What is modafinil?
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 other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking modafinil?
You should not use this medication if you are allergic to modafinil or armodafanil (Nuvigil).
If you have any of these other conditions, you may need a dose adjustment or special tests to
safely take modafanil:
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angina (chest pain);
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cirrhosis or other liver problem;
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kidney disease;
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a heart muscle or valve disorder such as mitral valve
prolapse;
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a history of drug addiction;
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if you take blood pressure medications; or
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if you have recently had a heart attack.
Skin rashes serious enough to require hospitalization have occurred in
people using a medicine similar to modafinil. These rashes usually occurred within 1 to 5 weeks after
the first dose.
Stop taking modafinil and call your doctor at the first sign of any skin rash, no matter how
minor you think it might be.
FDA pregnancy category C. It is not known whether modafanil is harmful to an unborn
baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant
during treatment.
Modafinil can make certain types of birth control pills less effective, which could result in an
unplanned pregnancy. 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.
Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not give modafinil to anyone younger than 16 years old.
How should I take modafinil?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or
for longer than recommended. Modafinil is usually given for 12 weeks or less. Follow the directions
on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these
directions carefully. Ask your doctor or pharmacist if you have any questions.
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.
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.
Talk with your doctor if you continue to have excessive sleepiness even while taking modafinil.
Taking this medication does not take the place of getting enough sleep.
Store modafinil at room temperature away from moisture and heat.
What happens if I miss a dose of modafinil?
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 modafinil.
Do not
take extra medicine to make up the missed dose.
Where can I get more information about modafinil?
Your pharmacist has information about modafinil written for health professionals that you may read.
What are the possible side effects of modafinil?
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 using modafinil and call your doctor at once if you have any of these serious side
effects:
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fever, sore throat, headache, and vomiting with a severe blistering,
peeling, and red skin rash;
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bruising, severe tingling, numbness, pain, muscle weakness;
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easy bruising or bleeding;
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white patches or sores inside your mouth or on your lips;
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hallucinations, unusual thoughts or behavior;
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depression, anxiety; or
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chest pain, uneven heart beats.
Less serious side effects may include:
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 is the most important information I should know about modafinil?
You should not use this medication if you are allergic to modafinil or armodafanil (Nuvigil).
Before using modafinil, tell your doctor if you have angina (chest pain), liver or kidney disease, a
heart problem, a history of drug addiction, if you take blood pressure medication, or if you have
recently had a heart attack.
Modafinil affects the central nervous system. This can cause effects that 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.
Stop taking modafinil and call your doctor if you have a skin rash, no matter how mild. A
medicine similar to modafinil has caused severe skin reactions serious enough to require hospitalization.
Other signs of a severe reaction include fever, sore throat, headache, and vomiting with a severe
blistering, peeling, and red skin rash.
There may be other drugs that can interact with modafinil. Tell your doctor about all your
prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs
prescribed by other doctors. Do not start a new medication without telling your doctor.
What should I avoid while taking modafinil?
Modafinil affects the central nervous system. This can cause effects that 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 modafinil.
What other drugs will affect modafinil?
Before using modafinil, tell your doctor if you are using any of the following drugs:
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cyclosporine (Neoral, Sandimmune, Gengraf);
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propranolol (Inderal);
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rifampin (Rifadin, Rimactane, Rifater);
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a sedative such as diazepam (Valium), midazolam (Versed),
or triazolam (Halcion);
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antifungal medications such as itraconazole (Sporanox) or
ketoconazole (Nizoral);
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seizure medication such as carbamazepine (Carbatrol,
Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton);
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antidepressants such as amitriptyline (Elavil, Etrafon),
doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or
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an MAO inhibitor such as isocarboxazid (Marplan),
phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine
(Parnate).
This list is not complete and there may be other drugs that can interact with
modafinil. Tell your doctor about all your prescription and over-the-counter medications, vitamins,
minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication
without telling your doctor.
What happens if I have an overdose of modafinil?