IMPORTANT SAFETY INFORMATION

Indication and Important Safety Information

What is ZURZUVAE?

ZURZUVAE is a prescription medicine used to treat adults with postpartum depression (PPD).

It is not known if ZURZUVAE is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZURZUVAE?

ZURZUVAE may cause serious side effects, including:

  • Decreased ability to drive or do other dangerous activities. ZURZUVAE may decrease your awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities
    • Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose during your 14-day treatment course of ZURZUVAE
    • You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you
  • Decreased awareness and alertness [central nervous system (CNS) depressant effects].

    ZURZUVAE may cause sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking

    • Because of these symptoms, you may be at a higher risk for falls during treatment with ZURZUVAE
    • Taking alcohol, other medicines that cause CNS depressant effects, or opioids while taking ZURZUVAE can make these symptoms worse and may also cause trouble breathing
    • Tell your healthcare provider if you develop any of these symptoms, or if they get worse during treatment with ZURZUVAE. Your healthcare provider may decrease your dose or stop ZURZUVAE treatment if you develop these symptoms

ZURZUVAE is a federal controlled substance (C-IV) because it contains zuranolone, which can be abused or lead to dependence. Keep ZURZUVAE in a safe place to protect it from theft. Do not sell or give away ZURZUVAE, because it may harm others and is against the law.

Before taking ZURZUVAE, tell your healthcare provider about all of your medical conditions, including if you:

  • drink alcohol
  • have abused or been dependent on prescription medicines, street drugs, or alcohol
  • have liver or kidney problems
  • are pregnant or plan to become pregnant. ZURZUVAE may harm your unborn baby
  • are breastfeeding or plan to breastfeed. ZURZUVAE passes into breast milk, and it is not known if it can harm your baby. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby during treatment with ZURZUVAE

Females who are able to become pregnant:

  • Tell your healthcare provider right away if you become pregnant during treatment with ZURZUVAE
  • You should use effective birth control (contraception) during treatment with ZURZUVAE and for 1 week after the final dose
  • There is a pregnancy registry for females who are exposed to ZURZUVAE during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ZURZUVAE and their baby. If you become pregnant during treatment with ZURZUVAE, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZURZUVAE and some medicines may interact with each other and cause serious side effects. ZURZUVAE may affect the way other medicines work, and other medicines may affect the way ZURZUVAE works.

Especially tell your healthcare provider if you take antidepressants, opioids, or CNS depressants such as benzodiazepines.

What should I avoid while taking ZURZUVAE?

  • Do not drive a car, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose of ZURZUVAE because ZURZUVAE may make you feel sleepy, confused, or dizzy
  • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking ZURZUVAE without talking to your healthcare provider

See “What is the most important information I should know about ZURZUVAE?”

ZURZUVAE may cause serious side effects, including:

See “What is the most important information I should know about ZURZUVAE?”

  • Increased risk of suicidal thoughts or actions. ZURZUVAE and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. ZURZUVAE is not for use in children

How can I watch for and try to prevent suicidal thoughts and actions?

  • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed
  • Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms

Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

  • attempts to commit suicide
  • thoughts about suicide or dying
  • new or worse depression
  • feeling very agitated or restless
  • trouble sleeping (insomnia)
  • new or worse anxiety
  • panic attacks
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • an extreme increase in activity and talking (mania)
  • acting on dangerous impulses
  • other unusual changes in behavior or mood

The most common side effects of ZURZUVAE include:

  • Sleepiness or drowsiness, dizziness, common cold, diarrhea, feeling tired, weak, or having no energy, and urinary tract infection

These are not all of the possible side effects of ZURZUVAE. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.