Armodafinil ARTVIGIL (Nuvigil) US$ 1.30 ea

What is the most important information I should know about armodafinil?

You should not use this medicine if you have ever had a rash or allergic reaction caused by armodafinil or modafinil (Provigil).

Stop taking armodafinil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to armodafinil has caused severe skin reactions serious enough to require hospitalization. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, and a red or purple skin rash that spreads and causes blistering and peeling.

What is armodafinil?

Armodafinil is a medication that promotes wakefulness.

Armodafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.

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

What should I discuss with my health care provider before taking armodafinil?

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have:

• liver or kidney disease;
• a heart muscle or valve disorder such as mitral valve prolapse;
• heart disease or history of heart attack;
• high blood pressure;
• a history of mental illness or psychosis; or
• a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Armodafinil can make certain types of birth control less effective for as long as a month after you stop taking armodafinil. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking armodafinil.

It is not known whether armodafinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 17 years old without medical advice.

How should I take armodafinil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction. Selling or giving away armodafinil is against the law.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor's instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.

Talk with your doctor about what to do if you miss a dose of armodafinil. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, diarrhea, confusion, feeling restless or excited, fast or slow heart rate, chest pain, trouble sleeping, or hallucinations (seeing or hearing things that are not real).

What should I avoid while taking armodafinil?

Armodafinil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.

Avoid drinking alcohol while taking armodafinil.

What are the possible side effects of armodafinil?

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

Stop taking armodafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.

Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to armodafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.

Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;
• unusual bleeding (nosebleeds, bleeding gums);
• mouth sores, trouble swallowing;
• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts;
• chest pain, uneven heart beats; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• headache, dizziness;
• nausea;
• 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.

What other drugs will affect armodafinil?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking armodafinil with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about armodafinil.