Modafinil is a medication that promotes wakefulness.

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

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

You should not use this medicine if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).

Modafinil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have a skin rash or hives, blisters or peeling, mouth sores, trouble breathing or swallowing, fever, swelling in your legs, dark urine, yellowing of your skin or eyes, or swelling in your face.

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

Modafinil may be habit-forming. Never share modafinil with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away modafinil is against the law.

Modafinil 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.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

You may take modafinil with or without food.

Modafinil is usually given for 12 weeks or less.

If you are taking modafinil 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 a 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 modafinil may be necessary to best treat your condition.

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

Call your doctor if you continue to have excessive sleepiness even while taking modafinil.

Taking modafinil does not take the place of getting enough sleep.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Modafinil 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:

200 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), this drug is not a treatment for the underlying obstruction.
-If 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 and during treatment with this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with narcolepsy and OSA.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

200 mg orally once a day in the morning

Comments:
-In obstructive sleep apnea (OSA), this drug is not a treatment for the underlying obstruction.
-If 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 and during treatment with this drug.

Use: Treatment to improve wakefulness in patients with excessive sleepiness associated with narcolepsy and OSA.

Usual Adult Dose for Shift Work Sleep Disorder:

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

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

You should not use modafinil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).

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

• angina (chest pain);

• cirrhosis or other liver problem;

• kidney disease;

• high blood pressure, heart disease, or history of heart attack;

• a history of mental illness or psychosis; or

• history of alcoholism or drug addiction.

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

Modafinil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Talk with your doctor about the best methods of birth control to use while taking modafinil.

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

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

Talk with your doctor about what to do if you miss a dose of modafinil. Avoid taking the medicine if you do not plan to be awake for several hours. Skip the missed dose if it is almost bedtime. 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.

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 modafinil 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 or drinking grapefruit juice while you are taking this medication.

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

Avoid other dangerous activities until you know how modafinil will affect your level of wakefulness.

Avoid drinking alcohol while taking modafinil.

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

Modafinil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking modafinil and get emergency medical help if you have:

• skin rash or hives, blisters or peeling;

• mouth sores, trouble swallowing;

• fever, shortness of breath;

• swelling in your legs;

• dark urine, jaundice (yellowing of the skin or eyes); or

• swelling in your face, eyes, lips, tongue, or throat.

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

• depression, anxiety, suicidal thoughts or actions;

• hallucinations, unusual thoughts or behavior, aggression, being more active or talkative than usual;

• chest pain, trouble breathing, uneven heart beats; or

• the first sign of any skin rash, no matter how minor you think it might be.

Common side effects of modafinil may include:

• headache, dizziness;

• feeling nervous or anxious;

• back pain;

• nausea, diarrhea, upset stomach;

• sleep problems (insomnia); or

• stuffy nose.

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.

Other drugs may interact with modafinil, 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 modafinil 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.