Dosing & Uses
Dosage Forms & Strengths
tablet: Schedule IV
- 50mg
- 150mg
- 200mg
- 250mg
Obstructive Sleep Apnea
Indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea (OSA)
150 mg PO qAM
Doses up to 250 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 150 mg/day dose
Narcolepsy
Indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy
150-250 mg PO qAM
Shift Work Sleep Disorder
150 mg PO as a single dose ~1 hour before patient's work shift
Dosage Modifications
Hepatic impairment
- Severe: Reduce dose
Dosing Considerations
Limitations of use
- In OSA, indicated to treat excessive sleepiness and not as treatment for the underlying obstruction
- If continuous positive airway pressure (CPAP) is the treatment of choice, maximal effort to treat with CPAP for an adequate period of time should be made before initiating armodafinil
In obstructive sleep apnea, indicated to treat excessive sleepiness and not as treatment for the underlying obstruction
Safety and efficacy not established
Consider lower initial dose
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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
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
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
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
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
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 (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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Patient Handout
Formulary
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