Medication Guide for Provigil

Generic Name

Modafinil

Brand Name

Provigil

Class of Medication

CNS Stimulant

Forms Available

Tablets

Strengths Available

100 mg, 200 mg

Mechanism of Action

Modulates brain chemicals to promote wakefulness.

Primary Uses

Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder

Secondary Uses

Off-label uses include ADHD, depression, and fatigue in multiple sclerosis.

Dosage Instructions

For narcolepsy and OSA: 200 mg once daily in the morning. For shift work disorder: 200 mg approximately one hour before work shift. Maximum dose: 400 mg daily.

Administration Guidelines

Take with or without food, usually in the morning. Swallow tablet whole; do not crush or chew.

Storage Recommendations

Store at room temperature, away from moisture, heat, and light.

Missed Dose Instructions

If you miss a dose, take it as soon as possible. If it’s close to the next dose, skip the missed dose. Do not double up to catch up.

Common Side Effects

Headache, nausea, nervousness, dizziness, difficulty sleeping.

Interactions with Medications

Can interact with birth control pills, anticoagulants such as warfarin, and medications causing high blood pressure.

Alcohol Interaction

Use caution with alcohol; may increase the risk of side effects.

Pregnancy Category

Category C: Risk cannot be ruled out. Consult healthcare provider.

Breastfeeding Considerations

Not recommended unless absolutely necessary. Modafinil excretion in breast milk is unknown.

Contraindications

Known hypersensitivity to modafinil or armodafinil. History of left ventricular hypertrophy or mitral valve prolapse with previous CNS stimulant use.

Monitoring Requirements

Regularly monitor blood pressure, heart rate, and mental state.

Instructions for Health Professionals

Assess patient throughout treatment for signs of misuse or abuse. Consider monitoring liver function tests periodically.

Adjustment for Renal Impairment

No specific dosage adjustment required for mild-to-moderate renal impairment. Monitor for side effects.

Adjustment for Hepatic Impairment

Reduce dosage in moderate to severe hepatic impairment. Maximum recommended dose is 100 mg.

Geriatric Use

Increased sensitivity; consider lower initial dose of 100 mg/day.

Pediatric Use

Safety and efficacy not established for individuals under 17 years of age.

Overdose Management

Supportive measures and symptomatic treatment. Activated charcoal may help if taken soon after ingestion.

Drug Tolerance

Long-term use may lead to drug tolerance. Monitor efficacy overtime.

Dependence and Abuse

Possible risk of abuse; monitor patients for signs of misuse. Schedule IV controlled substance.

Psychiatric Reactions

Possibility of psychiatric adverse reactions such as agitation, hallucinations, and mania. Consider discontinuing if severe manifestations occur.

Withdrawal Symptoms

Potential for withdrawal symptoms if discontinued abruptly after prolonged use. Gradual dose reduction recommended.

Animal Studies

Animal studies suggest potential for embryo-fetal toxicity; relevance to humans uncertain.

Photosensitivity

Has been reported in some cases; advise patients to use sun protection.

Extra Care in Pilot Use

Pilots and other similar professions should note modafinil use can be subject to strict regulations.

External Interaction Risks

Modafinil may interfere with lab tests for blood levels and liver function.

Effect on Drive/Operate Machinery

May impact ability to perform tasks requiring complete mental alertness; use caution.

Patient Information Leaflet

Provision of a patient information leaflet is recommended for understanding precautions and drug specifics.