Provigil (modafinil) is a prescription-only wakefulness-promoting agent indicated for the improvement of wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD). It is classified as a Schedule IV controlled substance due to its potential for dependence. Unlike traditional stimulants, its precise mechanism of action is not fully understood but is believed to involve selective activation of wake-promoting centers in the brain, particularly through modulation of dopamine, norepinephrine, histamine, and orexin systems. It is not a replacement for treating the underlying causes of sleep disorders, such as using CPAP therapy for OSA, but serves as an adjunctive therapy to manage residual daytime sleepiness.

Features

• Active Ingredient: Modafinil
• Available Strengths: 100 mg and 200 mg tablets
• Classification: Central nervous system (CNS) stimulant, Schedule IV controlled substance
• Onset of Action: Typically within 1–2 hours post-administration
• Duration of Effect: Up to 12–15 hours
• Bioavailability: Approximately 80% following oral administration
• Metabolism: Primarily hepatic, via CYP3A4/5 and other enzymes
• Excretion: Renal (major) and fecal (minor)
• Manufacturer: Cephalon, Inc. (now part of Teva Pharmaceuticals)

Benefits

• Promotes sustained wakefulness and alertness in individuals with diagnosed sleep disorders.
• Helps improve cognitive function, including attention, memory, and executive functioning, in indicated populations.
• Reduces the frequency of unintended sleep episodes during waking hours.
• May enhance quality of life by allowing for greater daytime productivity and social engagement.
• Lower abuse potential compared to traditional amphetamine-based stimulants.
• Generally well-tolerated with a favorable side effect profile for many patients.

Common use

Provigil is FDA-approved for the treatment of excessive sleepiness associated with:

• Narcolepsy: A chronic neurological disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep.
• Obstructive Sleep Apnea (OSA): As adjunctive therapy to standard treatment (e.g., continuous positive airway pressure, or CPAP) for residual daytime sleepiness.
• Shift Work Sleep Disorder (SWSD): For individuals who experience insomnia during scheduled sleep periods or excessive sleepiness during scheduled wake periods due to work schedules.

Off-label uses, which are not FDA-approved and should only be considered under strict medical supervision, may include attention-deficit/hyperactivity disorder (ADHD), fatigue associated with multiple sclerosis, and depression-related fatigue.

Dosage and direction

The recommended dosage for Provigil must be individualized based on the condition being treated, patient response, and concomitant medical factors.

• For narcolepsy or OSA: The typical dose is 200 mg taken orally once daily in the morning.
• For shift work sleep disorder: 200 mg taken orally approximately 1 hour prior to the start of the work shift.

Dosage may be initiated at 100 mg for patients who are elderly, have severe hepatic impairment, or are sensitive to stimulants. Tablets should be swallowed whole with water; they may be taken with or without food, though food may delay absorption. Do not crush or chew tablets.

Dosage should not exceed 200 mg per day for SWSD and 400 mg per day for narcolepsy or OSA, though higher doses are not recommended and have not been shown to provide additional benefit.

Precautions

• Provigil may cause dizziness, blurred vision, or impaired judgment. Patients should avoid driving or operating machinery until they know how the medication affects them.
• Use with caution in patients with a history of psychosis, depression, mania, or cardiovascular disease. Monitoring of blood pressure and heart rate is advised.
• There is a potential for Provigil to reduce the effectiveness of hormonal contraceptives (e.g., birth control pills). Alternative or additional methods of contraception should be used during and for one month after discontinuation of therapy.
• Abrupt discontinuation should be avoided; tapering may be necessary in some cases to avoid withdrawal symptoms.
• Not recommended for use in pediatric patients. Safety and efficacy in children under 17 have not been established.
• Use during pregnancy only if clearly needed; modafinil is Pregnancy Category C. Discuss risks with a healthcare provider.

Contraindications

Provigil is contraindicated in patients with:

• Hypersensitivity to modafinil, armodafinil, or any component of the formulation.
• History of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia, or other clinically significant cardiac conditions without thorough cardiovascular evaluation.
• Patients with a history of drug abuse, due to its potential for psychological dependence (though lower than traditional stimulants).

Possible side effect

Common side effects (≥1%) may include:

• Headache
• Nausea
• Nervousness
• Anxiety
• Insomnia
• Dizziness
• Diarrhea
• Dry mouth

Less common but serious side effects requiring medical attention:

• Severe skin reactions (e.g., Stevens-Johnson syndrome)
• Psychiatric symptoms (e.g., aggression, depression, hallucinations)
• Chest pain, palpitations, or increased blood pressure
• Signs of allergic reaction (e.g., rash, itching, swelling)

Drug interaction

Provigil is a moderate inducer of CYP3A4 and may inhibit CYP2C19. It may interact with:

• Hormonal contraceptives: Reduced efficacy.
• Cyclosporine, warfarin, diazepam, phenytoin: Altered levels; monitoring recommended.
• CYP3A4 substrates/inhibitors/inducers: Potential for altered modafinil concentrations (e.g., ketoconazole may increase modafinil levels).
• Monoamine oxidase inhibitors (MAOIs): Should not be used concomitantly.

Always inform your healthcare provider of all medications, supplements, and herbal products you are taking.

Missed dose

If a dose is missed, take it as soon as remembered unless it is close to the time of the next dose. Do not double the dose to make up for a missed one. For shift work disorder, if missed before a shift, it may be taken later but may interfere with sleep after the shift.

Overdose

Symptoms of overdose may include:

• Agitation
• Insomnia
• Increased heart rate
• Hypertension
• Anxiety
• Confusion

In case of suspected overdose, seek immediate medical attention or contact a poison control center. Treatment is symptomatic and supportive; no specific antidote is available.

Storage

Store at room temperature (20–25°C or 68–77°F). Keep in the original container, tightly closed, and away from light, moisture, and heat. Keep out of reach of children and pets. Do not use after the expiration date.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Do not disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

Clinical studies and patient reports generally indicate:

• “Significant improvement in daytime alertness and reduction in sleep attacks for narcolepsy patients.”
• “Effective adjunct for residual sleepiness in OSA patients compliant with CPAP.”
• “Useful for managing sleep-wake cycle disruptions in shift workers, though some report insomnia if taken too late.”
• “Generally well-tolerated, though headaches and nausea are common initial side effects.”
• “Noted cognitive benefits in some off-label uses, though not FDA-approved for such indications.”

Individual experiences may vary. Always follow your prescriber’s guidance.