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Indications and usage:

Modafinil (Provigil) is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

Limitations of use

In OSA, modafinil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.


Dosage and administration:

The recommended dosage of Modafinil (Modalert, Provigil) for each indication is as follows:

  • Narcolepsy or OSA: 200 mg once a day in the morning.
  • SWD: 200 mg once a day, taken approximately one hour prior to start of the work shift.
  • Severe hepatic impairment: reduce dose to half the recommended dose.
  • Geriatric patients: consider lower dose.


    Dosage forms and strengths:

    Modalert, Provigil (Modafinil) tablets 100 mg and 200 mg.


    Overdosage:

    In clinical trials, a total of 151 protocol-specified doses ranging from 1000 to 1600 mg/day (5 to 8 times the recommended daily dose of modafinil) have been administered to 32 subjects, including 13 subjects who received doses of 1000 or 1200 mg/day for 7 to 21 consecutive days. In addition, several intentional acute overdoses occurred; the two largest being 4500 mg and 4000 mg taken by two subjects participating in foreign depression studies. None of these study subjects experienced any unexpected or life-threatening effects. Adverse reactions that were reported at these doses included excitation or agitation, insomnia, and slight or moderate elevations in hemodynamic parameters. Other observed high-dose effects in clinical studies have included anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, diarrhea, and decreased prothrombin time.

    From postmarketing experience, there have been reports of fatal overdoses involving modafinil alone or in combination with other drugs. Symptoms most often accompanying Provigil (Modafinil) overdose, alone or in combination with other drugs have included insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, agitation, anxiety, excitation, and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.

    Cases of accidental ingestion/overdose have been reported in children as young as 11 months of age. The highest reported accidental ingestion on a mg/kg basis occurred in a three-year-old boy who ingested 800-1000 mg (50-63 mg/kg) of Provigil. The child remained stable. The symptoms associated with overdose in children were similar to those observed in adults.

    No specific antidote exists for the toxic effects of a modafinil tablets overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.


    Contraindications:

    Known hypersensitivity to modafinil or armodafinil.


    Warnings and precautions:

  • Serious rash, including Stevens-Johnson Syndrome: discontinue Modafinil (Modalert, Provigil) tablets at the first sign of rash, unless the rash is clearly not drug-related.
  • Angioedema and anaphylaxis reactions: if suspected, discontinue this medication.
  • Multi-organ hypersensitivity reactions: if suspected, discontinue modafinil pills.
  • Persistent sleepiness: assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity.
  • Psychiatric symptoms: use caution in patients with a history of psychosis, depression, or mania. Consider discontinuing Provigil if psychiatric symptoms develop.
  • Known cardiovascular disease: consider increased monitoring.


    Adverse reactions, side effects:

    Most common adverse reactions of modafinil ( >= 5%): headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.

    To report suspected adverse reactions of Provigil (Modafinil) tablets, contact Cephalon, Teva pharmaceutical companies or your local FDA.


    Drug interactions:

  • Steroidal contraceptives (e.g., ethinyl estradiol): use alternative or concomitant methods of contraception while taking Modafinil (Provigil, Modalert) and for one month after discontinuation of the treatment with this medicine.
  • Cyclosporine: blood concentrations of cyclosporine may be reduced.
  • CYP2C19 substrates, such as phenytoin, omeprazole, and diazepam: exposure of these medications may be increased.
  • Warfarin: more frequent monitoring of prothrombin times/INR should be considered.
  • Monoamine Oxidase (MAO) inhibitors: caution should be used when concomitantly administering MAO inhibitors and modafinil.


    Use in specific populations:

    Pregnancy

    Based on animal data, modafinil pills may cause fetal harm.

    Nursing mothers

    It is not known whether modafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing woman.

    Geriatric use

    In clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups. In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses and close monitoring in this population.

    Hepatic impairment

    In patients with severe hepatic impairment, the dose of Provigil (Modafinil) tablets should be reduced to one-half of that recommended for patients with normal hepatic function.


    Drug abuse and dependence:

    Controlled substance

    Modafinil is a controlled substance in some countries (for example, Schedule IV in the United States and Canada).

    Abuse

    In humans, Modafinil (Modalert, Provigil) produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants. In in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. Modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. In some studies, modafinil was also partially discriminated as stimulant-like.

    Physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. Patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior).

    The abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. Results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants (methylphenidate).

    Dependence

    In one placebo-controlled clinical trial, the effects of modafinil withdrawal were monitored following 9 weeks of modafinil use. There were no reported withdrawal symptoms with modafinil during 14 days of observation, although sleepiness returned in narcoleptic patients.


    Patient counseling information:

    Allergic reactions

    Advise patients to stop taking Modafinil (Provigil, Modalert) tablets and to notify their physician right away if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing, or a related allergic phenomenon.

    Driving and dangerous activities

    Advise patients not to alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with Provigil has been shown to produce levels of wakefulness that permit such activities. Advise patients that modafinil is not a replacement for sleep.

    Continuing previously prescribed treatments

    Inform patients that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSA receiving CPAP should continue to do so).

    Discontinuing drug due to adverse reactions

    Advise patients to stop taking this medication and contact their physician right away if they experience chest pain, rash, depression, anxiety, or signs of psychosis or mania.

    Pregnancy

    Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Caution patients regarding the potential increased risk of pregnancy when using steroidal contraceptives (including depot or implantable contraceptives) with modafinil tablets and for one month after discontinuation of therapy.

    Nursing

    Advise patients to notify their physician if they are breastfeeding an infant.

    Concomitant medication

    Advise patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, because of the potential for interactions between Provigil (Modafinil) and other drugs.

    Alcohol

    Advise patients that the use of this medicine in combination with alcohol has not been studied. Advise patients that it is prudent to avoid alcohol while taking modafinil pills.


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