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Overview: Ztalmy is used to treat seizures in people with a rare genetic condition. Common side effects include sleepiness, fever, and drooling. Do not drive or do other activities that require alertness or coordination until you know how Ztalmy affects you. Serious side effects are rare but may include suicidal thoughts or actions. Ztalmy comes as a liquid that you take by mouth.

Uses

What is Ztalmy used for?

Ztalmy (ganaxolone) is commonly used to treat seizures in people with a rare genetic condition called cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).

Ztalmy may also be used for other conditions as determined by your health care provider.

How does Ztalmy work (mechanism of action)?

Seizures are caused by electrical activity in the brain that is not normal. Ztalmy may work by interfering with the abnormal electrical activity of the brain, which helps prevent seizures.

How is Ztalmy supplied (dosage forms)?

Brands and other names

  • Ztalmy

Dosage forms and strengths

  • 50 mg/mL oral suspension

How should I store Ztalmy?

Ztalmy should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). Store it upright in the original bottle and keep the cap tightly closed. It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Throw away any medicine you have not used after 30 days of first opening the bottle.

Side Effects

What are the most common side effects of Ztalmy?

The most common side effects of Ztalmy are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Sleepiness (see below)
  • Fever
  • Excessive saliva (drooling)
  • Seasonal allergies

There may be other side effects of Ztalmy that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ztalmy?

While less common, the most serious side effects of Ztalmy are described below, along with what to do if they happen.

Severe Allergic Reactions. Ztalmy may cause allergic reactions, which can be serious. Stop taking Ztalmy and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Sleepiness. Sleepiness is a common side effect of Ztalmy, and it can sometimes be severe. The risk is higher if Ztalmy is taken with certain other medicines or alcohol. Do not drive or do other activities that require alertness or coordination until you know how Ztalmy affects you. Tell your health care provider right away if you feel very sleepy or have a lack of energy while taking Ztalmy.

Suicidal Thoughts and Actions. Ztalmy, like other seizure medicines, may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Warnings & Precautions

Who should not use Ztalmy?

Allergies to Ingredients. People who are allergic to any of the following should not take Ztalmy.

  • Ganaxolone
  • Ztalmy
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Ztalmy.

What should I know about Ztalmy before using it?

Do not take Ztalmy unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Ztalmy with other people, even if they have the same condition as you. It may harm them.

Keep Ztalmy out of the reach of children. Ztalmy is a controlled substance because it can be misused or lead to dependence. Store Ztalmy in a safe place to protect it from theft. It is illegal to sell or give away this medicine.

Ztalmy should be taken with food.

Read and follow the instructions for Ztalmy and make sure you understand how to prepare and take it properly. Use an accurate measuring device to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Ask your pharmacist to recommend an appropriate measuring device. 

Ztalmy can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Ztalmy affects you.

Do not stop taking Ztalmy without talking to your health care provider. Stopping too quickly may increase the risk of seizures. Call your health care provider right away if you have any seizures.

What should I tell my health care provider before using Ztalmy?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ztalmy is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Mental health problems, such as depression, mood changes, or thoughts of suicide
  • Drink alcohol
  • History of misuse of prescription medicines, street drugs, or alcohol

Other Medicines and Supplements. Ztalmy may interact with other medicines and supplements. Before taking Ztalmy, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Ztalmy could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take Ztalmy while you are pregnant or trying to get pregnant. If you become pregnant while taking Ztalmy, you can sign up for the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334 or at www.aedpregnancyregistry.org. This registry collects safety information about the use of antiepileptic medicines during pregnancy.

Breastfeeding. Ztalmy passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Ztalmy while breastfeeding.

How can I get more information about Ztalmy?

For more information about Ztalmy, visit the manufacturer’s website at www.ztalmy.com or call them at 844-627-4687.

Interactions

Does Ztalmy interact with foods or drinks?

There are no known interactions between Ztalmy and foods or drinks. 

The risk of sleepiness may be increased if you drink alcohol while taking Ztalmy.

Does Ztalmy interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Ztalmy.

  • An opioid, such as codeine, fentanyl, morphine, or oxycodone, which is a medicine used to treat certain types of pain
  • An antidepressant, which is a medicine used to treat depression
  • Any other medicine for seizures, such as carbamazepine, phenobarbital, phenytoin, or primidone
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, or medicines for anxiety

Many other medicines may alter the blood levels of Ztalmy. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Ztalmy. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Ztalmy?

If you or someone else has used too much Ztalmy, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Ztalmy?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.