Medications and Drugs

GENERIC NAME: modafinil

BRAND NAME: Provigil

DRUG CLASS AND MECHANISM: Modafinil is an oral drug that is used for improving wakefulness in patients with excessive sleepiness. The effect of modafinil is similar to caffeine. Both drugs promote wakefulness by stimulating the brain. Thus, both drugs are considered stimulants. Other stimulants, for example, dextroamphetamine (Dexedrine) and sibutramine (Meridia), also have the different effect of suppressing appetite. All four of these drugs affect the neurotransmitters in the brain, the chemicals that the nerves of the brain use to communicate with each other; however, they affect the neurotransmitters differently. Modafinil was approved by the FDA in December, 1998.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Tablets: 100 mg and 200 mg.

STORAGE: Modafinil should be stored at room temperature, 15-30°C(59-86°F).

PRESCRIBED FOR: Modafinil is used to promote wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (as an adjunct for treatment of the underlying obstruction), and shiftwork sleep disorder. Narcolepsy is a chronic disease of the brain and spinal cord characterized most commonly by a recurrent, uncontrollable desire to sleep.  Shiftwork sleep disorder is a condition in which the normal rhythm of sleep is disturbed, often as a result of working at night.

DOSING: Modafinil usually is taken at a dose of 200 or 400 mg daily, although the 400 mg dose has not been shown to be more effective than the 200 mg dose. Modafinil can be taken with or without food.

DRUG INTERACTIONS: Modafinil can decrease or increase the activity of enzymes in the liver that metabolize (eliminate) other drugs. This can result in decreased levels of some drugs that reduce their effectiveness and increased levels of other drugs that leads to their toxicity. Modafinil treatment should be carefully monitored if taken with any of these drugs.

Drugs which may have reduced effectiveness if taken with modafinil include cyclosporine (Sandimmune), theophylline, and hormonal contraceptives such as progestin-only or estrogen and progesterone containing drugs (e.g., Micronor, Ortho-Novum 1/50). Alternative hormonal contraceptives or an additional non-drug form of contraception should be considered during treatment with modafinil, and treatment should continue for one month after modafinil therapy ends (since the effects of modafinil on contraceptive hormones may continue for several weeks). The effects of modafinil on hormonal contraceptives occurs if the hormones are taken by mouth, patch, or implant.

Drugs that may show increased effects or toxicity if taken with modafinil include warfarin (Coumadin), diazepam (Valium), propranolol (Inderal), imipramine (Tofranil), desipramine (Norpramin), phenytoin (Dilantin) and mephenytoin (Mesantoin).

Some other drugs that may increase the effectiveness and/or toxicity of modafinil. These drugs include carbamazepine (Tegretol), phenobarbital, and rifampin (Rifadin). Other drugs, such as ketoconazole (Nizoral) and itraconazole (Sporanox) may reduce the effectiveness of modafinil.

It is not clear if there are interactions between modafinil and alcohol.

PREGNANCY: Modafinil is toxic to rat embryos. There are no adequate studies that assess effects of modafinil in pregnant women.

NURSING MOTHERS: It is not known if modafinil is excreted in breast milk.

SIDE EFFECTS: The most common side effects of modafinil in clinical trials are headache, upper respiratory tract infection, nausea, nervousness, anxiety and insomnia. These each occur in more than 5% of patients.

Pharmacy Author: Marilyn A.D. Yee, Pharm.D.
Medical and Pharmacy Editor: Jay W.Marks, M.D.

Reference: FDA Prescribing Information

Last Editorial Review: 8/10/2004

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