Ztalmy

Generic name:ganaxolone
Dosage form: oral suspension
Drug class:Gamma-aminobutyric acid analogs

Medically reviewed by Judith Stewart, BPharm. Last updated on Mar 21, 2022.

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.
• [There is a pending DEA decision for control of Ztalmy (ganaxolone) under the Controlled Substances Act. A statement for patients about abuse and dependence risks cannot be completed at this time.]
• It is not known if this medicine is safe and effective in children under 2 years of age.

Important information

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 treatment without first talking to your healthcare provider. Stopping a seizure medicine 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.

Before taking Ztalmy

Before you start treatment, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

• drink alcohol.
• have or have had depression, mood problems, or suicidal thoughts or behavior.
• have abused or been dependent on prescription medicines, street drugs, or alcohol.
• have liver problems.
• are pregnant or plan to become pregnant. Tell your healthcare provider right away if you or your child become pregnant while taking Ztalmy. You and your healthcare provider will decide if you or your child should take Ztalmy while pregnant.
  • if you or your child