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What is Modafinil (Provigil)?
Doctors prescribe modafinil, sold under the brand name Provigil, to improve wakefulness in adults who are experiencing excessive sleepiness as a result of obstructive sleep apnea, shift work sleep disorder, or narcolepsy.
The Food and Drug Administration (FDA) approved modafinil for the treatment of narcolepsy in 1998, and the agency approved its use for shift work sleep disorder and obstructive sleep apnea/hypopnea in 2003.
Researchers are not sure exactly how modafinil promotes wakefulness. One theory is that it may increase dopamine levels in the brain by inhibiting reuptake of dopamine, a neurotransmitter that moderates the way chemical signals move from one nerve cell to another.
Provigil is made by Cephalon, Inc. in two strengths, 100 mg and 200 mg. Various manufacturers, including Mylan Pharmaceuticals, Teva Pharmaceutical Industries, and Par Pharmaceutical Companies make the generic form. (Teva's version of modafinil is actually brand-name Provigil that has been repackaged and sold as a generic.)
Cephalon Inc., which is now owned by Teva, won a court case that resulted in the dismissal of claims that it conspired with the makers of generics to delay cheaper versions of Provigil.
Modafinil enhances short-term memory allowing users to stay awake for long periods of time. It is sometimes used for performance enhancement by military pilots and soldiers during combat situations, and some now call it a "super drug". Its off-label uses have contributed to an ongoing debate on how far to push the human body through the use of drugs.
In This Section:
What Are the Key Things I Need to Know About Modafinil (Provigil)?
Modafinil is a federally controlled substance and should be used only as directed. Store it in a safe place to prevent misuse and abuse. It is against the law to sell or give modafinil to another person.
The drug is not approved for use in children for any medical condition, and it's unknown whether it's safe or works in children under the age of 17.
For those who have obstructive sleep apnea, modafinil is used in conjunction with other medical treatments. It will not cure this or other sleep disorders, but it can help the sleepiness created by these conditions. It may not stop all your sleepiness, however, and it's not a substitute for getting proper rest.
Modafinil can lead to serious side effects, including a serious rash or an allergic reaction affecting your liver or blood cells. These side effects may be life threatening and may require hospital treatment. You should stop taking the drug right away and call your doctor if you develop a skin rash, hives, sores in your mouth, blisters, peeling, or yellowing of your skin or eyes, trouble swallowing or breathing, dark urine or fever.
Don't take modafinil if you are allergic to armodafinil (Nuvigil), lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone and magnesium stearate.
Is There Anything Special I Should Discuss with My Doctor Before Taking Modafinil (Provigil)?
It's important for people to talk to their doctors about all their health conditions before starting this medication, such as whether they have a history of mental health problems, including psychosis. Make sure your doctor is aware of any heart problems or if you have had a heart attack, have high blood pressure, liver or kidney illness, a history of drug or alcohol abuse or addiction, or if you are pregnant, planning to become pregnant or are breastfeeding. It is unknown whether the drug will pass into breast milk.
Be sure to tell the doctor about any and all medications you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements. In addition, if you are using hormonal birth control, you could have a higher chance of getting pregnant while on this medication, and one month after stopping it.
For those who do get pregnant while taking the medication, there is a registry available that collects and provides information about the safety of the drug. You can access the information by enrolling in the registry by calling 1-866-404-4106 or logging onto www.PROVIGILpregnancyregistry.com.
Modafinil Side Effects
What Are the Most Common and Serious Side Effects of Modafinil (Provigil)?
Not all side effects need medical attention and may go away during treatment as your body adjusts to the medicine. Your doctor may also be able to help you prevent or reduce some of them.
The more common side effects range from anxiety and nausea to headache and nervousness.
The more common side effects include:
People should also be on the lookout for a number of other side effects, which are not as common. Among them: back pain, a reduction in appetite, belching, diarrhea or having problems making a bowel movement.
In addition, other people may experience dryness of the skin or mouth, flushing or redness of the skin, feeling like they are constantly moving, have heartburn/indigestion, vomiting and muscle stiffness.
Less common side effects of Provigil include:
- Elevated blood pressure
- Sores, ulcers, or white spots on the lips or inside the mouth
- Stuffy/runny nose
- Tingling, burning, or prickling sensations in the skin
- Back pain
- Decrease in appetite
- 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 and indigestion
- Muscle stiffness
Stop taking the medication and call your doctor and/or get emergency help if you get any of the following serious side effects:
- Chest pain
- Trouble breathing
- Sore throat
- Blistering, peeling, and red skin rash
- Severe tingling, numbness, pain, muscle weakness
- Easy bruising or bleeding
- White patches or sores inside your mouth or on your lips
- Feeling anxious
- Sensing things that are not really there (hallucinations)
- Increase in activity (mania)
- Thoughts of suicide
- Aggression or other mental problems
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Do Other Drugs Affect the Way Modafinil (Provigil) Works?
Before starting modafinil, it's important to inform your doctor about any and all medications you're taking, including prescription, over-the-counter, vitamins and herbal products.
Many drugs may interact with modafinil, such as Propranolol or Inderal, Cyclosporine/ Neoral, Sandimmune, Gengraf; Rifampin/Rifadin, Rimactane, Rifater; sedatives like diazepam/Valium, midazolam/Versed or triazolam/Halcion as well as antifungal medications like itraconazole/Sporanox or ketoconazole/Nizoral.
Other drugs which may interact include:
- Carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton)
- Amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others
- Isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate)
- Cyclosporine (Neoral, Sandimmune, Gengraf)
- Propranolol (Inderal)
- Rifampin (Rifadin, Rimactane, Rifater)
- A sedative such as diazepam (Valium), midazolam (Versed), or triazolam (Halcion)
- Antifungal medications 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
- A MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate)
Should I Avoid Any Food, Drink or Activity While Taking Modafinil (Provigil)?
Modafinil affects the central nervous system so your thinking and reactions may be impaired.
Don't drive a car or engage in other activities that require you to be alert.
Avoid drinking alcohol since it is unknown how this will affect you.
In This Section:
What Are the Typical Dosages for Modafinil (Provigil)?
Modafinil comes in two strengths, 100 mg and 200 mg. It is usually taken in the morning to prevent daytime sleepiness or one hour before the start of a work shift.
If you are using the medication to treat obstructive sleep apnea, you may also be given a continuous positive airway pressure (CPAP) machine. The air pump is connected to a mask that blows pressurized air into your nose while you sleep, helping to keep your airways open to prevent obstruction.
Remember, the medication is not intended to take the place of getting proper sleep.
What Happens If I Take Too Much and Overdose?
If you feel you have taken too much modafinil or may have overdosed, seek emergency medical attention or call the Poison Helpline at 1-800-222-1222.
If you feel excited or agitated, confused, have trouble sleeping, experience nausea or diarrhea, these may be symptoms of overdose.
What Happens if I Miss a Dose or Don't Take It As Prescribed?
It's important to discuss how to handle a missed dose with your doctor. Don't take extra medicine to make up for the missed dose.
If you miss a dose of modafinil, you should take it as soon as you remember. However, don't take the medication unless you plan to be awake for several hours.
If it is close to your normal bedtime, you might want to skip the missed dose.
Video: Modafinil: What You Need To Know
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