armodafinil (Rx)

Brand and Other Names:Nuvigil
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet: Schedule IV

  • 50mg
  • 150mg
  • 200mg
  • 250mg
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Obstructive Sleep Apnea/Hypopnea Syndrome

150-250 mg PO qAM

Narcolepsy

150-250 mg PO qAM

Shift Work Sleep Disorder

150 mg PO qDay 1 hour prior to patient's work shift

Limitation of Use

In obstructive sleep apnea, indicated to treat excessive sleepiness and not as treatment for the underlying obstruction

Dosing Modifications

Hepatic impairment: Reduce dose

Renal impairment: Safety and efficacy not established

Safety and efficacy not established

Consider lower initial dose

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Interactions

Interaction Checker

and armodafinil

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 (14-23%)

            1-10%

            Nausea (6-9%)

            Dry mouth (2-7%)

            Dizziness (5%)

            Anxiety (4%)

            Diarrhea (4%)

            Insomnia (4%)

            Rash (1-4%)

            Depression (1-3%)

            Dyspepsia (2%)

            Fatigue (2%)

            Palpitations (2%)

            Agitation (1%)

            Anorexia (1%)

            Attention disturbances (1%)

            Contact dermatitis (1%)

            Dyspnea (1%)

            Hyperhidrosis (1%)

            Nervousness (1%)

            Paresthesia (1%)

            Pyrexia (1%)

            <1%

            Angioedema

            Dysphagia

            Bronchospasm

            Reversible psychosis

            Postmarketing Reports

            Aggression

            Mouth Sores

            Persistent sleepiness

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            Warnings

            Contraindications

            Hypersensitivity to modafinil, armodafinil, or other ingredients

            Cautions

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

            Use caution in patients with history of left ventricular hypertrophy/mitral valve prolapse who have had mitral valve prolapse syndrome when previously receiving CNS stimulants; consider increased monitoring

            Use caution in severe hepatic impairment and the elderly

            History of depression, psychosis, mania; consider discontinuing armodafinil if psychiatric symptoms develop

            Consider dose adjustment of CYP3A4/5 substrate medications

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

            If used adjunctively with continuous positive airway pressure (CPAP), periodic assessment of CPAP compliance is necessary

            Rash resulting in discontinuation reported; rashes included 1 case of possible Stevens-Johnson syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction/ Drug Rash with Eosinophilia and Systemic Symptoms (DRESS); rare cases of serious or life-threatening rash, toxic epidermal necrolysis (TEN) reported in adults and children

            Serious rash requiring hospitalization and discontinuation of treatment has been reported; discontinue at first sign of serious rash

            Discontinue therapy if symptoms suggest angioedema or anaphylaxis

            Skin and mouth sores, blistering, and ulceration reported

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            Pregnancy & Lactation

            Pregnancy

            Limited available data in pregnant women are insufficient to inform about drug associated risk of adverse pregnancy outcomes; intrauterine growth restriction and spontaneous abortion reported in association with armodafinil and modafinil; although the pharmacology of armodafinil not identical to that of sympathomimetic amines, armodafinil shares some pharmacologic properties with this class; sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions

            Effectiveness of hormonal contraceptives may be reduced up to for one month after discontinuation of therapy; advise women who using a hormonal method of contraception to use additional barrier method or alternative non-hormonal method of contraception during treatment and for one month after discontinuation of treatment

            Lactation

            There are no data on presence of armodafinil or metabolite in human milk, effects on breastfed infant, or effect of this drug on milk production; modafinil was present in rat milk when animals were dosed during the lactation period; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for armodafinil and any potential adverse effects on breastfed child from armodafinil or from underlying maternal condition

            Lactation: Unknown if excreted in milk; use caution

            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 (R-enantiomer of modafinil); may increase dopamine levels in the brain by binding to the dopamine transporter and inhibiting dopamine reuptake

            Absorption

            Peak plasma time: 2 hr

            Distribution

            Protein bound: 60%

            Vd: 42 L

            Metabolism

            Hepatic; primarily amide hydrolysis; also sulfone formation by CYP3A4/5

            Enzymes induced: CYP1A2, possibly CYP3A4 in a concentration-related manner

            Enzymes inhibited: CYP2C19

            Pharmacokinetics

            Half-life: 15 hr

            Excretion: Urine (80%)

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            Formulary

            FormularyPatient Discounts

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            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.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the 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.