Drug Database - Provigil

Generic Name: modafinil (moe-DA-fih-nill)

Brand Names: Provigil®

Classification: Treatment of Narcolepsy (and FM)

Issue Date: 2002

Provigil, originally developed and approved for the treatment of narcolepsy, also has FDA approval for treating shift work sleep disorder and obstructive sleep apnea.

In addition to being used off-label to treat FM fatigue, it is also sometimes used in the treatment of other problems, including: Alzheimer's disease, depression, attention-deficit disorder (ADHD), myotonic dystrophy, multiple sclerosis-induced fatigue, post-anesthesia grogginess, cognitive impairment in schizophrenia, spasticity associated with cerebral palsy, age-related memory decline, idiopathic hypersomnia, jet-lag, and everyday cat-napping.

Use caution when driving, operating machinery, or performing other hazardous activities. Provigil may affect your judgment, thinking, or motor skills. If you experience any of these effects, avoid hazardous activities. It is best to avoid alcohol while taking Provigil. Alcohol or Provigil may have altered effects if taken together.

Provigil may decrease the effects of hormonal methods of birth control including birth control pills and depot and implantable formulations (e.g., Norplant, Depo-Provera). Use a second, nonhormonal form of birth control while taking Provigil, and for one month after stopping Provigil, if prevention of pregnancy is desired.

Provigil may be habit forming. You should discuss the abuse and dependence potential of Provigil with your doctor. Do not stop taking Provigil without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment.

Take Provigil exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. Take each dose with a full glass of water.

Provigil can be taken with or without food. Provigil is usually taken once a day. Follow your doctor's instructions. It is important to take Provigil regularly to get the most benefit.

Provigil is not a replacement for sleep. Provigil may reduce the signs of sleepiness, but may not completely treat this problem. Some drowsiness may continue. Potentially hazardous activities such as driving or operating machinery should only be performed if the level of wakefulness achieved is sufficient to permit such activities.

Other treatments such as CPAP (continuous positive airway pressure) use should be continued as directed by your doctor if you have obstructive sleep apnea/hypoapnea syndrome (OSAHS) and are taking Provigil.

Provigil may be habit forming. You should discuss the abuse and dependence potential of Provigil with your doctor. Do not stop taking Provigil without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment. Store Provigil at room temperature away from moisture and heat.

Before taking Provigil, tell your doctor if you have:

• left ventricular hypertrophy (enlarged left heart ventricle)
• chest pain, irregular heartbeats, or other symptoms of mitral valve prolapse
• a recent history of a heart attack
• high blood pressure
• angina (chest pain)
• abused medicines called stimulants or street drugs
• a history of mental illness
• kidney disease
• liver disease

You may not be able to take Provigil, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Provigil is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take Provigil without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Provigil passes into breast milk. Do not take Provigil without first talking to your doctor if you are breast-feeding. If you are older than 65 years of age, you may be more likely to experience side effects from Provigil. You may require a lower dose or special monitoring during treatment.

Take the missed dose as soon as you remember as directed by your doctor. A missed dose taken late in the waking day may cause insomnia. If you don't remember until it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• skin rash or hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

If you experience any of the following uncommon but serious side effects, stop taking Provigil and seek emergency medical attention or contact your doctor immediately:

• irregular heartbeats
• low or high blood pressure
• shortness of breath

Less serious side effects are more likely to occur, such as:

• headache
• infection
• nausea, decreased appetite, or diarrhea
• chills
• dry mouth
• runny nose
• sore throat
• nervousness
• anxiety
• dizziness
• insomnia
• depression
• numbness or tingling

Provigil may be habit forming. You should discuss the abuse and dependence potential of Provigil with your doctor. Do not stop taking Provigil without first talking to your doctor. Your doctor may want to gradually lower the dose of the medication before stopping treatment.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Provigil may decrease the effects of hormonal methods of birth control including birth control pills and depot and implantable formulations (e.g., Norplant®, Depo-Provera®). Use a second, nonhormonal form of birth control while taking Provigil, and for one month after stopping Provigil, if prevention of pregnancy is desired.

Before taking Provigil, tell your doctor if you are taking any of the following drugs:

• a monoamine oxidase inhibitor (MAO inhibitor) such as:
• isocarboxazid (Marplan®)
• tranylcypromine (Parnate®)

• phenelzine (Nardil®)
• another CNS stimulant such as:
• amphetamine-dextroamphetamine (Adderall®)
• methylphenidate (Ritalin, Methylin®, Metadate ER®, Concerta®)
• pemoline (Cylert®), and others

• phenytoin (Dilantin®)
• carbamazepine (Tegretol®)
• phenobarbital
• rifampin (Rifadin®, Rimactane®)
• ketoconazole (Nizoral®)
• itraconazole (Sporanox®)
• cyclosporine (Neoral®, Sandimmune®)
• theophylline (Theolair®, Theochron®, Theo-Bid®, Theo-Dur®, Elixophyllin®, Slo-Phyllin®, and others)
• warfarin (Coumadin®)
• diazepam (Valium®)
• propranolol (Inderal®)

You may not be able to take Provigil, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

There may be other drugs not listed that can affect Provigil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor