modafinil (Rx)

Brand and Other Names:Provigil
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet: Schedule IV

  • 100mg
  • 200mg

Obstructive Sleep Apnea

Indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea (OSA)

200 mg PO qAM

Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg/day dose

Narcolepsy

Indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy

200 mg PO qAM

Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg/day dose

Shift Work Sleep Disorder

Indicated to improve wakefulness in adults with excessive sleepiness associated with shift work disorder (SWD)

200 mg PO as a single dose ~1 hr prior to patient's work shift

Dosage Modifications

Hepatic impairment, severe: 100 mg PO qAM

Narcolepsy (Orphan)

Orphan designation of a fixed dose combination of modafinil and flecainide for narcolepsy

Sponsor

  • Theranexus SA; 86 Rue de Paris; Orsay, France

Safety and efficacy not established

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Interactions

Interaction Checker

and modafinil

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (45-50%)

            Rhinitis (11-15%)

            Decreased appetite (16%)

            Nausea (11%)

            Abdominal pain (12%)

            1-10%

            Nervousness (6-10%)

            Syncope (1-5%)

            Frequency Not Defined

            Arrhythmia

            Hypotension

            Hypertension

            T-wave changes

            Amnesia

            Anxiety

            Cataplexy

            Chills

            Depression

            Dizziness

            Epistaxis

            Fever

            Insomnia

            Paresthesia

            Reversible psychosis (rare)

            Tremor

            Drug hypersensitivity syndrome

            Stevens-Johnson syndrome

            Toxic epidermal necrolysis due to drug

            Anorexia

            Diarrhea

            Dry mouth

            Mouth ulcer

            Vomiting

            Abnormal LFT

            Chest pain

            Neck pain

            Dyspnea

            Pharyngitis

            Postmarketing Reports

            Aggression

            Psychomotor hyperactivity

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Risk of skin reactions (eg SJS, toxic necrolysis, and drug rash with eosinophilia and systemic symptoms); discontinue if rash or other hypersensitivity reactions occur

            May impair ability to operate heavy machinery and perform hazardous tasks

            Not recommended in patients with angina, cardiac ischemia, recent history of myocardial infarction, left ventricular hypertrophy, or mitral valve prolapse

            Use with caution in severe hepatic impairment, elderly, history of: depression, psychosis (may exacerbate psychiatric symptoms), or mania

            Use with caution in patients with Tourette syndrome; stimulants may unmask ticks

            May reduce effectiveness of steroidal contraceptives 1 month after discontinuation of drug therapy

            Reassess degree of sleepiness frequently; if used adjunctively with continuous positive airway pressure (CPAP): Periodic assessment of CPAP compliance is necessary

            Discontinue at first sign of serious rash

            Discontinue therapy if symptoms suggest angioedema or anaphylaxis

            Discontinue if multiorgan hypersensitivity reaction is suspected

            Drug interaction overview

            • CYP3A4/5 substrates
              • Modafinil moderately induces CYP3A4/5, which may result in lower systemic exposure of CYP3A4/5 substrates (eg, hormonal contraceptives, cyclosporine, midazolam, triazolam)
              • Dose adjustment of substrate may be required
            • CYP2C19 substrates
              • Modafinil weakly inhibits CYP2C19, which may result in higher systemic exposure of CYP2C19 substrates (eg, phenytoin, diazepam, propranolol, omeprazole, clomipramine)
              • Individuals deficient in CYP2D6 enzyme, the levels of CYP2D6 substrates which have ancillary routes of elimination through CYP2C19 (eg, TCAs, SSRIs), may be increased by coadministration
              • Dose adjustments of these drugs and other drugs that are substrates for CYP2C19 may be necessary if modafinil is coadministered
            • Warfarin
              • Modafinil appeared to produce a concentration-related suppression of CYP2C9 activity, therefore suggesting potential for CYP2C9 inhibition; caution if drugs that have a narrow therapeutic index
              • Consider more frequent monitoring of prothrombin times/INR
            • MAO inhibitors
              • Other CNS stimulants may induce severe cardiovascular reactions; avoid coadministration
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            Pregnancy & Lactation

            Pregnancy

            Well controlled studies in pregnant women have not been performed

            Intrauterine growth restriction and spontaneous abortion have been reported with modafinil and armodafinil

            In studies conducted in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures

            Pregnancy registry to collect information on pregnancy outcomes of women exposed to modafinil: 866-404-4106

            Lactation

            Unknown is excreted in human milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Unknown; not sympathomimetic; may increase dopamine levels in the brain by binding to the dopamine transporter and inhibiting dopamine reuptake

            Absorption

            Peak plasma time: 2-4 hr

            Distribution

            Protein bound: 60%

            Vd: 0.9 L/kg

            Metabolism

            Hepatic

            Enzymes induced: CYP1A2, CYP2B6, CYP3A4; induces its own metabolism (chronic)

            Enzymes inhibited: CYP2C19

            Elimination

            Half-life: 15 hr

            Excretion: Urine (80%)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.