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a central nervous system stimulant used in the treatment of narcolepsy.


Alertec (CA), Apo-Mofafinil (CA), Provigil

Pharmacologic class: Nonamphetamine CNS stimulant

Therapeutic class: Analeptic

Controlled substance schedule IV

Pregnancy risk category C


Unknown. Thought to stimulate CNS by decreasing the release of gamma-aminobutyric acid (a CNS depressant), thereby increasing mental alertness.


Tablets: 100 mg, 200 mg

Indications and dosages


Adults: 200 mg/day P.O. as a single dose in morning

Dosage adjustment

• Severe hepatic impairment


• Hypersensitivity to drug


Use cautiously in:

• recent myocardial infarction, unstable angina, severe hepatic impairment, hyperthyroidism, hypertension, glaucoma, anxiety

• history of left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmias, or mitral valve prolapse with previous CNS stimulant use

• history of psychosis

• drug abuse

• pregnant or breastfeeding patients

• children (safety and efficacy not established).


• Give without food (food delays drug absorption).

Adverse reactions

CNS: headache, dizziness, nervousness, insomnia, depression, anxiety, amnesia, tremor, emotional lability

CV: hypertension, chest pain, vasodilation, hypotension, syncope, arrhythmias

EENT: abnormal vision, amblyopia, epistaxis, rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, dry mouth, anorexia

GU: abnormal urine, urinary retention, albuminuria, abnormal ejaculation

Hematologic: eosinophilia

Metabolic: hyperglycemia

Musculoskeletal: joint disorders, neck pain and rigidity

Respiratory: lung disorder, dyspnea, asthma

Skin: dry skin

Other: fever, chills, herpes simplex infection


Drug-drug. Carbamazepine, phenobarbital, rifampin, other CYP3A4 inducers: decreased modafinil blood level

Cyclosporine, theophylline: decreased blood levels of these drugs

Diazepam, phenytoin, propranolol, tricyclic antidepressants, warfarin: increased blood levels of these drugs

Hormonal contraceptives: decreased contraceptive efficacy

Itraconazole, ketoconazole, other CYP3A4 inhibitors: increased modafinil blood level

Methylphenidate: delayed modafinil absorption

Drug-diagnostic tests. Aspartate aminotransferase, eosinophils, gamma-glutamyl transferase, glucose: increased levels

Hepatic enzymes: abnormal levels

Patient monitoring

• Monitor respiratory and cardiovascular status, including vital signs and ECG.

• Monitor neurologic status, including mood, motor function, cognition, and emotional lability.

• Monitor blood glucose level in diabetic patient.

• Monitor patient carefully if he is also receiving MAO inhibitors. (However, interaction studies with MAO inhibitors haven't been done.)

Patient teaching

• Tell patient he may take with or without food, but that food may delay drug absorption up to 1 hour.

Advise patient to immediately report chest pain, irregular heart beats, light-headedness, or fainting.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, motor function, and alertness.

• Instruct female patient to use reliable nonhormonal contraception during and for 1 month after therapy.

• Tell diabetic patient to monitor blood glucose level closely and stay alert for hyperglycemia.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


/mo·daf·i·nil/ (mo-daf´ĭ-nil″) a central nervous system stimulant used in the treatment of narcolepsy.


A nonamphetamine stimulant drug that causes long-lasting wakefulness, used to treat patients with narcolepsy and other disorders.


a cerebral stimulant.
indication It is used to treat narcolepsy.
contraindications Factors that prohibit its use include hyperthyroidism, hypertension, glaucoma, severe arteriosclerosis, drug abuse, cardiovascular disease, anxiety, and known hypersensitivity to this drug.
adverse effects Arrhythmias are a life-threatening effect of this drug. Other adverse effects are hyperglycemia, albuminuria, rhinitis, pharyngitis, lung disorder, dyspnea, asthma, epistaxis, abnormal vision, amblyopia, dizziness, headache, chills, stimulation, anorexia, dry mouth, diarrhea, nausea, vomiting, mouth ulcer, gingivitis, thirst, urinary retention, abnormal ejaculation, hypertension, herpes simplex, and dry skin. Common side effects include hyperactivity, insomnia, restlessness, palpitations, and tachycardia.


Provigil® Neurology A nonamphetamine antinarcoleptic used as a 1st-line treatment of excess daytime sleepiness in narcolepsy. See Narcolepsy.


A non-amphetamine (amfetamine) nervous system stimulant used to treat NARCOLEPSY and sleep apnoea. Modafinil is an ampakine that boosts the activity of the neurotransmitter glutamate. It is being widely used by people with reasons to wish to remain awake and alert. A brand name is Provigil.
References in periodicals archive ?
52) However, the doses of methylphenidate and dextroamphetamine were at or above the high range of recommended doses, whereas modafinil was in the middle range of prescribed doses; the total number of patients examined in each study surveyed ranged from 5 for dextroamphetamine to 21 for modafinil.
The Food and Drug Administration has approved modafinil (Provigil) for treatment of narcolepsy and is currently reviewing a special pediatric formulation for ADHD.
In this case, our preliminary finding is that Teva and Cephalon broke EU antitrust rules by agreeing on Cephalon paying Teva to keep its cheaper generic version of Cephalon's sleep disorder drug modafinil out of the market.
El 5 de agosto, la FIE confirmo a la deportista la presencia de modafinil tambien en la muestra B.
Many of these drugs and substances are taken without any knowledge of side effects and without any evidence of efficacy, but recently researchers at Harvard and Oxford Universities have published the first review on Modafinil in which they imply that this is the first 'safe' smart drug.
Modafinil, marketed as Provigil in the US, is a prescription-only drug used to improve wakefulness in those who suffer from sleep disorders like narcolepsy.
Pharmaceutical company Mylan Inc (NasdaqGS:MYL) reported on Friday the receipt of final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP,100 mg and 200 mg.
The two drugs most beneficial as adjunctive therapy for these patients are modafinil (Provigil) and armodafinil (Nuvigil).
says it has begun shipping all strengths of modafinil tablets under U.
The Commission determined that the two groups have a similar generic drug based on the same active ingredient as Provigil, namely modafinil, and that competition on the generic drug markets where modafinil is sold could be hampered.
The EC asked Teva to sell Cephalon's marketing authorisation of generic modafinil in France and allow further rights to the buyer in the European economic area, the firms said.
have had the object or effect of hindering the entry of generic Modafinil in