Zuranolone

Generic name: Zuranolone
Brand names: Zurzuvae
Dosage form: capsules (20mg, 25mg, 30 mg)

Usage of Zuranolone

Zuranolone capsules are used for the treatment postpartum depression (PPD), it is a rapid-acting, once-daily capsule taken for 14 days. Zuranolone works quickly to improve depression symptoms, starting in 3 days compared to current treatment options, which may take weeks or months to work. Zuranolone is the first oral medication to be approved by the FDA to treat postpartum depression.

Zurzuvae is the brand name for zuranolone. During development, it was called SAGE-217 and BIIB125.

Postpartum depression is a major depressive episode that can occur after childbirth but can also start during the later stages of pregnancy. PPD is a serious condition in which women may feel intense anxiety, sadness, shame, guilt, problems sleeping, stress, panic attacks, and suicidal thoughts or attempts. This can make it difficult for mothers to care for and bond with their babies and may delay the child's physical and emotional development.

Is Zuranolone FDA approved?

Yes, under the brand name Zurzuvae, FDA approval was granted for Zurzuvae to treat adults with postpartum depression on August 04, 2023. Approval was granted to Sage Therapeutics, Inc. The application for FDA approval was supported by the LANDSCAPE and NEST clinical trials.

Zuranolone side effects

Zuranolone may cause serious side effects, including:

Increased risk of suicidal thoughts or actions. Zuranolone, along with other antidepressant medications, may increase the risk of suicidal thoughts and actions in people that are 24 years of age and younger. This medicine should only be used in adults. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

It is important to watch for and try to prevent suicidal thoughts and actions.

Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.

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, especially if they are new, worse, or worry you: attempts to commit suicide, panic attacks, thoughts about suicide or dying, new or worse irritability, new or worse depression, acting aggressive or being angry or violent, feeling very agitated or restless, an extreme increase in activity and talking, trouble sleeping, acting on dangerous impulses, new or worse anxiety, other unusual changes in behavior or mood.

Common Zuranolone side effects may include:

Sleepiness or drowsiness

Tiredness

Dizziness

Common cold

Diarrhea

Urinary tract infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Zuranolone

Tell your healthcare provider about all of your medical conditions, including if you:

drink alcohol

have abused or been dependent on prescription medicines, street drugs, or alcohol

have kidney or liver problems.

Pregnancy

Tell your health care provider if you are pregnant or plan to become pregnant, as this medicine may harm your unborn baby. If you are able to become pregnant, then while taking this medicine and for one week afterward you should use effective contraception.

You should tell your healthcare provider right away if you become pregnant while on Zuranolone.

There is a pregnancy registry for females who are take Zuranolone during their pregnancy. The purpose of the registry is to collect information about the health of females exposed to this medicine and their baby. If you become pregnant during treatment with this medicine, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ .

Breastfeeding

Zuranolone passes into breast milk, and it is not known if it can harm your baby. Talk to your healthcare provider about the risks and benefits of breastfeeding and about the best way to feed your baby during treatment with this medicine.

How to use Zuranolone

Zuranolone is taken once a day in the evening, with fatty food, for 14 days (two weeks).

Dose: 50 mg evening. Duration: 14 days. Comments: Patients unable to tolerate 50 mg once daily may have dose reduced to 40 mg. This medicine can be used as a single therapy or together with other oral antidepressant medications. Zurzuvae is available as 20mg, 25mg and 30mg capsules.

Warnings

Decreased ability to drive or do other dangerous activities.

Zuranolone may decrease your awareness and alertness, which can affect your ability to drive safely or operate machinery, or do other dangerous activities. Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each capsule during your 14-day treatment with this medicine. You may not be able to tell on your own how much this medicine is affecting or whether you can drive safely.

Decreased awareness and alertness

Zuranolone may cause sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking therefore, you may be at a higher risk for falls while taking this medicine. Drinking alcohol, other medicines that cause CNS depressant effects, or opioids while taking this medicine can make these symptoms worse and may also cause trouble breathing.

Tell your healthcare provider if you develop any of these symptoms or if they get worse during treatment with this medicine.

Your healthcare provider may lower your dose or stop treatment if you develop these symptoms.

What other drugs will affect Zuranolone

Drugs may interact with Zuranolone, this includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

It is especially important to tell your healthcare provider if you take:

antidepressants

opioids

CNS depressants such as benzodiazepines.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.