Modafinil (patient information)

Why is this medication prescribed

Modafinil is used to treat excessive sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) or shift work sleep disorder (sleepiness during scheduled waking hours and difficulty falling asleep or staying asleep during scheduled sleeping hours in people who work at night or on rotating shifts). Modafinil is also used along with breathing devices or other treatments to prevent excessive sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep and therefore doesn't get enough restful sleep). Modafinil is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.

How should this medicine be used

Modafinil comes as a tablet to take by mouth. It is usually taken once a day with or without food. If you are taking modafinil to treat narcolepsy or OSAHS, you will probably take it in the morning. If you are taking modafinil to treat shift work sleep disorder, you will probably take it 1 hour before the beginning of your work shift. Take modafinil at the same time every day. Do not change the time of day that you take modafinil without talking to your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take modafinil exactly as directed.

Modafinil may be habit forming. Do not take more or less of it or take it more often than prescribed by your doctor. If you take more than your prescribed dose, you may find it harder to fall asleep and stay asleep.

Modafinil may decrease your sleepiness, but it will not cure your sleep disorder. Continue to take modafinil even if you feel well. Do not stop taking modafinil without talking to your doctor.

Modafinil should not be used in place of getting enough sleep. Follow your doctor's advice about good sleep habits. Continue to use any breathing devices or other treatments that your doctor has prescribed to treat your condition, especially if you have OSAHS.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking modafinil

• tell your doctor and pharmacist if you are allergic to modafinil or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); certain antidepressants such as clomipramine (Anafranil) and desipramine (Norpramin); certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); cyclosporine (Neoral, Sandimmune); cyclophosphamide (Cytoxan, Neosar); diazepam (Valium); certain medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate); primidone (Mysoline);propranolol (Inderal); certain proton pump inhibitors such as lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole (Protonix); selective serotonin reuptake inhibitors (SSRIs) such as as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); rifampin (Rifadin, Rimactane); and triazolam (Halcion). Many other medications may also interact with modafinil, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you drink large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications, especially stimulants. Also tell your doctor if you have ever had chest pain, an irregular heartbeat, or other heart problems after taking a stimulant, and if you have or have ever had high blood pressure, a heart attack, angina (chest pain), mental illness, or heart, liver, or kidney disease.
• you should know that modafinil may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, injections, and intrauterine devices). Use another form of birth control while taking modafinil and for 1 month after you stop taking it. Talk to your doctor about types of birth control that will work for you while you are taking modafinil.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking modafinil, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking modafinil.
• you should know that modafinil may affect judgment or thinking and may not completely relieve the sleepiness caused by your disorder. Do not drive a car or operate machinery until you know how this medication affects you. If you avoided driving and *other dangerous activities because of your sleep disorder, do not start performing these activities again without talking to your doctor even if you feel more alert.
• be aware that you should avoid drinking alcohol while taking modafinil.

What special dietary instructions should I follow

Talk to your doctor about eating grapefruit or drinking grapefruit juice while you are taking this medication.

What should I do if I forget a dose

You should skip the missed dose. Wait until the next time you are supposed to take modafinil, and then take your normal dose. If you take modafanil too late in your waking day, you may find it harder to go to sleep. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

Modafinil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nervousness
• anxiety or restlessness
• dizziness
• difficulty falling asleep or staying asleep
• drowsiness
• depression
• mood swings
• upset stomach
• diarrhea
• constipation
• gas
• heartburn
• loss of appetite
• ulcers in the mouth
• unusual tastes
• sweating
• dry mouth
• excessive thirst
• runny nose
• nosebleed
• flushing
• tight muscles or difficulty moving
• back pain
• confusion
• shaking of a part of your body that you cannot control
• burning, tingling, or a numbness of the skin
• difficulty seeing or eye pain
• flu like symptoms

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• chest pain
• changes in mental health
• fast, pounding, or irregular heartbeat
• blood in the urine
• fever, sore throat, chills, and other signs of infection
• rash
• hives
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

Some children who took modafinil had a decrease in the number of their white blood cells (a type of blood cell that fights infection). Modafinil has not been shown to be safe for children under age 16. Talk to your child's doctor about the risks of giving modafinil to your child.

Modafinil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

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.Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• difficulty falling asleep or staying asleep
• agitation
• restlessness
• confusion
• hallucinations (seeing things or hearing voices that do not exist)
• nervousness
• shaking of a part of your body that you cannot control
• fast, slow or pounding heartbeat
• chest pain
• upset stomach
• diarrhea

What other information should I know

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Provigil®