Zulresso (Brexanolone): Uses, Dosage, Side Effects, & More

What Is Zulresso (Brexanolone) & How Is It Used?

Zulresso is an antidepressant and a controlled substance. Controlled substances have the potential to be abused and the potential for drug dependence. Patients taking this medicine will be monitored closely to ensure they do not misuse, abuse, or become addicted to this medication. Zulresso is approved for ages 15 and older, and a healthcare professional will be available for the entire treatment.¹

What is Zulresso Used to Treat?

Zulresso is FDA-approved to treat depression suffered by a parent following childbirth, also known as postpartum depression (PPD). Postpartum depression (PPD) can make new parents feel sad, worried, and overwhelmed after having a baby.

Zulresso is FDA-approved as a medication to treat PPD. When a medication is FDA-approved, it means that experts from the FDA have checked it and verified that the medication is safe and works well for certain medical conditions. There are no other uses for this medication at this time. This medication is not approved for use in children under the age of 15.¹

How Does Zulresso Work?

Zulresso works by targeting a certain chemical in the brain called GABA, which is a neurotransmitter. Zulresso works to balance these chemicals, which help to balance a person’s mood and emotions, improving postpartum depression symptoms.¹

How Effective is Zulresso in Treating Postpartum Depression?

Zulresso decreases symptoms of depression and can quickly make people feel less depressed (feeling sad, anxious, irritable, or having thoughts of hurting themselves). This improvement continues for at least 30 days.  Research has not looked at the effects of Zulresso after 30 days, so it is unknown if these effects continue for longer than 30 days.^{2, 3}

Side Effects of Zulresso

When starting Zulresso, monitor for signs of extreme sleepiness. While getting a Zulresso infusion, tell your healthcare provider right away if you feel like you cannot stay awake during the time of day you are normally awake or if you feel like you are going to faint. Your healthcare provider may lower your Zulresso dose or pause the infusion until your symptoms go away.¹

Common Side Effects of Zulresso

Some patients experience side effects while taking Zulresso. If you are experiencing a side effect not listed below, or if you do not know if what you are experiencing is a side effect of Zulresso, tell your doctor who is monitoring your infusion. Although rare, some individuals have very bad and sometimes deadly side effects when taking Zulresso. Tell your provider or get medical help right away if you notice signs of an allergic reaction or changes or an increase in suicidal thoughts.¹

Common side effects of Zulresso include:¹

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

*All medications, including Zulresso, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor or pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.

Allergic Reactions to Zulresso

Your healthcare provider will look for signs of an allergic reaction while receiving your Zulresso infusion. Common signs of an allergic reaction include hives, rash, and/or itching.¹

Signs of an allergic reaction to Zulresso may include:¹

• Red or discolored, swollen, blistered, or peeling skin with or without fever
• Wheezing
• Tightness in the chest or throat
• Trouble breathing, swallowing, or talking
• Unusual hoarseness
• Swelling of the mouth, face, lips, tongue or throat

If you experience any of these symptoms, immediately tell your healthcare provider who is monitoring your infusion.

Zulresso Warnings and Precautions

Zulresso may make you feel very sleepy, or you may pass out. It is important to let your healthcare provider who is monitoring your infusion if you start to experience either of these symptoms. If you do experience them, your provider may lower the dose or stop the infusion until your symptoms go away. Zulresso’s risk of serious harm resulting from excessive sedation or sudden loss of consciousness requires patients to get Zulresso through a restricted program called Zulresso REMS. Your doctor will help ensure that everything is submitted for the REMS program so you can receive your Zulresso infusion.¹

If you experience any changes in mood, behavior, or feelings, or if you experience thoughts of self-harm, tell your healthcare provider who is monitoring your infusion immediately. Zulresso may increase the possibility of these changes.¹

Warnings and precautions for Taking Zulresso Include:^{1, 2}

Excessive Sedation & Loss of Consciousness

Zulresso may cause you to feel very sleepy or pass out. Due to this risk, you must have a caregiver or family member with you to help care for your children at all times during your infusion.

Suicidal Thoughts & Behaviors

Zulresso and other antidepressant medications may increase suicidal thoughts and actions in some patients 24 years old and younger. Call 911 or go to the emergency room (ER) if you notice any warning signs of suicide, or have new depression or depression that is getting worse.

Pregnancy

If you are pregnant or could be pregnant, avoid using Zulresso. Zulresso may cause harm to your unborn baby.

End-stage Renal Disease

If you have kidney problems, talk to your doctor or pharmacist before using Zulresso.

Interactions With Zulresso

There are potentially harmful interactions Zulresso can have with medications, substances, and herbs. The medications listed below may affect how Zulresso works in your body. Your healthcare providers may adjust the doses of your other medications while you are taking Zulresso.

Some substances you may need to avoid while taking Zulresso include:¹

• Alcohol: Alcohol may enhance the effects of both substances.
• Opioids: Opioids may increase the chance and worsen side effects related to sleepiness.
• Other CNS depressants: Other CNS depressants (like benzodiazepines) may increase the chance and worsen side effects related to sleepiness.
• Other antidepressants: Taking Zulresso and another antidepressant may increase the chance of side effects related to sleepiness.
• Azelastine (nasal spray): Azelastine can enhance the effects of Zulresso.⁵

This is not a complete list of interactions that are possible with Zulresso. Be sure to tell your doctor about all medications, herbs, and supplements you are taking before receiving your Zulresso infusion.

