Zuranolone

Zuranolone may decrease your awareness and alertness and may cause drowsiness, sleepiness, dizziness, confusion, or trouble walking. This may increase the risk of falls during your treatment with zuranolone. Call your doctor if you develop any of these symptoms or if they get worse during your treatment: drowsiness, sleepiness, dizziness, confusion, or trouble walking.

Do not drive a car, operate machinery, or participate in potentially dangerous activities until at least 12 hours after taking each dose of zuranolone. You may not be able to tell on your own if you can drive safely or how much zuranolone is affecting you.

Tell your doctor if you drink or have ever drunk large amounts of alcohol. Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or taking certain other medications during your treatment with zuranolone increases the risk that you will experience these serious side effects. Do not drink alcohol or take prescription or nonprescription medications that contain alcohol or make you sleepy or dizzy during your treatment without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with zuranolone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's websit} to obtain the Medication Guide.

Zuranolone is used for the treatment of postpartum depression (PPD) (depression that occurs after giving birth) in adult women. Zuranolone is in a class of medications called neurosteroid antidepressants. It works by changing the activity of certain natural substances in the brain.

Zuranolone comes as a capsule to take by mouth. It is usually taken with a fat-containing food (400 to 1000 calories) once a day in the evening for 14 days. Take zuranolone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take zuranolone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Zuranolone may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking zuranolone,

• tell your doctor and pharmacist if you are allergic to zuranolone, any other medications, or any of the ingredients in zuranolone capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with zuranolone: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking zuranolone. Do not start any of these medications while taking zuranolone without discussing with your healthcare provider.
• tell your doctor if you use or have ever used street drugs or have overused prescription medications. or if you have or have ever had kidney or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use effective birth control during your treatment with zuranolone and for 1 weeks after your final dose. If you become pregnant while taking zuranolone, call your doctor immediately. If it is unknown if zuranolone has an effect on the infant if exposed through breastfeeding. Talk to your doctor about risks and benefits of continuing to breastfeed while receiving zuranolone.
• you should know that your mental health may change in unexpected ways when you take zuranolone or other antidepressantsin patients aged 24 years or younger. You may become suicidal, especially at the beginning of your treatment and any time that your dose is changed. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Zuranolone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• dry mouth
• nasal congestion, runny nose, sneezing, or sore throat
• weakness
• lack of energy
• muscle pain or twitching
• toothache

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING or the SPECIAL PRECAUTIONS sections, call your doctor immediately.

Zuranolone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• extreme drowsiness or sleepiness
• decreased or loss of consciousness

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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