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Warnings and Interactions

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Zulresso(its generic name isbrexanolone) is an antidepressant specifically designed to treatpostpartum depression (PPD)in adult women. It is administered under medical supervision as an infusion, typically over a 60-hour time frame. It belongs to a class of drugs known asneuroactive steroid gamma-aminobutyric acids(GABAs).

Zulresso is available as a solution for intravenous infusion, and its active ingredient is brexanolone.

Zulresso is currently only available through a program called Zulresso Risk Evaluation and Mitigation Strategy (Zulresso REMS).

What is the most important information I should know about Zulresso?You should not take Zulresso if:you have kidney disease; oryou have a known allergy to brexanolone or other active and inactive ingredients in Zulresso.

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

You should not take Zulresso if:you have kidney disease; oryou have a known allergy to brexanolone or other active and inactive ingredients in Zulresso.

You should not take Zulresso if:

Zulresso Uses

Research shows that as of 2012, about 11% of women in the United States were living with postpartum depression.

Postpartum depression is a mental condition that occurs after childbirth. It causes a person who has it to experience recurring feelings of sadness and emptiness that can interfere with their daily lives and parenting.

In a 2019 study on the effectiveness and safety of Zulresso, researchers found that, when Zulresso was administered as an infusion over 60 hours to participants with moderate or severe postpartum depression, they experienced a significant reduction in depression scores as compared to those who were given a placebo.

Before Taking Zulresso

You can only access Zulresso through a program called Zulresso Risk Evaluation and Mitigation Strategy (Zulresso REMS). You must register for the program before this medication can be administered to you. This is because of the risk of excessive sedation and loss of consciousness associated with using this medication.

Healthcare facilities that wish to administer Zulresso are also required to enroll in the program and ensure that patients to which Zulresso is administered are also enrolled in the program.

Patients with renal diseases, especially end-stage renal disease should avoid using Zulresso.

According to the manufacturer, no contraindications with other medication have been reported while using Zulresso.

Nevertheless, it is important to disclose to your doctor any other medication, vitamins, and supplements you are using before taking Zulresso or any other new medication.

Allergic ReactionsIn rare cases, some people might experience an allergic reaction when using Zulresso. Symptoms of an allergic reaction include a rash or hives, difficulty breathing, swelling of the throat, tongue, or face.

Allergic Reactions

In rare cases, some people might experience an allergic reaction when using Zulresso. Symptoms of an allergic reaction include a rash or hives, difficulty breathing, swelling of the throat, tongue, or face.

Zulresso Dosage

A pulse oximeter is used to check your pulse during the period of infusion to monitor for hypoxia—a condition in which the tissues in your body become deprived of adequate oxygen.

Here is how the dosage is broken down over the 60-hour period

Modifications

One of the side effects you might experience while using Zulresso is excessive sedation. If your doctor notices you are excessively sedated at any point during the infusion they might pause the medication until your symptoms pass. When the infusion is resumed they might lower the dosage.

How to Take and Store

Zulresso is supplied as a concentrated solution in vials to certified healthcare facilities in the Zulresso REM program. This solution is required to be diluted before being administered to patients.

After it has been diluted, the medication is transferred to infusion bags and can be stored in refrigerated rooms for up to 96 hours. If stored at room temperature, the medication will only be viable for 12 hours. The medication is administered through an intravenous tube and must not be combined with any other medication in the same infusion bag.

An unopened vial of the concentrated solution can be stored at room temperature away from direct sunlight. A diluted bag can either be refrigerated or stored at room temperature, albeit for a shorter period than if refrigerated.

Before administration, the vial should be closely inspected. If there are any signs of discoloration or the presence of any other matter in it, then it should be carefully disposed of. Five infusion bags are typically prepared for the 60-hour period it takes to administer the medication.

Side Effects of Zulresso

Zulresso has been linked to some side effects in women. While some are mild and tend to dissipate with time, others can be more severe and could call for discontinuation of the medication.

Common

Some common side effects you might experience when using Zulresso include:

Severe

In rare cases, some people might experience more severe side effects while using Zulresso. Some include:

When using Zulresso, you might experience excessive sedation or sudden loss of consciousness during infusion. There is also an increased risk of experiencing suicidal thoughts when using Zulresso.

