What to Know About Brexanolone (Zulresso)

A New Drug for Postpartum Depression

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Zulresso is the first drug approved by the Food and Drug Administration (FDA) to treat postpartum depression (PPD). Experts believe that Zulresso (also known by its generic name, brexanolone) improves the symptoms of PPD by interacting with gamma-aminobutyric acid (GABA), a neurotransmitter. In two clinical trials, Zulresso improved symptoms of postpartum depression significantly and rapidly, and its effects lasted for at least 30 days after treatment.

Zulresso is an injectable medication given intravenously (IV) by a healthcare provider in a certified health facility. It is administered continuously over a total of 60 hours or 2.5 days. Your doctor must prescribe and acquire Zulresso for you from Sage Therapeutics, the manufacturer.

Because Zulresso is a controlled substance, the federal government closely monitors its use. No generic form is currently available, so it is only available by the brand name, Zulresso. 

Uses

Zulresso is a treatment for postpartum depression, a condition experienced by about 1 in 8 people who have given birth. Symptoms of postpartum depression include sadness, trouble bonding with the baby, anxious or intrusive thoughts, thoughts of self-harm or harming the baby, irritability, difficulty concentrating. It is one of the most common pregnancy complications faced by people who have given birth.

Traditional antidepressants prescribed for postpartum depression can take weeks to be effective. Since Zulresso is administered directly into a vein, it works much more quickly.

In trials, people with moderate PPD and those with severe PPD showed statistically significant improvement in symptoms within 60 hours of administration. This improvement remained significant at 30 days post-treatment. 

There are no off-label uses of Zulresso reported at this time.

Side Effects

As with any medication, knowing the potential side effects is important. While some side effects are more common than others, patients should note any changes and report it to their health care provider immediately. Common side effects of Zulresso include sleepiness, dizziness, dry mouth, and hot flashes or flushed skin.

An allergic reaction, while rare, can and may occur when taking Zulresso. Symptoms include a rash, hives, itching, wheezing, tightness in the chest or throat, trouble breathing, swallowing, and swelling of the mouth, face, lips, tongue, or throat. Patients taking Zulresso are monitored by a medical professional every two hours while they are awake.

Some clinical trial participants experienced intensified feelings of depression while on Zulresso. If you experience suicidal thoughts or ideation, worsening depression, or any other changes to your mood or outlook, it's essential to let your physician know immediately.

A rare, but severe side effect is excessive sedation and sudden loss of consciousness during treatment. This is another reason why Zulresso is only administered in a healthcare facility with frequent monitoring.

Dosage

Zulresso is only approved for use with adults. A health care provider must be available on-site to continuously monitor the patient, and intervene as necessary, for the duration of the infusion. 

During the 60-hour treatment, the dosage is increased after the first four hours and then again after 24 hours. It is at its highest level during the 24- to 52-hour mark and then is decreased until the treatment is completed.

Modifications

The healthcare provider administering Zulresso will determine if any modifications are necessary. If excessive sedation occurs during treatment, your healthcare provider may stop the infusion until symptoms resolve. Additionally, they may decide to resume treatment at a lower dose. The provider should immediately stop the infusion if monitoring equipment indicates a dip in blood oxygen levels.

Missed Dose

Because Zulresso is only available in a certified healthcare facility, missing a dose is not a concern. Once you receive the 60-hour treatment, no further dosing is needed. 

Interactions 

Taking certain drugs and other substances at the same time as Zulresso may cause adverse reactions. 

Central nervous system depressants like alcohol, opioids, and benzodiazepines may increase the likelihood or severity of adverse reactions to sedation. In some studies, patients taking antidepressants reported sedation after they received Zulresso.

Before using Zulresso, tell your provider about your medications, including vitamins and supplements. Keep a list of all your medications with you, and share the list with your healthcare team. Check with your provider if you have health questions or concerns.

Warnings and Precautions 

Zulresso comes with a black box warning that excessive sedation and sudden loss of consciousness can occur. More specifically, the warning states:

  • Patients are at risk of excessive sedation or sudden loss of consciousness during the administration of Zulresso.
  • Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).
  • Zulresso is available only through a restricted program called the Zulresso REMS.

Currently, the risk of suicidality in patients taking Zulresso is unknown. As with any treatment, if a patient begins to experience suicidal thoughts and behaviors during treatment with Zulresso, treatment should be discontinued.

Until any sedative effects of the drug have dissipated, you should avoid driving or other potentially hazardous activities requiring mental alertness. 

Zulresso is not recommended for people who may be pregnant since it might cause harm to fetuses. Those with kidney disease or other renal problems are not candidates for treatment with Zulresso.

The medication also passes into breast milk. Talk to your healthcare provider about the risks and benefits of breastfeeding and the best way to feed your baby while receiving Zulresso. 

If you are having suicidal thoughts, contact the National Suicide Prevention Lifeline at 988 for support and assistance from a trained counselor. If you or a loved one are in immediate danger, call 911.

Overdose

The facility administering Zulresso will be responsible for any potential issues related to an overdose of the drug. The patient does not handle or administer this drug. A study is underway to determine the safety and efficacy of at-home Zulresso administration. However, no changes have been made to the rule that it must be administered in a certified facility.

If an overdose occurs, you will likely need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

Check with your healthcare provider for additional health information about common problems or adverse side effects associated with this medicine. Call your provider for medical advice about side effects. You also may report side effects to the FDA at 1-800-FDA-1088.

Similar Drugs

Before Zulresso, doctors treated postpartum depression with antidepressants. Some of the more commonly prescribed drugs are serotonin-reuptake inhibitors (SSRIs) which include sertraline (Zoloft) and fluoxetine (Prozac), and serotonin-norepinephrine reuptake inhibitor (SNRI) such as venlafaxine. These may still be effective for some people with PPD.

How to Care for Yourself

The postpartum period is a time of physical and emotional transitions that can lead to feelings of anxiety, depression, and worry. While these emotions can reflect expectable mood swings during this trying time, many people will develop more severe symptoms that result in a diagnosis of postpartum depression.

If you have received this diagnosis, you might be looking for things you can do to help manage the symptoms. In addition to professional treatment that may include psychotherapy, Zulresso, and other medications, there are many ways to help manage the symptoms of depression during the postpartum period.

Tips for Taking Care of Yourself

  • Seek out psychotherapy and counseling
  • Engage in exercise and physical activity
  • Join support groups that allow you to connect with other new moms
  • Get adequate rest
  • Avoid recreational drugs and alcohol
  • Eat a nutritious diet
  • Accept help from family and friends

Most importantly, remember that you are not alone. Postpartum depression can affect anyone, regardless of the number of pregnancies they've had, their age, or their ethnicity. Asking for help is the first step to relieving the symptoms you may be experiencing. 

3 Sources
Verywell Family uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Meltzer-Brody S, Colquhoun H, Riesenberg R, et al. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018;392(10152):1058-1070. doi:10.1016/S0140-6736(18)31551-4

  2. U.S. Food and Drug Administration. Drug trials snapshots: Zulresso.

  3. U.S. Food and Drug Administration. Zulresso prescribing information.

Additional Reading

By Sara Lindberg
Sara Lindberg, M.Ed., is a freelance writer focusing on health, fitness, nutrition, parenting, and mental health.