Vilazodone is an antidepressant that is used to treat major depressive disorder (MDD).

Vilazodone may also be used for purposes not listed in this medication guide.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Vilazodone is not approved for use by anyone younger than 18 years old.

Do not stop using vilazodone without first asking your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take with food.

Your symptoms may not improve for up to several weeks.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using vilazodone suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Depression:

Initial dose: 10 mg orally once a day for 7 days, followed by 20 mg orally once a day for an additional 7 days
Maintenance dose: 40 mg orally once a day

Comment: This drug should be taken with food.

Use: Treatment of major depressive disorder (MDD)

Do not use vilazodone if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

After you stop taking vilazodone, you must wait at least 14 days before you start taking an MAOI.

Tell your doctor if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with vilazodone could cause a serious condition called serotonin syndrome.

Tell your doctor if you have ever had:

• liver or kidney disease;

• a bleeding or blood clotting disorder;

• narrow-angle glaucoma;

• seizures or epilepsy;

• bipolar disorder (manic depression);

• sexual problems;

• drug addiction or suicidal thoughts; or

• if you drink alcohol.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking vilazodone during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop vilazodone without asking your doctor.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vilazodone on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vilazodone can be fatal.

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).

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.

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

Unless your doctor tells you otherwise, continue your normal diet.

Drinking alcohol with vilazodone can cause side effects.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with vilazodone may cause you to bruise or bleed easily.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Vilazodone may cause serious side effects. Call your doctor at once if you have:

• a seizure (convulsions);

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• easy bruising, unusual bleeding;

• racing thoughts, unusual risk-taking behavior, decreased inhibitions, feelings of extreme happiness or sadness; or

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects of vilazodone may include:

• nausea, vomiting;

• diarrhea; or

• sleep problems (insomnia).

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.

Using vilazodone with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can affect vilazodone, especially:

• any other antidepressants;

• mephenytoin;

• St. John's wort;

• tramadol;

• a diuretic or "water pill";

• medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia;

• a blood thinner--warfarin, Coumadin, Jantoven; or

• migraine headache medicine--sumatriptan, Imitrex, Maxalt, Treximet, and others.

This list is not complete and many other drugs may affect vilazodone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.