ZTALMY may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you or your child have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempt to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Do not stop taking ZTALMY without first talking to your healthcare provider. Stopping a seizure medicine such as ZTALMY suddenly can cause you or your child to have seizures more often or seizures that do not stop (status epilepticus). Call your healthcare provider between visits as needed, especially if you are worried about symptoms. WHAT IS ZTALMY? ZTALMY is a prescription medicine that is used to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in people 2 years of age and older. […]
From the patient leaflet: What should I avoid while taking ZTALMY?Do not drive, operate heavy machinery, or do other dangerous activities until you know how ZTALMY affects you or your child. ZTALMY may cause you or your child to feel sleepy.
From the patient leaflet: How should I store ZTALMY?Store ZTALMY at 68°F to 77°F (20°C to 25°C). Always store ZTALMY in its original bottle in an upright position. Keep the child-resistant cap tightly closed. Use ZTALMY within 30 days of first opening the bottle. Throw away (dispose of) any unused medicine after 30 days. Keep ZTALMY and all medicines out of the reach of children. General Information about the safe and effective use of ZTALMY. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZTALMY for a condition for which it was not prescribed. Do not give ZTALMY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZTALMY that is written for health professionals.
Source: FDA drug label (ZTALMY), Immedica Pharma US Inc, effective November 28, 2025 (SPL set d91612c4-b03a-4be4-a1ee-6a13e3b83d4e), via openFDA; the full label on DailyMed
Is there a generic for ganaxolone (Ztalmy)?
No generic ganaxolone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 11 patents for Ztalmy oral suspension, the last expiring on September 30, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ganaxolone label say about other medicines?
The ganaxolone label names 6 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | In patients on a stable ZTALMY dosage who are initiating or increasing the dosages of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, phenobarbital, and primidone), the ZTALMY dosage may need to be increased; … |
| Divalproex | drug interactions | Inhibitors on ZTALMY Concomitant use of ZTALMY and UGT inhibitors (e.g., valproic acid) may increase the exposure of ganaxolone, which may increase the risk of ZTALMY associated adverse reactions in patients who have titrated to a stable ZTALMY dosage. |
| Phenobarbital | drug interactions | In patients on a stable ZTALMY dosage who are initiating or increasing the dosages of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, phenobarbital, and primidone), the ZTALMY dosage may need to be increased; … |
| Phenytoin | drug interactions | In patients on a stable ZTALMY dosage who are initiating or increasing the dosages of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, phenobarbital, and primidone), the ZTALMY dosage may need to be increased; … |
| Primidone | drug interactions | In patients on a stable ZTALMY dosage who are initiating or increasing the dosages of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, phenobarbital, and primidone), the ZTALMY dosage may need to be increased; … |
| Valproic acid | drug interactions | Inhibitors on ZTALMY Concomitant use of ZTALMY and UGT inhibitors (e.g., valproic acid) may increase the exposure of ganaxolone, which may increase the risk of ZTALMY associated adverse reactions in patients who have titrated to a stable ZTALMY dosage. |
Source: FDA drug label (ZTALMY), Immedica Pharma US Inc, effective November 28, 2025 (SPL set d91612c4-b03a-4be4-a1ee-6a13e3b83d4e), via openFDA; the full label on DailyMed
What next?
- Other neuroactive steroid gamma-aminobutyric acid a receptor positive modulators
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other