modafinil PROVIGIL

Class: Wakefulness-promoting Agent
FDA Indications: Narcolepsy, Shift Work Sleep Disorder (SWSD), Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS), Narcolepsy
Off-Label Use: Jet Lag, Treatment Resistant Depression, ADHD, Cocaine Addiction, Sleepiness Associated With Opioid Analgesia, Lewy Body Dementia
Prescribing
FDA Schedule IV
Forms: 100, 200mg tablet
Dose Range: 200-800 mg/day
Starting: 200 mg qam is usual dose; max dose 800 mg daily
Stopping: Tapering unnecessary, though some patients may have sleepiness on discontinuation

NAMI drug fact sheet

Precautions
Contraindications: Not recommended for use in patients with a h/o LVH, ischemic ECG Δ's, chest pain, arrhythmias or recent MI
Serious Side Effects: Stevens-Johnson Syndrome
Side Effects: xerostomia, diarrhea, nausea, insomnia, anxiety, palpitations, rhinitis/rhinorrhea, hypertension, headache (34%)
Pharmacodynamics
1° MOA: Exact Mechanism Of Action Is Unknown, But It Is Believed That The Increase In Synaptic Dopamine Following Blockade Of DAT Leads To Increased Tonic Firing And Downstream Effects On Neurotransmitters Including Those Involved In Wakefulness, Such As Histamine And Orexin/ Hypocretin
Target: DAT, D2 partial agonist
Pharmacokinetics
t½: 15° TMAX: 2-4°
Substrate of: 3A4
Inhibits: 2C19; Induces: 3A4
Active Metabolites:
DDIs
Misc
  • - has as novel mechanism of action and therapeutic uses with less abuse potential, but is often classified as a stimulant
  • - binds at the DAT and is only about eightfold less potent than cocaine as a DAT inhibitor
  • - α1 antagonists (e.g., prazosin) may block its therapeutic actions
  • - may be useful in treating fatigue in patients with depression, multiple sclerosis, myotonic dystrophy and HIV/AIDS
  • - subjective sensation is generally normal wakefulness, not stimulation, but can occasionally include jitteriness
  • - may induce its own metabolism at high doses via 3A4 induction
Special Populations

Category Undefined.—Animal data suggest moderate risk, but limited human pregnancy experience prevents a full assessment of risk. Avoiding modafinil during pregnancy is the best course, but inadvertent exposure does not appear to represent a major risk of embryo-fetal harm

No reports describing the use of modafinil during human lactation have been located

Clearance of modafinil may be reduced in the elderly


There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment

Dose should be reduced in patients with severe hepatic impairment

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Last updated June 10 2018 15:40:14. Disclaimer: This website does not provide medical advice, nor is it a substitute for clinical judgment.