In clinical studies, treatment with ZULRESSO was completed in 2.5 days.
ZULRESSO is given to you by a continuous intravenous (IV) infusion into your vein over the course of 2.5 days. 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
- CNS depressants such as benzodiazepines
Tell your doctor 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 females who are exposed to ZULRESSO during pregnancy. The purpose of the registry is to collect information about the health of females 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/
If you're considering breastfeeding while taking ZULRESSO, please talk to your doctor.
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 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
Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts or 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, 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:
- 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.
You may have questions about the ZULRESSO infusion before beginning treatment. Your doctor and the team at your healthcare setting should be your primary resources for any questions regarding treatment with ZULRESSO. ZULRESSO must be administered in a certified healthcare setting so that a doctor or other healthcare professional will be present to monitor you throughout treatment.
In addition, Sage Central is your source for patient support resources and programs, providing information and personalized 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 .
Before starting treatment, make sure to:
- Talk to your doctor about any concerns or questions you may have
- Choose someone close to you, like a partner or other loved one, and let them know ways in which they can help during treatment
You must have a caregiver or family member 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.