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In clinical studies, treatment with ZULRESSO was completed in 2.5 days.

ZULRESSO is administered into your vein by a continuous intravenous (IV) infusion. The infusion lasts 2.5 days, and treatment will take place in a REMS-certified hospital or other healthcare setting. Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness during treatment, ZULRESSO is only available through a restricted program called the ZULRESSO REMS in which a healthcare provider will carefully monitor you at a certified healthcare facility.

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

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

Especially tell your healthcare provider if you take:

• Other antidepressants
• Opioids
• CNS depressants such as benzodiazepines

Tell your healthcare provider if you drink alcohol or have kidney problems. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.

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

If you’re considering breastfeeding while taking ZULRESSO, please speak with your healthcare provider.

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

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

The most common side effects of ZULRESSO include:

• Sleepiness

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

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

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. But there may also be other things you need to avoid; speak with your healthcare provider.

You may have questions about the ZULRESSO infusion before beginning treatment. Your doctor and the team at your Treating Center should be your primary resources for any questions regarding treatment with ZULRESSO. ZULRESSO must be administered in a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare setting so that a doctor or other healthcare provider will be present to monitor you throughout treatment.

In addition, Sage Central is your source for patient support resources and programs, providing information and support to help navigate the treatment journey.

Sage Central provides financial assistance options to eligible patients. Once you are enrolled in Sage Central, you will be automatically enrolled in the financial assistance programs for which you may be eligible. Your continued eligibility is subject to the satisfaction of the terms and conditions for the financial assistance programs. For more information, including terms and conditions, visit the Sage Central website.