Zuranolone (zoo-RAN-oh-lone)

Treats postpartum depression (PPD).

Brand Name(s):

Zurzuvae

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine together with fat-containing food.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose or forget to take your medicine, skip the missed dose and take your next regular dose. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how zuranolone works. Tell your doctor if you are using itraconazole, rifampin, benzodiazepine medicine (including alprazolam), or other medicine to treat depression (including TCAs).
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, or a history of depression or drug or alcohol abuse.
• This medicine may increase risk of thoughts or behavior of suicide.
• This medicine may make you less alert and aware, which can affect your ability to drive and do other dangerous activities safely. Do not drive or do anything that could be dangerous for at least 12 hours after taking each dose.
• This medicine may cause confusion, dizziness, drowsiness, sleepiness, slow thinking, or trouble with walking, which may lead to falls.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine, change in how much or how often you urinate
• Dizziness, drowsiness or sleepiness, loss of consciousness
• Fever, chills, cough, sore throat, body aches
• Thoughts or attempts of killing yourself, changes in mood or behavior

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088