Provigil (modafinil) is a prescription medication indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work sleep disorder (SWSD). As a central nervous system stimulant with a unique mechanism of action, it promotes alertness without the typical amphetamine-like side effects, making it a valuable tool in managing sleep-related disorders. This product card provides a comprehensive overview for healthcare professionals to ensure informed and safe prescribing practices.

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 15 hours
• Hepatic metabolism primarily via CYP3A4/5 enzymes
• Excretion primarily renal (≈80%) and fecal (≈10%)

Benefits

• Promotes sustained wakefulness and reduces excessive daytime sleepiness in narcolepsy patients.
• Improves alertness and cognitive performance in individuals with shift work sleep disorder.
• Serves as adjunct therapy to continuous positive airway pressure (CPAP) in obstructive sleep apnea.
• Exhibits a favorable side effect profile compared to traditional stimulants.
• Enhances executive function, attention, and working memory in clinical settings.
• Supports improved quality of life by enabling normal daily activities despite sleep disorders.

Common use

Provigil is primarily prescribed for the treatment of excessive sleepiness associated with diagnosed medical conditions: narcolepsy, obstructive sleep apnea (as an adjunct to standard treatments like CPAP), and shift work sleep disorder. It is used off-label in some cases for attention deficit hyperactivity disorder (ADHD) and fatigue related to medical conditions such as multiple sclerosis, though these uses are not FDA-approved and require careful clinical judgment.

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 is taken approximately one hour prior to the start of the work shift. Dosing may be adjusted based on efficacy and tolerability, with some patients responding to 100 mg daily. Tablets should be swallowed whole with water; they may be taken with or without food, though food may delay absorption. Dosage adjustments are necessary in patients with severe hepatic impairment, with a recommended dose of 100 mg daily.

Precautions

• Use with caution in patients with a history of cardiovascular disease, including left ventricular hypertrophy, mitral valve prolapse, or recent myocardial infarction, as increases in blood pressure and heart rate may occur.
• Monitor for signs of psychiatric symptoms such as anxiety, mania, hallucinations, or suicidal ideation, especially in patients with a history of psychiatric disorders.
• Evaluate patients for undiagnosed sleep disorders before initiation, as underlying causes of sleepiness should be addressed.
• Avoid use in patients with a history of substance abuse due to potential for dependence, though risk is lower than with amphetamines.
• Periodic monitoring of blood pressure and heart rate is advised during treatment.
• Use during pregnancy only if clearly needed, as animal studies showed developmental toxicity; adequate contraception is recommended in women of childbearing potential.

Contraindications

• Hypersensitivity to modafinil, armodafinil, or any component of the formulation.
• History of allergic reactions or serious skin rashes, such as Stevens-Johnson syndrome, to modafinil.
• Use in patients with significant uncontrolled hypertension or symptomatic cardiovascular disease without careful risk-benefit assessment.
• Not recommended in patients with severe hepatic impairment without dosage adjustment and close monitoring.

Possible side effect

Common adverse reactions (≥5% and greater than placebo) include headache, nausea, nervousness, anxiety, insomnia, dizziness, and diarrhea. Less frequently, dry mouth, constipation, and palpitations may occur. Serious but rare side effects include severe skin reactions (e.g., Stevens-Johnson syndrome), angioedema, multiorgan hypersensitivity reactions, psychiatric symptoms (e.g., aggression, depression, psychosis), and cardiovascular events like increased blood pressure or tachycardia. Patients should be advised to report any unusual or severe symptoms promptly.

Drug interaction

• Strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, rifampin) may decrease modafinil concentrations, reducing efficacy.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase modafinil levels, raising the risk of adverse effects.
• Modafinil is a weak inducer of CYP3A4 and may reduce the efficacy of hormonal contraceptives, cyclosporine, and certain antifungals or antiepileptics.
• It may increase concentrations of drugs metabolized by CYP2C19 (e.g., diazepam, phenytoin, propranolol).
• Use with other CNS stimulants or monoamine oxidase inhibitors (MAOIs) may potentiate sympathetic effects and is not recommended.
• Caution is advised with warfarin, as modafinil may increase its plasma levels and require INR monitoring.

Missed dose

If a dose is missed, it should be taken as soon as possible on the same day. However, if it is nearing the time for the next scheduled dose, the missed dose should be skipped to avoid double dosing and potential sleep disruption. Patients should not take extra tablets to make up for a missed dose. Consistency in daily timing is recommended to maintain stable therapeutic effects.

Overdose

Symptoms of overdose may include insomnia, agitation, anxiety, confusion, nausea, diarrhea, tachycardia, hypertension, and in severe cases, hallucinations or cardiovascular effects. There is no specific antidote; management involves symptomatic and supportive care, including cardiac monitoring and vital sign support. Gastric lavage or activated charcoal may be considered if ingestion was recent. Patients suspected of overdose should seek immediate medical attention.

Storage

Store at room temperature, 20–25°C (68–77°F), in a tightly closed container, away from light, moisture, and heat. Keep out of reach of children and pets. Do not flush medications down the toilet or pour into drains unless instructed to do so. Proper disposal through a medicine take-back program is recommended to prevent misuse.

Disclaimer

This information is intended for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition or medication. Do not disregard professional medical advice or delay in seeking it because of something you have read here. The prescribing physician should be consulted for personalized recommendations based on the patient’s specific health status and needs.

Reviews

Clinical studies and post-marketing surveillance indicate that Provigil is generally well-tolerated and effective in promoting wakefulness. In randomized controlled trials, patients with narcolepsy showed significant improvement in sleep latency tests compared to placebo. Shift workers reported enhanced alertness and reduced sleepiness during night shifts. Some users note mild side effects like headache or nausea, which often subside with continued use. Long-term use data support its efficacy, though individual responses may vary. Healthcare providers emphasize the importance of adherence to prescribed dosing and regular follow-up to monitor efficacy and safety.