If you or someone you know is receiving Zulresso, look out for changes in moods and behaviors. Tell your healthcare provider immediately if you notice any of these symptoms.

If you are having suicidal thoughts, contact theNational Suicide Prevention Lifelineat988for support and assistance from a trained counselor. If you or a loved one are in immediate danger, call 911.For more mental health resources, see ourNational Helpline Database.

If you are having suicidal thoughts, contact theNational Suicide Prevention Lifelineat988for support and assistance from a trained counselor. If you or a loved one are in immediate danger, call 911.

For more mental health resources, see ourNational Helpline Database.

If Zulresso is administered alongside depressants such as opioids andbenzodiazepines, you might experience an increase in the likelihood of adverse reactions like excessive sedation.

The active ingredient in Zulresso is brexanolone which is aschedule IV controlled substance. This means that it has the potential to be abused or for a dependency on the medication to develop.

7 SourcesVerywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Ko JY.Trends in Postpartum Depressive Symptoms— 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66.Leader LD, O’Connell M, VandenBerg A.Brexanolone for postpartum depression: clinical evidence and practical considerations.Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 2019;39(11):1105-1112.U.S. Food and Drug Administration.FDA approves first treatment for post-partum depression.Azhar Y, Din AU.Brexanolone. In: StatPearls. StatPearls Publishing; 2020.Michigan Medicine, University of Michigan.Brexanolone. January 8, 2020Dacarett-Galeano DJ, Diao XY.Brexanolone: a novel therapeutic in the treatment of postpartum depression.American Journal of Psychiatry Residents’ Journal. 2019;15(2):2-4. doi:10.1177/0897190020979627U.S. National Library of Medicine.Zulresso- brexanolone injection, solution. December 14, 2020

7 Sources

Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Ko JY.Trends in Postpartum Depressive Symptoms— 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66.Leader LD, O’Connell M, VandenBerg A.Brexanolone for postpartum depression: clinical evidence and practical considerations.Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 2019;39(11):1105-1112.U.S. Food and Drug Administration.FDA approves first treatment for post-partum depression.Azhar Y, Din AU.Brexanolone. In: StatPearls. StatPearls Publishing; 2020.Michigan Medicine, University of Michigan.Brexanolone. January 8, 2020Dacarett-Galeano DJ, Diao XY.Brexanolone: a novel therapeutic in the treatment of postpartum depression.American Journal of Psychiatry Residents’ Journal. 2019;15(2):2-4. doi:10.1177/0897190020979627U.S. National Library of Medicine.Zulresso- brexanolone injection, solution. December 14, 2020

Verywell Mind uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Ko JY.Trends in Postpartum Depressive Symptoms— 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66.Leader LD, O’Connell M, VandenBerg A.Brexanolone for postpartum depression: clinical evidence and practical considerations.Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 2019;39(11):1105-1112.U.S. Food and Drug Administration.FDA approves first treatment for post-partum depression.Azhar Y, Din AU.Brexanolone. In: StatPearls. StatPearls Publishing; 2020.Michigan Medicine, University of Michigan.Brexanolone. January 8, 2020Dacarett-Galeano DJ, Diao XY.Brexanolone: a novel therapeutic in the treatment of postpartum depression.American Journal of Psychiatry Residents’ Journal. 2019;15(2):2-4. doi:10.1177/0897190020979627U.S. National Library of Medicine.Zulresso- brexanolone injection, solution. December 14, 2020

Ko JY.Trends in Postpartum Depressive Symptoms— 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66.

Leader LD, O’Connell M, VandenBerg A.Brexanolone for postpartum depression: clinical evidence and practical considerations.Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. 2019;39(11):1105-1112.

U.S. Food and Drug Administration.FDA approves first treatment for post-partum depression.

Azhar Y, Din AU.Brexanolone. In: StatPearls. StatPearls Publishing; 2020.

Michigan Medicine, University of Michigan.Brexanolone. January 8, 2020

Dacarett-Galeano DJ, Diao XY.Brexanolone: a novel therapeutic in the treatment of postpartum depression.American Journal of Psychiatry Residents’ Journal. 2019;15(2):2-4. doi:10.1177/0897190020979627

U.S. National Library of Medicine.Zulresso- brexanolone injection, solution. December 14, 2020

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