Dosing and uses of Provigil (modafinil)
Adult dosage forms and strengths
tablet: Schedule IV
- 100mg
- 200mg
Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
200 mg PO qAM; no more than 400 mg
Narcolepsy
200 mg PO qAM; not to exceed 400 mg
Shift Work Sleep Disorder
200 mg PO 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
Other Indications & Uses
Off-label: Reduce fatigue in MS patients, depression
Pediatric dosage forms and strengths
tablet: Schedule IV
- 100mg
- 200mg
Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
<16 years
- Not recommended
≥16 years
- 200 mg PO qAM; not to exceed 400 mg
Narcolepsy
<16 years
- Not recommended
≥16 years
- 200 mg PO qAM; not to exceed 400 mg
Shift Work Sleep Disorder
<16 years
- Not recommended
≥16 years
- 200 mg PO 1 hr prior to patient's work shift
Provigil (modafinil) adverse (side) 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
Consider dose adjustment of CYP3A4/5 substrate medications
Use with caution in patients with Tourette's 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
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown; 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 Provigil (modafinil)
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%)
