You should not use this medication if you are allergic to modafinil or armodafanil (Nuvigil).
Before using modafinil, tell your doctor if you are allergic to any drugs, or if you have:
- angina (chest pain);
- cirrhosis or other liver problem;
- kidney disease;
- a heart muscle or valve disorder such as mitral valve prolapse;
- a history of drug addiction;
- if you take blood pressure medications; or
- if you have recently had a heart attack.
If you have any of these conditions, you may not be able to use modafinil, or you may need dosage adjustments or special tests during treatment.
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. This medication may be harmful to an unborn baby. 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.
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.
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include feeling excited or agitated, confusion, trouble sleeping, nausea, or diarrhea.
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.
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:
- fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
- bruising, severe tingling, numbness, pain, muscle weakness;
- easy bruising or bleeding;
- white patches or sores inside your mouth or on your lips;
- hallucinations, unusual thoughts or behavior;
- depression, anxiety; or
- chest pain, uneven heart beats.
Less serious side effects may include:
- headache, dizziness;
- feeling nervous or agitated;
- nausea, diarrhea;
- trouble sleeping (insomnia); or
- dry mouth.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Before using modafinil, tell your doctor if you are using any of the following drugs:
- cyclosporine (Neoral, Sandimmune, Gengraf);
- propranolol (Inderal);
- rifampin (Rifadin, Rimactane, Rifater);
- a sedative such as diazepam (Valium), midazolam (Versed), or triazolam (Halcion);
- antifungal antibiotics such as itraconazole (Sporanox) or ketoconazole (Nizoral);
- seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton);
- antidepressants such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or
- 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.
Provigil and modafinil
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04