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Modafinil

Class
Psychostimulants
Subclass
Eugeroics
Substance name
Modafinil
Brand names
Provigil®
Common formulations
Tablet
Dosage and administration
Adults patients
Sleepiness in patients with narcolepsy
•
200 mg PO daily
Sleepiness in patients with obstructive sleep apnea
•
200 mg PO daily
Other off-label uses
•
Treatment of ADHD
•
Treatment of chronic fatigue syndrome
•
Treatment of idiopathic hypersomnia
•
Treatment of major depressive disorder
Indications for use
Labeled indications
Adults
•
Symptomatic relief of sleepiness in patients with narcolepsy
•
Symptomatic relief of sleepiness in patients with obstructive sleep apnea
•
Symptomatic relief of sleepiness in patients with shift work disorder
Off-label indications
Adults
•
Treatment of ADHD
•
Treatment of chronic fatigue syndrome
•
Treatment of idiopathic hypersomnia
•
Treatment of major depressive disorder
Safety risks
Contraindications
Hypersensitivity to modafinil or its components or armodafinil
Warnings and precautions
Arrhythmias
•
Use caution with known cardiac disease.
Bipolar disorder
•
Use caution with a known history of mania or bipolar disorder, depression, psychosis (e.g., schizophrenia), suicidal ideation.
Drug abuse
•
Use caution with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) substance abuse.
Specific populations
Renal impairment
eGFR 20-50 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR 10-20 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 10 mL/min/1.73 m²
•
Reduce starting dose. Titrate to response.
Renal replacement therapy
Continuous renal replacement
•
Use acceptable. No dose adjustment required.
Intermittent hemodialysis
•
Reduce starting dose. Dose as in eGFR < 10 mL/min/1.73 m². Titrate to response.
Peritoneal dialysis
•
Reduce starting dose. Dose as in eGFR < 10 mL/min/1.73 m². Titrate to response.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Reduce dose by 50%. Start at dose of 100 mg daily.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. Women of childbearing potential should be informed about the risks of using this drug during pregnancy.
•
Women of childbearing potential should use effective contraception during treatment and for 2 months after stopping this drug.
•
This drug may reduce the effectiveness of oral contraceptives, alternative or additional methods of contraception are required.
Breastfeeding
Acceptable for use during breastfeeding.
Low excretion in breastmilk (5-25%).
Very low levels in breastfed infants (< 5%).
No overt adverse effects reported in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Anxiety, headache, insomnia, nausea, palpitations
Common 1-10%
•
Dyskinesia, hypertension, ↑ liver enzymes, chest pain, dizziness, dry mouth, loss of appetite, nervousness, tachycardia,
Uncommon < 1%
•
Skin rash
Unknown frequency
•
Abnormal ECG, cataplexy, DRESS syndrome, heart failure, obsessive-compulsive disorder, psychosis, fever, hallucinations, hypersalivation, mania, paranoid ideation, skin rash, suicidal ideation, Stevens-Johnson syndrome, toxic epidermal necrolysis
Interactions
Drug(s)
Check Interactions
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