Pronunciation:

moe-DAF-i-nil

Brand Names:

• Provigil

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Amphetamine Related

Uses of This Medicine:

Modafinil is used to help people who have narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), or shift work sleep disorder (SWSD) to stay awake during the day. Modafinil does not cure these conditions and will only work as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of modafinil in children younger than 17 years of age. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of modafinil have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of modafinil in the elderly. However, elderly patients may have a slower removal of this medicine from the body, which may require an adjustment in the dose for patients receiving modafinil.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Mavacamten

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Amiodarone
• Amphetamine
• Atogepant
• Avacopan
• Avapritinib
• Axitinib
• Benzhydrocodone
• Brigatinib
• Buprenorphine
• Capivasertib
• Capmatinib
• Citalopram
• Clarithromycin
• Clobazam
• Cobimetinib
• Codeine
• Cyclosporine
• Daclatasvir
• Daridorexant
• Darunavir
• Deflazacort
• Desogestrel
• Dextroamphetamine
• Dienogest
• Dihydrocodeine
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Drospirenone
• Duvelisib
• Elacestrant
• Elbasvir
• Encorafenib
• Entrectinib
• Enzalutamide
• Erdafitinib
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fedratinib
• Fentanyl
• Fexinidazole
• Finerenone
• Fruquintinib
• Gestodene
• Glasdegib
• Grazoprevir
• Hemin
• Hydrocodone
• Ibrexafungerp
• Ifosfamide
• Infigratinib
• Iobenguane I 131
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Levonorgestrel
• Lisdexamfetamine
• Lorlatinib
• Lumateperone
• Lurasidone
• Medroxyprogesterone
• Meperidine
• Mestranol
• Methadone
• Mitapivat
• Mobocertinib
• Neratinib
• Nifedipine
• Nirogacestat
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olaparib
• Oliceridine
• Olutasidenib
• Omaveloxolone
• Oxycodone
• Pacritinib
• Palovarotene
• Pemigatinib
• Pentazocine
• Perampanel
• Pimavanserin
• Piperaquine
• Pirtobrutinib
• Pralsetinib
• Praziquantel
• Pretomanid
• Quizartinib
• Repotrectinib
• Rimegepant
• Ripretinib
• Segesterone
• Selpercatinib
• Selumetinib
• Sildenafil
• Simeprevir
• Sonidegib
• Sufentanil
• Tacrolimus
• Tazemetostat
• Tolvaptan
• Tramadol
• Ubrogepant
• Ulipristal
• Velpatasvir
• Venetoclax
• Voclosporin
• Vonoprazan
• Voxelotor
• Voxilaprevir
• Zanubrutinib
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clomipramine
• Ospemifene
• Triazolam

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse or dependence, history of—Dependence may be more likely to develop.

• Angina (severe chest pain), unstable or
• Heart attack, recent or
• Heart disease—Use with caution. It is not known how modafinil will affect these conditions.

• Depression, history of or
• Hypertension (high blood pressure) or
• Mania, history of or
• Psychosis (mental illness), history of—Use with caution. May make these conditions worse.

• Left ventricular hypertrophy (heart disease), history of or
• Mitral valve prolapse (heart disease) after receiving CNS stimulants—Use is not recommended in patients with these conditions.

• Liver disease, severe—Use with caution. You may require a dose adjustment. Talk with your doctor if you have concerns about this.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

This medicine does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy, sleep apnea, or shift work sleep problems. Ask your doctor for advice about good sleep habits.

If you have sleep apnea and use a continuous positive airway pressure (CPAP) machine at night, continue using this machine with modafinil.

Take this medicine at the same time each day. Do not change the time of day you take modafinil without talking first with your doctor.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For narcolepsy or obstructive sleep apnea/hypopnea syndrome:
    • Adults and teenagers 17 years of age and older—200 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed.
    • Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.
  • For shift work sleep disorder:
    • Adults and teenagers 17 years of age and older—200 milligrams (mg) one hour before you begin working.
    • Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of modafinil and you remember it before 12:00 noon the same day, take the missed dose as soon as possible.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits to make sure that this medicine is working properly. Your blood pressure may need to be checked more often while taking this medicine.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

This medicine may cause you to have a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have a skin rash; itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause serious allergic reactions affecting multiple body organs (e.g., heart, liver, or blood cells). Stop using this medicine and check with your doctor right away if you have the following symptoms: chest pain or discomfort, fever and chills, dark urine, headache, rash, stomach pain, unusual tiredness, unusual bleeding or bruising, or yellow eyes or skin.

If you think modafinil is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.

If you are using a medicine for birth control (such as birth control pills, implants, shots, patches, vaginal rings, or an IUD), it may not work properly while you are taking modafinil. To keep from getting pregnant, use another form of birth control while you are using this medicine and for one month after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Modafinil may cause some people to feel dizzy, drowsy, have trouble thinking or controlling movements, or trouble seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Stop using this medicine and check with your doctor right away if you have the following symptoms while taking the medicine: aggressive behavior, anxiety, depression, hallucinations, mania, thoughts of suicide, or other mental problems.

If you have been taking this medicine for a long time or in large doses and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on modafinil are:

• a strong desire or need to continue taking the medicine.
• a need to increase the dose to receive the effects of the medicine.
• withdrawal side effects when you stop taking the medicine.

While you are taking this medicine, be careful to limit the amount of alcohol that you drink.

If you have been taking this medicine in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Black, tarry stools

blurred vision or other vision changes

chest pain

chills or fever

clumsiness or unsteadiness

confusion

dizziness or fainting

increased thirst and urination

mental depression

problems with memory

rapidly changing moods

shortness of breath

sore throat

trembling or shaking

trouble in urinating

uncontrolled movements of the face, mouth, or tongue

unusual bleeding or bruising

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation or excitement

fast or pounding heartbeat

increased blood pressure

trouble with sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Anxiety

headache

nausea

nervousness

Less common

Back pain

belching

decrease in appetite

diarrhea

difficulty having a bowel movement

dryness of the mouth

dryness of the skin

feeling of constant movement of self or surroundings

flushing or redness of the skin

heartburn

indigestion

muscle stiffness

sores, ulcers, or white spots on the lips or in the mouth

sour stomach

stomach discomfort upset or pain

stuffy or runny nose

swelling

tingling, burning, or prickling sensations in the skin

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.