modafinil

Adjunctive therapy

Brands: Provigil

Last reviewed 2025-12-30

Reviewed by PsychMed Editorial Team.

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Quick answers

What is modafinil?
Modafinil (brand Provigil) is a wakefulness-promoting medication indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD) (label).
What is Provigil?
Provigil is a brand name for modafinil.
What is Provigil (modafinil) used for?
Label indications include: Improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, or shift work disorder (label).
What drug class is Provigil (modafinil)?
Wakefulness-promoting agent used for excessive sleepiness in narcolepsy, obstructive sleep apnea, and shift work disorder; Schedule IV with important rash/hypersensitivity warnings and clinically relevant CYP3A4 induction and CYP2C19 inhibition interactions.
What strengths does Provigil (modafinil) come in?
Tablets: 100 mg and 200 mg (label).

Snapshot

Class: Adjunctive therapy
Common US brands: Provigil
Therapeutic drug monitoring not routinely recommended.
Last reviewed: 2025-12-30

Label indications

Improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, or shift work disorder (label).

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Clinical Highlights

Modafinil (brand Provigil) is a wakefulness-promoting medication indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD) (label). It is a Schedule IV controlled substance. In psychiatric settings it is sometimes discussed as off-label augmentation for fatigue and residual sleepiness, but use is individualized and requires careful monitoring (clinical).

A rare but safety-critical risk is serious rash (including Stevens-Johnson syndrome) and other hypersensitivity reactions; discontinuation is recommended at the first sign of rash unless clearly not drug-related (label).
Modafinil can affect hormonal contraception efficacy via CYP3A induction; alternative or concomitant contraception is recommended during therapy and for one month after discontinuation (label).
The compare view, modafinil evidence feed, and modafinil print page help compare activation, insomnia, and interaction profiles.

Dosing & Formulations

Tablets: 100 mg and 200 mg (label). Narcolepsy or OSA: 200 mg once daily in the morning (label).

Shift work disorder: 200 mg once daily taken approximately 1 hour prior to the start of the work shift (label).
Doses up to 400 mg/day have been tolerated in studies, but the label notes no consistent evidence of added benefit beyond 200 mg/day (label).
For OSA, modafinil is not a substitute for primary treatments (e.g., CPAP adherence); clinicians often document ongoing OSA management when used (label/clinical).

Monitoring & Risks

Serious rash/hypersensitivity is the key “must not miss” safety issue; most serious cases occurred within 1–5 weeks, but timing is not fully predictive (label). Psychiatric effects (anxiety, agitation, mania, psychosis) have been reported; monitoring is especially important in bipolar-spectrum illness or active psychosis (label/clinical).

Insomnia can occur; morning dosing and avoiding late-day use are common practical strategies (clinical).
Cardiovascular monitoring is commonly considered in patients with uncontrolled hypertension, arrhythmia history, or other risk factors, particularly when combined with stimulants (clinical).
Modafinil is not approved for pediatric use, and rash risk in pediatric trials contributed to this restriction (label).

Drug Interactions

CYP3A4/5 induction can reduce exposure to substrates such as steroidal contraceptives, cyclosporine, midazolam, and triazolam; clinical monitoring and dose adjustments may be required (label). CYP2C19 inhibition can increase exposure to substrates such as diazepam, propranolol, omeprazole, and some tricyclic antidepressants; interaction review is important in polypharmacy (label/clinical).

In CYP2D6 poor metabolizers, CYP2C19 becomes a more important pathway for certain drugs, so modafinil’s CYP2C19 effects may be amplified in some patients (label).

Practice Notes

In psychiatric use, clinicians often document the symptom target (excessive sleepiness vs fatigue) and reassess benefit and sleep disruption after a time-limited trial (clinical). When insomnia or anxiety worsens, medication timing, dose reduction, or alternative strategies are commonly considered rather than escalating dose (clinical).

Interaction counseling (especially contraception) is an important part of safe prescribing (label/clinical).

References

PROVIGIL (modafinil) tablets prescribing information — DailyMed (2025)
Modafinil Augmentation Therapy IN Unipolar AND Bipolar Depression: A Systematic Review AND Meta Analysis OF Randomized Controlled Trials — Journal of Clinical Psychiatry (2013)
AGNP Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology — Pharmacopsychiatry (2018)