Modafinil
PROVIGIL
What it isDopamine reuptake inhibitor and wake-promoting agent; narcolepsy, OSA-related sleepiness and shift-work disorder.
Why this oneIt promotes wakefulness with less sympathetic activation and lower abuse potential than amphetamine.
What limits itIt induces CYP3A4 enough to fail oral contraceptives, so alternative contraception is essential. Serious rash including SJS can occur.
FDA-approved for
- narcolepsy/shift-work/OSA sleepiness (1998)
Off-label
- depression-related fatigue
- ADHD
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Narcolepsy | Adult | 200 mg QAM | 400 mg QD (no consistent added benefit) | |
| Obstructive sleep apnea | Adult | 200 mg QAM | 400 mg QD (no consistent added benefit) | |
| Shift work disorder | Adult | 200 mg QD, ~1 h before shift |
Renal Undefined
Hepatic Reduce to one-half the recommended dose in severe hepatic impairment.
Instructions
- Consider lower dose and close monitoring in geriatric patients.
Cautions
- Serious rash including Stevens-Johnson syndrome, TEN, DRESS
- Angioedema and anaphylaxis
- Multi-organ hypersensitivity reactions
- Persistent sleepiness (caution driving)
- Psychiatric symptoms (use caution with psychosis, depression, mania)
- Cardiovascular events (avoid with LVH or mitral valve prolapse syndrome)
Adverse reactions
- Headache
- Nausea
- Nervousness
- Rhinitis
- Diarrhea
- Back pain
- Anxiety
- Insomnia
- Dizziness
- Dyspepsia
Pregnancy May cause fetal harm based on animal data; intrauterine growth restriction and spontaneous abortion reported.
Lactation Unknown whether excreted in human milk; exercise caution.
NO BOXED WARNINGS
Principal riskIt induces CYP3A4 enough to fail oral contraceptives
Cost, est. cash$5–$150/month
Generic entry2012
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilitySerious rash, psychiatric activation and CYP-mediated interactions; misuse potential is present.
Mechanism of action: Modafinil ballicule
Open Modafinil in the interactive console ↗
Memory aids: mascots and interaction avatars
