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.

You should not use armodafinil 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. Other signs of a severe reaction include fever, swelling in your face or tongue, mouth sores, trouble breathing, swelling in your legs, yellowing of your skin or eyes, and skin rash or blistering sores.

Follow all directions on your prescription label. Do not take armodafinil 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.

Read all patient information, medication guides, and instruction sheets provided to you. 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.

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. 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.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Usual Adult Dose for Narcolepsy:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day.
-This drug is not a treatment for the underlying obstruction in OSA.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Uses: To improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

150 to 250 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day.
-This drug is not a treatment for the underlying obstruction in OSA.
-In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Uses: To improve wakefulness in patients with excessive sleepiness associated with OSA and narcolepsy.

Usual Adult Dose for Shift Work Sleep Disorder:

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: To improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

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 ever had:

• liver or kidney disease;

• a heart muscle or valve disorder such as mitral valve prolapse;

• high blood pressure, heart disease, or prior heart attack;

• mental illness or psychosis; or

• drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

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

Armodafinil is not approved for use by anyone younger than 17 years old.

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.

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).

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).

Store armodafinil in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

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

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

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.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

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

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

Armodafinil may cause serious side effects. Stop using armodafinil and call your doctor at once if you have:

• bruising, severe tingling, numbness, pain, muscle weakness;

• unusual bleeding (nosebleeds, bleeding gums);

• skin sores or blistering;

• mouth sores, trouble swallowing;

• chest pain, uneven heart beats; or

• depression, anxiety, hallucinations, aggression, unusual thoughts or behavior, suicidal thoughts.

Common side effects of armodafinil may include:

• headache, dizziness;

• nausea; 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.

Taking armodafinil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Selling or giving away armodafinil is against the law. 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.