Dosing and uses of Nuvigil (armodafinil)
Adult dosage forms and strengths
tablet: Schedule IV
- 50mg
- 150mg
- 200mg
- 250mg
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
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
Consider lower initial dose
Nuvigil (armodafinil) adverse (side) 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
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
Toxic epidermal necrolysis, Stevens-Johonson syndrome, and life-threatening rashes reported; discontinue at first sign of serious rash
Discontinue therapy if symptoms suggest angioedema or anaphylaxis
Discontinue if multiorgan hypersensitivity is suspected
Pregnancy and lactation
Pregnancy category: C
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.
Pharmacology of Nuvigil (armodafinil)
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%)
