What to Know About Brexanolone (Zulresso)

A New Drug Approved Specifically for Postpartum Depression

mom and baby

Zulresso, also known by its generic name, brexanolone, is the first drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adult women. It is believed to interact with the GABA or gamma-aminobutyric acid system, which may help treat postpartum depression. In two clinical trials, Zulresso was shown to significantly and rapidly improve the symptoms of postpartum depression, and its effects lasted for at least 30 days after treatment.

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

Since 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. 

Side Effects

More Common

Common side effects of Zulresso include the following:

  • Sleepiness
  • Dizziness
  • Passing out or feeling like you’re going to faint
  • Dry mouth
  • Flushed skin or face 

Less Common

An allergic reaction, while rare, can and may occur when taking Zulresso. Symptoms include a rash, hives, itching, wheezing, tightness in chest or throat, trouble breathing, swallowing, 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.

Severe

  • Excessive sedation and sudden loss of consciousness during treatment

Uses 

In March 2019, the FDA approved the use of Zulresso specifically for the treatment of postpartum depression. Zulresso is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression in adults.

Antidepressants, which are prescribed for depression, can take weeks to be effective. Since Zulresso is administered via an intravenous infusion over 60 hours or 2.5 days, it can work within a few days. In trials, women with moderate PPD and those with severe PPD showed statistically significant improvement in symptoms that were nearly to remission based on the HAM-D (a test used for research purposes to determine severity of illness). This improvement was seen at the 60 hour mark and remained significant at 30 days post treatment. 

Off-Label Uses

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

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. 

According to the manufacturer, a health care provider will administer Zulresso as a continuous intravenous infusion over 60 hours (2.5 days). 

Modifications

Any modifications will be determined by the provider administering the drug. If excessive sedation occurs during treatment, your health care 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 pulse oximetry reveals hypoxia.

Missed Dose

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

Interactions 

Certain drugs and other substances that are taken at the same time as Zulresso may cause adverse reactions. 

  • CNS depressants such as opioids and benzodiazepines may increase the likelihood or severity of adverse reactions to sedation. This also includes alcohol.
  • During placebo-controlled studies, patients also taking antidepressants reported sedation-related events. 

This document does not contain all possible interactions or health implications. Therefore, before using this medicine, tell your doctor of all the medications you use. Keep a list of all your medications with you, and share the list with your doctor. Check with your doctor 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 any other potentially hazardous activities requiring mental alertness. 

If you are having suicidal thoughts, contact the National Suicide Prevention Lifeline at 1-800-273-8255 for support and assistance from a trained counselor. If you or a loved one are in immediate danger, call 911.

How to Take Zulresso

Zulresso is only available through a restricted program called the Zulresso REMS, in which a health care provider will carefully monitor you at a certified health care facility. They will administer the drug as a continuous intravenous infusion over a total of 60 hours. You will remain at the facility during the duration of the administration. 

Storage

Zulresso is stored at certified health care facilities participating in a restricted program called the Zulresso REMS. Patients do not need to be concerned with handling or storing this drug. 

Contraindications

  • Patients with end-stage renal disease should avoid Zulresso.
  • Zulresso may cause fetal harm during pregnancy. At this time, there is no available data on its use in pregnant women.
  • The manufacturer does state that Zulresso passes into breast milk. Therefore, talk to your health care provider about the risks and benefits of breastfeeding and about the best way to feed your baby while receiving Zulresso. 

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.

If an overdose occurs, call your doctor or 911. You'll likely need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

This document does not contain all possible side effects and other serious side effects may occur. Check with your doctor for additional health information about common problems or negative side effects associated with this medicine. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Similar Drugs

Prior to Zulresso, postpartum depression was often treated with antidepressants. Some of the more commonly prescribed drugs include:

  • Serotonin-reuptake inhibitors (SSRIs) which includes, sertraline (Zoloft) and fluoxetine (Prozac)
  • Serotonin-norepinephrine reuptake inhibitor (SNRI) such as venlafaxine

How to Stay Healthy

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 women 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 including:

  • Psychotherapy and counseling
  • Exercise and physical activity
  • Support groups that allow you to connect with other new moms
  • Adequate rest
  • Avoiding recreational drugs and alcohol
  • Healthy diet and nutrition
  • Accepting help from family and friends

Most importantly, remember that you are not alone. Postpartum depression can affect any woman, regardless of the number of pregnancies, age, or ethnicity. Asking for help is the first step to finding ways to relieve some of the symptoms you may be experiencing. 

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  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

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