Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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
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
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.
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%)
Images
Patient Handout
Formulary
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Adding plans allows you to:
- 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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