Modafinil improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy and shift work sleep disorder (SWSD); adjunctive therapy for obstructive sleep apnea/hypopnea syndrome (OSAHS).
Modafinil must be taken as directed by your doctor. You may ask your pharmacist, nurse or doctor if you do not understand these directions. Modafinil dose should be taken with a full glass of water. It is important to take modafinil regularly to get the most benefit. It is not a replacement for sleep. It may reduce the signs of sleepiness, but may not completely treat this problem. Drowsiness may continue. Hazardous activities such as driving or operating machinery should only be performed if the level of wakefulness achieved is sufficient to perform such activities. Modafinil may be habit forming; therefore, you should discuss the abuse and dependence potential of modafinil with your doctor. Do not stop taking modafinil without first talking to your doctor.
Symptoms of modafinil overdose include excitation, agitation, insomnia, sleep disturbances, anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, nausea, and diarrhea.
Take precaution when driving, operating machinery, or performing other hazardous activities. Modafinil may affect your judgment, thinking, or motor skills. If you experience any of these effects, avoid hazardous activities. Avoid alcohol while taking modafinil. If taken together with alcohol, modafinil may have altered effects. Modafinil may also decrease the effects of hormonal methods of birth control including birth control pills and depot and implantable formulations. Use a second nonhormonal form of birth control while taking modafinil, and for one month after stopping modafinil, if prevention of pregnancy is desired.
Modafinil side effects include: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); irregular heartbeats; low or high blood pressure; or shortness of breath. You may continue to take modafinil and to talk to your doctor if you experience less serious side effects such as: headache, infection, nausea, decreased appetite, diarrhea, chills, dry mouth, runny nose, sore throat, nervousness, anxiety, dizziness, insomnia, depression, or numbness or tingling.
Tell your doctor if you are taking any of the following drugs: a monoamine oxidase inhibitor (MAO inhibitor) such as isocarboxazid (Marplan), tranylcypromne (Parnate), or phenelzine (Nardil); a tricyclic antidepressant such as clomipramine (Anafranil) or desipramine (Norpramin); 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; warfarin (Coumadin); diazepam (Valium); or propranolol (Inderal).
Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.
Modafinil has the following structural formula: