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Reports of serious dermatologic adverse effects and psychiatric events has resulted in the FDA's Pediatric Advisory Committee unanimously recommending that a specific warning against the use of modafinil in children be added to the manufacturer's labeling; use only if first- and second-line treatments have failed and the benefits outweigh the risks.

More Pregnancy Warnings
Children more than 30 kg: 300-425 mg


If you are taking Provigil 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.
Support Group Q & A
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.

chest pain, trouble breathing, uneven heart beats; or
How should I take Provigil?


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Provigil only for the indication prescribed.
You may take the tablet with or without food.

the first sign of any skin rash, no matter how minor you think it might be.
Interactions
Before taking this medicine

Provigil side effects
Pricing & Coupons

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and Provigil may be necessary to best treat your condition.

Important information



Other drugs may interact with modafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.


Provigil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have:
mouth sores, trouble swallowing;
Get emergency medical help if you have signs of an allergic reaction to Provigil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Provigil may also be used for purposes not listed in this medication guide.





10 Common Sleep Disorders: Treatments and Truths

Not FDA approved.

What should I avoid while taking Provigil?
Slideshow


What is Provigil?
Modafinil affects the central nervous system. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activities until you know how this medication will affect your level of wakefulness.
You should not use Provigil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).


kidney disease;
Provigil can make certain birth control less effective. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Talk with your doctor about the best methods of birth control to use while taking Provigil.

depression, anxiety, suicidal thoughts or actions;

Usual Adult Dose for Narcolepsy:

Your pharmacist can provide more information about Provigil.
See also: Dosage Information (in more detail) What happens if I miss a dose?
skin rash or hives, blisters or peeling;

200 mg orally daily one hour prior to the start of the work shift



You should not use Provigil if you have ever had an allergic reaction or skin rash while taking modafinil or armodafinil (Nuvigil).


back pain;
angina (chest pain);
Stop using Provigil and call your doctor at once if you have:
Provigil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.

See also: Side effects (in more detail) What other drugs will affect Provigil?


Provigil can cause skin reactions that may be severe enough to need treatment in a hospital. Stop taking this medicine and get emergency medical help if you have a skin rash or hives, blisters or peeling, mouth sores, trouble breathing or swallowing, fever, swelling in your legs, dark urine, yellowing of your skin or eyes, or swelling in your face.
Taking Provigil does not take the place of getting enough sleep.
Talk with your doctor about what to do if you miss a dose of Provigil. Avoid taking the medicine if you do not plan to be awake for several hours. Skip the missed dose if it is almost bedtime. Do not take extra medicine to make up the missed dose.

Usual Adult Dose for Shift Work Sleep Disorder:
Professional
cirrhosis or other liver problem;



feeling nervous or anxious;


Drug Images
a history of mental illness or psychosis; or





Dosage

Where can I get more information?


200 mg orally daily in the morning
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sleep problems (insomnia); or
Common Provigil side effects may include:


Provigil 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.
What happens if I overdose?
Provigil dosing information

history of alcoholism or drug addiction.


Provigil is used to treat excessive sleepiness caused by sleep apnea , narcolepsy , or shift work sleep disorder.


Provigil is usually given for 12 weeks or less.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
headache, dizziness;
Take Provigil exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.




It is not known whether modafinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.


Overview
nausea, diarrhea, upset stomach;
This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.




Before using Provigil, 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.
Side Effects
hallucinations, unusual thoughts or behavior, aggression, being more active or talkative than usual;
swelling in your face, eyes, lips, tongue, or throat.
Disclaimer: 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.

dark urine, jaundice (yellowing of the skin or eyes); or
Store at room temperature away from moisture and heat.



Generic Name: modafinil (moe DAF i nil) Brand Names: Provigil
Modafinil may be habit-forming. Never share Provigil with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Provigil (modafinil) is a medication that promotes wakefulness. It is thought to work by altering the natural chemicals (neurotransmitters) in the brain.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
200 mg orally daily in the morning


Avoid other dangerous activities until you know how Provigil will affect your level of wakefulness.
User Reviews




Avoid drinking alcohol while taking modafinil.


swelling in your legs;
Usual Pediatric Dose for Attention Deficit Disorder:
Children less than 30 kg: 200-340 mg once daily
high blood pressure, heart disease, or history of heart attack;
Consumer resources Provigil Provigil (Advanced Reading) Professional resources Provigil (AHFS Monograph) Provigil (FDA) Related treatment guides Shift Work Sleep Disorder Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome
Call your doctor if you continue to have excessive sleepiness even while taking this medicine.
Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:


More about Provigil (modafinil) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Espanol 142 Reviews - Add your own review/rating Generic Availability
Provigil is not approved for use by anyone younger than 17 years old.
Keep track of the amount of medicine used from each new bottle. Modafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
fever, shortness of breath;

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To make sure Provigil is safe for you, tell your doctor if you have:
Randomized, double-blind, placebo-controlled pediatric studies have utilized an 85 mg film-coated tablet (currently not commercially available) to provide these dosages. All studies utilized a titration method but varied the length of titration (3 weeks vs 7-9 days); clinical improvement was noted earlier in the shorter titration period.

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