Zulresso Dosages for Postpartum Depression (PPD)

Zulresso is only FDA-approved for the treatment of postpartum depression. The dosing of this medication is based on each patient’s weight. If patients experience any side effects, their healthcare provider may adjust the dosing for the remainder of the infusion.¹

Zulresso Form & Strength

Zulresso is currently only available as a solution for injection. The solution must be diluted before use. The strength of the solution is 100 mg in a 20 ml per vial. Doses may vary depending on individual patient factors, including how much the person weighs, how each person reacts to the medicine, other medicines the patient is taking that may interact with Zulresso, and any other medical conditions the person has. Zulresso will start working very quickly after the medication is given.¹

How Zulresso is Given

Zulresso is given as an ongoing infusion into your vein for 60 hours or 2.5 days. During your infusion, a healthcare provider will be there to monitor and help if needed. It is important to start your Zulresso treatment early in the day so your healthcare providers have time to notice if you become sleepy. Your providers will check in every 2 hours while you are awake to see if you feel too drowsy, as well as check on your breathing and oxygen levels.¹

The recommended dosage of Zulresso for PPD is:¹

• Start of infusion to 4 hours: Start with a dosage of 30 mcg/kg/hour
• Hours 4 through 24: Increase dosage to 60 mcg/kg/hour
• Hours 24 through 52: Increase dosage to 90 mcg/kg/hour (may reduce dosage to 60 mcg/kg/hour for patients who do not tolerate 90 mcg/kg/hour)
• Hours 52 through 56: Decrease dosage to 60 mcg/kg/hour
• Hours 56 through 60: Decrease dosage to 30 mcg/kg/hour

Zulresso FAQs

Common questions patients may have regarding Zulresso may surround topics around pregnancy and breastfeeding, precautions to take, and the cost of Zulresso. These questions, in addition to common questions and their answers, are listed below.

Is Zulresso Safe for Breastfeeding Women?

There is limited information available on the full risks of breastfeeding while on Zulresso. Zulresso may pass through the breast milk; however, the expected infant dose would be very small. It is recommended to talk to your healthcare provider about the risks and benefits of receiving Zulresso while breastfeeding before starting this medication.^{1, 6}

Is Zulresso a Controlled Substance?

Yes, Zulresso is a controlled substance. It is a schedule IV controlled medication and requires close monitoring while being administered due to the risk of abuse and dependence.¹

What Should I Avoid While Receiving Zulresso?

Zulresso may make you feel sleepy or tired. Do not drive or participate in any dangerous activities after your infusion until you are sure these effects have gone away. It is important to avoid alcohol while receiving this medication.¹

Can I Use Zulresso if I Have Kidney Problems?

It depends. If your kidney problems are severe, you may need a different medication. Your doctor will be able to help you determine if Zulresso is safe for you; make sure to tell them about any health conditions you have before receiving a Zulresso infusion.¹

Zulresso Costs & Insurance Coverage

Zulresso is estimated to cost around $34,000 for the whole infusion. Still, each individual’s cost depends on how many vials of medication will be needed to complete the infusion based on their unique doses. Some insurance may cover Zulresso. There are several cost savings programs available on the Zulresso website that you may qualify for.⁷

Reproductive Considerations

Do not use Zulresso if you are pregnant or think you may be pregnant. It is unknown if Zulresso will harm your unborn baby. There is a pregnancy registry available for mothers who are receiving Zulresso and are pregnant, with the goal of gathering information about the health of women and their babies. Talk to your healthcare provider if you become pregnant during your Zulresso treatment.¹

Questions to Ask Your Healthcare Provider About Zulresso

If you are having symptoms of postpartum depression, reach out to your healthcare provider as soon as possible. Ask your doctor or pharmacist if Zulresso is the best option for you. If started on Zulresso, make sure to look for any signs of sleepiness, feeling like you are about to pass out, and new or worsening suicidal thoughts or behaviors. Make sure to talk to your doctor, psychiatrist, and/or therapist before starting this medication.

Questions to ask your healthcare team about Zulresso include:

• How long will it take for me to adjust to Zulresso?
• Am I at risk for more severe symptoms if I am already taking other anxiety/depression medications?
• What is the best dosage to ensure fewer side effects?
• Is there anything I should tell my therapist about this new medication?
• Where can I get the Zulresso infusion?
• How soon might I notice side effects while receiving Zulresso?
• What if my symptoms get worse while taking Zulresso?
• How long does it take Zulresso to start working?

In My Experience

In my experience, it is important to let your healthcare providers know as soon as you notice any symptoms of postpartum depression. Postpartum depression can be debilitating for new mothers. Finding the right therapist, provider, and pharmacist can also be very beneficial for you. Your healthcare providers may also connect you with local support groups with other mothers with postpartum depression.

Zulresso may be more difficult to access than other medications, but it could be very beneficial for treating your symptoms, and your providers can get you in contact with the right people to assist with access and cost. Please talk to your provider about any concerns you have about this medication before, during, and after your infusion.