What is ZTALMY?
ZTALMY is a prescription medicine used to treat seizures associated with
cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in
people 2 years of age and older.
ZTALMY is a federally controlled substance (CV) because it contains
ganaxolone that can be abused and lead to dependence. Keep ZTALMY in a
safe place to prevent misuse and abuse. Selling or giving away ZTALMY
may harm others and is against the law. Tell your healthcare provider if
you or your child have ever abused or been dependent on alcohol,
prescription medicines or street drugs.
It is not known if ZTALMY is safe and effective in children under 2
years of age.
IMPORTANT SAFETY INFORMATION
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.
drive, operate heavy machinery, or do other dangerous activities until you
know how ZTALMY affects you or your child.
Like all other antiepileptic drugs, ZTALMY may
cause suicidal thoughts or actions
in a very small number of people, about 1 in 500.
Call your 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
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
Pay attention to 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 ZTALMY suddenly can cause you or your child to have seizures more
often or seizures that do not stop (status epilepticus).
What should I tell my health care provider?
Before taking ZTALMY, tell your healthcare
provider about all of your or your child’s medical conditions, including
if you or your child:
have or have had depression, mood problems or suicidal thoughts or
have abused or been dependent on prescription medicines, street drugs,
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.
are breastfeeding or plan to breastfeed. ZTALMY may pass into breast
milk. Talk to your healthcare provider about the best way to feed your
or your child’s baby while taking ZTALMY.
Tell your healthcare provider about all the
medicines you or your child take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. ZTALMY may affect the way other medicines work,
and other medicines may affect how ZTALMY works. Do not stop or start
taking other medicines without talking to your healthcare provider.
Especially tell your healthcare provider if you or
your child take:
Know the medicines you or your child take. Keep a list of them to show
your healthcare provider or pharmacist when you or your child get a new
What should be avoided 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.
What are the side effects of ZTALMY?
See "What is the most important information I
should know about ZTALMY?"
The most common side effects of ZTALMY include:
excessive saliva or drooling
These are not all of the possible side effects of ZTALMY. For more
information ask your healthcare provider or pharmacist. Tell your
healthcare provider about any side effect that bothers you or your child
or that does not go away. Call your doctor for medical advice about side
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call
You may also contact Marinus Pharmaceuticals
directly at 1-844-982-5691.
For additional safety information, please click
and discuss with your doctor.