Modafinil

What is modafinil used for?

• Modafinil is used to treat a lot of sleepiness that may happen with sleep apnea, narcolepsy, or shift work problems.
• Modafinil may be given to you for other reasons. Talk to your doctor.

Before taking modafinil, tell your doctor:

• If you are allergic to modafinil; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had a rash when taking modafinil or a drug like it.
• If you have heart problems.
• If you have heart valve problems.

This is not a list of all drugs or health problems that interact with modafinil.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take modafinil with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take modafinil?

• Tell all of your health care providers that you take modafinil. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine is not a cure for sleep problems and does not replace sleep. Stay under the care of your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how modafinil affects you. You may also need to avoid doing these things if you do not feel awake enough after taking modafinil. If you still feel sleepy after taking modafinil, talk with your doctor.
• This medicine may be habit-forming with long-term use.
• Check blood pressure and heart rate as the doctor has told you.
• You may need to have some heart tests before starting modafinil. If you have questions, talk with your doctor.
• Avoid drinking alcohol while taking modafinil.
• Mental or mood problems like depression and suicidal thoughts have happened with modafinil. Sometimes, people needed to get treated in a hospital. If you have ever had any mental or mood problems, talk with your doctor.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with modafinil may cause nervousness, shakiness, and a fast heartbeat.
• If you are 65 or older, use modafinil with care. You could have more side effects.
• This medicine is not approved for use in children. The chance of very bad and sometimes deadly skin reactions like Stevens-Johnson syndrome may be raised in children. However, your child's doctor may decide the benefits of taking modafinil may outweigh the risks. Talk with the doctor if you have questions about giving modafinil to your child.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also, like a condom, when taking modafinil and for 1 month after the last dose.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is modafinil best taken?

Use modafinil as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• If taken with food, modafinil may take longer to work.
• Shift work sleep problem: Take 1 hour before the start of work.
• Narcolepsy and sleep apnea: Take modafinil in the morning.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is near bedtime, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of modafinil that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Signs of heart problems like chest pain, fast heartbeat, a heartbeat that does not feel normal, or shortness of breath.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Hallucinations (seeing or hearing things that are not there).
• Change in how you act.
• Feeling confused.
• Swollen gland.
• Fever or chills.
• Sore throat.
• Swelling in the arms or legs.
• Dark urine or yellow skin or eyes.
• Not able to pass urine or change in how much urine is passed.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Muscle or joint pain.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of modafinil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Headache.
• Diarrhea.
• Trouble sleeping.
• Back pain.
• Dizziness.
• Upset stomach.
• Runny nose.
• Stuffy nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out modafinil?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time modafinil is refilled. If you have any questions about modafinil, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take modafinil or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to modafinil. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.