ZULRESSO can cause serious side effects, including:

Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness) during treatment. Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake.

• During your ZULRESSO infusion, tell your healthcare provider right away if you feel like you cannot stay awake during the time you are normally awake or if you feel like you are going to pass out. Your healthcare provider may stop the infusion until your symptoms go away, then determine if it is necessary to lower your dose
• You must have a care partner or family member with you to help care for your child(ren) during your ZULRESSO infusion

Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is only available through a restricted program called the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS).

Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. Depression or other serious mental illnesses are the most significant causes of suicidal thoughts or actions.

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
• 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:

• Attempts to commit suicide
• Thoughts about suicide or dying
• New or worse depression
• Other unusual changes in behavior or mood

What are the most common side effects of ZULRESSO?

The side effects that were most common among women who took ZULRESSO were:

• Sleepiness
• Dry mouth
• Passing out
• Flushing of the skin or face

These are not all the side effects of ZULRESSO. For more information, speak with your healthcare provider.

Because of the risk of serious harm resulting from extreme sleepiness (excessive sedation) or passing out (loss of consciousness) during treatment, mothers will be monitored by a healthcare provider in a healthcare setting.

Speak with your healthcare provider if you experience any side effects or have any questions, or to learn if ZULRESSO is right for you.

Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:

• Drink alcohol
• Have kidney problems
• Are pregnant or think you may be pregnant. It is not known if ZULRESSO will harm your unborn baby
  • There is a pregnancy registry for people who are exposed to ZULRESSO during pregnancy. The purpose of the registry is to collect information about the health of people exposed to ZULRESSO and their baby. If you become pregnant during treatment with ZULRESSO, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1‑844‑405‑6185 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
• Are breastfeeding or plan to breastfeed. ZULRESSO passes into breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby while receiving ZULRESSO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ZULRESSO and some medicines may interact with each other and cause serious side effects.

Especially tell your healthcare provider if you take:

• Other antidepressants
• Opioids
• CNS depressants such as benzodiazepines

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.

What else to know about ZULRESSO: ZULRESSO may make you feel dizzy and sleepy. Do not drive a car or do other dangerous activities after your ZULRESSO infusion until your feeling of sleepiness has completely gone away. Do not drink alcohol while receiving ZULRESSO.