Zurzuvae

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

Usage of Zurzuvae

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

Zurzuvae is the brand name for zuranolone, and 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.

Zurzuvae side effects

Common Zurzuvae side effects may include:

Sleepiness or drowsiness

Tiredness

Dizziness

Common cold

Diarrhea

Urinary tract infection.

Zurzuvae may cause serious side effects, including

Increased risk of suicidal thoughts or actions. Zurzuvae, along with other antidepressant medicines, may increase the risk of suicidal thoughts and actions in people that are 24 years of age and younger. This medicine is not for use in children. 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.

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 Zurzuvae

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 Zurzuvae.

There is a pregnancy registry for females who are take Zurzuvae 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 Zurzuvae, 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

Zurzuvae 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.

How to use Zurzuvae

Zurzuvae 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.

Zurzuvae may decrease your awareness and alertness, which can affect your ability to drive safely or operate machinery, or do other dangerous activities. You should 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 if you can drive safely or tell how much this medicine is affecting you.

Decreased awareness and alertness

Zurzuvae 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 Zurzuvae

Many drugs can interact with Zurzuvae. 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

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