ZURZUVAE is a medication that contains the active ingredient zuranolone, which is a neuroactive steroid and gamma-aminobutyric acid (GABA) A receptor positive modulator. It is formulated as capsules available in 20 mg, 25 mg, and 30 mg strengths intended for oral administration. Key inactive ingredients in the capsules include colloidal silicon dioxide, croscarmellose sodium, and mannitol.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every evening. Take it with fat-containing food. Talk to your care team about examples of foods you should eat. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake -Thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Diarrhea -Dizziness -Drowsiness -Fatigue

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Frequently drink alcohol -Kidney disease -Liver disease -Suicidal thoughts, plans, or attempt -An unusual or allergic reaction to zuranolone, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Alcohol -Benzodiazepines, such as alprazolam, diazepam, lorazepam -Certain antihistamines -Certain medications for depression, such as amitriptyline or trazodone -Certain medications for seizures, such as phenobarbital or primidone -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Opioids for pain or cough -Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery for at least 12 hours after taking each dose. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of side effects. This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. Call your care team right away if you experience these thoughts or worsening depression. Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 week after the last dose. Contraception is recommended while taking this medication and for 1 week after the last dose. Your care team can help you find the option that works for you. Discuss this medication with your care team before breastfeeding. There are benefits and risks to taking medications while breastfeeding. Your care team can help you find the option that works for you.

What are the most serious risks of this medication?

This medication may cause drowsiness, dizziness, loss of coordination, and slow thinking. Do not drive or take part in tasks that require you to be aware and alert for at least 12 hours after you take a dose. You may not be able to tell on your own how this drug affects you.