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

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). 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 lower your dose or stop the infusion until your symptoms go away.
  • You must have a caregiver 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 REMS.

What is ZULRESSO?

ZULRESSO is a prescription medicine used to treat a certain type of depression called Postpartum Depression in individuals 15 years and older.

It is not known if ZULRESSO is safe and effective in individuals less than 15 years of age.

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 women who are exposed to ZULRESSO during pregnancy. The purpose of the registry is to collect information about the health of women 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.

How will I receive ZULRESSO?

• ZULRESSO is given to you by continuous intravenous (IV) infusion into your vein. Your ZULRESSO infusion will last for a total of 60 hours (2.5 days).

What should I avoid while receiving 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. See "What is the most important information I should know about ZULRESSO?"
• Do not drink alcohol while receiving ZULRESSO.

What are the possible side effects of ZULRESSO?

ZULRESSO can cause serious side effects, including:

• See "What is the most important information I should know about ZULRESSO?"
• 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 important 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, especially if they are new, worse, or worry you:

  • 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about ZULRESSO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about ZULRESSO that is written for health professionals.

What are the ingredients in ZULRESSO?

Active ingredient: brexanolone

Inactive ingredients: betadex sulfobutyl ether sodium, citric acid monohydrate, sodium citrate dihydrate, and water for injection. Hydrochloric acid or sodium hydroxide may be added during manufacturing to adjust pH.

Manufactured for:

Sage Therapeutics, Inc.,

Cambridge, MA 02142

ZULRESSO, the ZULRESSO logo, SAGE THERAPEUTICS, and the SAGE THERAPEUTICS logo are registered trademarks of Sage Therapeutics, Inc. All other trademarks referenced herein are the properties of their respective owners.

For more information about ZULRESSO go to www.zulresso.com or call 844-472-4379.