Provigil (modafinil) is a prescription-only wakefulness-promoting agent indicated for the management of excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD). It is a first-line treatment option that functions differently from traditional stimulants, offering a favorable side effect profile and a lower potential for abuse. By promoting alertness without significant euphoria, Provigil helps patients maintain normal wakefulness during desired hours, thereby improving functional outcomes and quality of life. Its mechanism of action involves selective activation of wake-promoting centers in the brain, specifically through interactions with dopamine, norepinephrine, and orexin/hypocretin systems.

Features

• Active ingredient: Modafinil
• Available in 100 mg and 200 mg oral tablets
• Schedule IV controlled substance in the United States
• Onset of action typically within 1–2 hours post-administration
• Half-life of approximately 12–15 hours
• Hepatic metabolism primarily via CYP3A4/5 enzymes
• Excretion mainly renal (≈80%) and fecal (≈10%)

Benefits

• Promotes sustained wakefulness and reduces excessive daytime sleepiness
• Improves cognitive function, including attention, memory, and executive functioning
• Enhances quality of life by enabling normal daily and occupational activities
• Lower abuse potential compared to amphetamine-based stimulants
• Minimal impact on normal sleep architecture when taken as directed
• May improve mood and motivation in certain patient populations

Common use

Provigil is FDA-approved for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea (with continued primary treatment such as CPAP), and shift work sleep disorder. Off-label uses may include attention-deficit/hyperactivity disorder (ADHD), fatigue associated with multiple sclerosis, and cognitive enhancement, though these applications lack full regulatory approval and require careful clinical consideration. It is not indicated for general fatigue or sleep deprivation in healthy individuals.

Dosage and direction

The recommended dosage for narcolepsy or obstructive sleep apnea is 200 mg taken orally once daily in the morning. For shift work sleep disorder, 200 mg should be taken approximately one hour prior to the start of the work shift. Dosing may be initiated at 100 mg for patients with hepatic impairment, elderly patients, or those who are sensitive to stimulant effects. Tablets should be swallowed whole with water and may be taken with or without food. Dosage adjustments should be made under medical supervision based on efficacy and tolerability.

Precautions

Patients should be monitored for the emergence or worsening of psychiatric symptoms, including depression, anxiety, hallucinations, or mania. Cardiovascular status should be assessed in patients with a history of hypertension, angina, or recent myocardial infarction. Caution is advised in patients with a history of substance abuse. Provigil may reduce the efficacy of hormonal contraceptives; alternative or additional methods of contraception are recommended. Patients should avoid alcohol while taking modafinil due to unpredictable effects on alertness and cognition.

Contraindications

Provigil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil. It should not be used in patients with symptomatic ischemic heart disease, left ventricular hypertrophy, or mitral valve prolapse accompanied by clinical symptoms. Use is contraindicated in patients with a history of psychosis or severe anxiety disorders that may be exacerbated by stimulant therapy. Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of hypertensive crisis.

Possible side effect

Common adverse reactions (≥5%) include headache, nausea, nervousness, anxiety, insomnia, dizziness, and diarrhea. Less frequently reported effects include dry mouth, palpitations, hypertension, rash, and blurred vision. Serious but rare side effects may include Stevens-Johnson syndrome, angioedema, multiorgan hypersensitivity reactions, and psychiatric symptoms such as suicidal ideation. Most side effects are dose-dependent and often diminish with continued use or dosage adjustment.

Drug interaction

Provigil induces CYP3A4 and may reduce plasma concentrations of substrates such as cyclosporine, ethinyl estradiol, midazolam, and triazolam. It may inhibit CYP2C19, potentially increasing levels of drugs like diazepam, phenytoin, and propranolol. Concurrent use with other CNS stimulants may produce additive effects. MAOIs are contraindicated. Warfarin levels may be affected; frequent INR monitoring is recommended. Modafinil may decrease the efficacy of hormonal contraceptives.

Missed dose

If a dose is missed, it should be taken as soon as possible unless it is close to the next scheduled dose. Doubling the dose is not recommended. For shift work sleep disorder, if the dose is missed and the work shift has already begun, it may be preferable to skip the dose to avoid interference with subsequent sleep.

Overdose

Symptoms of overdose may include insomnia, agitation, anxiety, confusion, tachycardia, hypertension, and gastrointestinal distress. In severe cases, hallucinations and psychotic symptoms may occur. There is no specific antidote; treatment is supportive and symptomatic. Cardiovascular monitoring is advised. Gastric lavage may be considered if ingestion was recent. Hemodialysis is not expected to be effective due to high protein binding.

Storage

Store at room temperature (20–25°C or 68–77°F) in a tightly closed container. Protect from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Dispose of unused medication through a drug take-back program or according to FDA-recommended guidelines.

Disclaimer

This information is intended for educational purposes only and does not constitute medical advice. Provigil is a prescription medication and should only be used under the supervision of a qualified healthcare provider. Individual response to therapy may vary. Patients should discuss their medical history, potential risks, and benefits with their prescribing physician. Never share medication with others or use it for unapproved indications.

Reviews

Clinical studies and patient reports generally indicate high satisfaction with Provigil for its intended indications. Many users report significant improvements in daytime alertness, cognitive function, and overall quality of life. Some note mild side effects during the initial adjustment period, though these often subside. Efficacy appears sustained with long-term use when prescribed appropriately. Healthcare providers emphasize the importance of proper diagnosis, patient selection, and ongoing monitoring to optimize outcomes and minimize risks.