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.

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. 

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.

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.

If you forget to taking your dose, skip the missed dose and take the next dose at your regular time the next evening. Do not take extra capsules to make up for the missed dose. Continue taking Zuranolone once daily until you complete the rest of your treatment course. 

If you take too much Zuranolone, it is very important to call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away. 

You should not drive a car, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose of this medicine, as Zuranolone may make you feel sleepy, confused, or dizzy.

You should not drink alcohol or take other medicines that make you sleepy or dizzy while taking this medicine without talking to your healthcare provider.