Classifications: cns stimulant, analeptic; Therapeutic:cns stimulant
Pregnancy Category: C
Controlled Substance: Schedule IV
100 mg, 200 mg capsules; 50 mg, 150 mg, 200 mg tablets
Primary sites of CNS stimulant activity of modafinil appear to be in the hippocampus, the centrolateral nucleus of the
thalamus, and the central nucleus of the amygdala. Limited animal studies demonstrate that modafinil may increase excitatory
glutaminergic transmission in the thalamus and hippocampus.
Modafinil causes wakefulness, increased locomotor activity, and psychoactive and euphoric effects.
Improve wakefulness in patients with narcolepsy or excessive sleepiness associated with shift work sleep disorder, obstructive
sleep apnea/hypopnea syndrome.
Fatigue related to organic brain syndrome or multiple sclerosis.
Hypersensitivity to modafinil; acute MI, valvular heart disease; pregnancy (category C); lactation. Safety and efficacy
in children <16 y are unknown.
Cardiovascular disease including left ventricular hypertrophy; cardiac disease, ischemic ECG changes, chest pain, arrhythmias,
mitral valve prolapse, recent MI, unstable angina; older adults; history of drug or alcohol abuse; psychosis or emotional
instability; leukopenia, MI, neurological disease, hypertension, severe hepatic disease, severe renal impairment, renal
failure, seizure disorder, sleep apnea.
Route & Dosage
Adult: PO (Provigil) 200 mg/d as single dose in the morning; (Nuvigil) 150250 mg q a.m.
Shift-Work Sleep Disorder
Adult: PO (Nuvigil) 150 mg 1 h prior to shift
Reduce dose by 50%.
- Give in the morning shortly after awakening.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)Body as a Whole:
Chest pain, neck pain, chills, eosinophilia. CNS: Headache,
nervousness, dizziness, depression
, anxiety, cataplexy, insomnia
, paresthesia, dyskinesia, hypertonia. CV:
Hypotension, hypertension, vasodilation, arrhythmia, syncope. GI: Nausea,
diarrhea, dry mouth, anorexia, abnormal LFTs, vomiting, mouth ulcer, gingivitis, thirst. Respiratory:
Rhinitis, pharyngitis, lung disorder, dyspnea. Skin:
Dry skin. Special Senses:
Amblyopia, abnormal vision.
may delay absorption of modafinil; modafinil
may decrease levels of cyclosporine, oral contraceptives
may increase levels of clomipramine, phenytoin, warfarin, tricyclic antidepressants
Rapidly absorbed. Peak:
24 h. Distribution:
Approximately 60% protein bound. Metabolism:
In liver to inactive metabolites. Elimination:
In urine. Half-Life:
Assessment & Drug Effects
- Therapeutic effectiveness: Indicated by improved daytime wakefulness.
- Monitor BP and cardiovascular status, especially with preexisting hypertension and mitral valve prolapse or other CV condition.
- Monitor for S&S of psychosis, especially when history of psychotic episodes exists.
- Lab tests: Periodic liver function tests.
- Coadministered drugs: Monitor INR with warfarin for first several months and when dosage is changed; monitor for toxicity
Patient & Family Education
- Use barrier contraceptive instead of/in addition to hormonal contraceptive.
- Inform physician of all prescription or OTC drugs in/added to your regimen.
- Notify physician if any S&S of an allergic reaction appear.