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Modafinil

    Brands

    DEA Class; Rx

    Common Brand Names; Provigil

    • Stimulants

    Distinct CNS stimulant; not related to amphetamines; increases mental alertness and decreases fatigue
    In adults, used for narcolepsy and to reduce fatigue or excessive daytime sleepiness associated with sleep apnea or circadian rhythm disruptions, such as shift-work disorder
    Safety and efficacy not established for pediatric use for any indication

    Indicated for the treatment of narcolepsy to improve wakefulness in patients with excessive sleepiness.

    For the treatment of shift work sleep disorder to improve wakefulness in patients with excessive sleepiness.
    For the treatment of obstructive sleep apnea to improve wakefulness in patients with excessive sleepiness.
    For the treatment of fatigue associated with various medical conditions.
    For the adjunct treatment of symptoms (e.g., fatigue, sleepiness) associated with major depression.
    For the treatment of attention-deficit hyperactivity disorder (ADHD) in adults.

    Hypersensitivity

    • Headache (45-50%)
    • Rhinitis (11-15%)
    • Decreased appetite (16%)
    • Nausea (11%)
    • Abdominal pain (12%)
    • Nervousness (6-10%)
    • Syncope (1-5%)
    • 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
    • Aggression
    • Psychomotor hyperactivity

    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

    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

    Unknown is excreted in human milk

    Adults

    400 mg/day PO.

    Geriatric

    400 mg/day PO.

    Adolescents

    >= 17 years: 400 mg/day PO.
    <= 16 years: Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Modafinil

    tablet: Schedule IV

    • 100mg
    • 200mg