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). Its unique mechanism of action, distinct from traditional stimulants, offers a targeted approach to managing pathological sleepiness. This medication is classified as a Schedule IV controlled substance due to its potential for dependence and is intended for use under strict medical supervision as part of a comprehensive treatment plan that may include other interventions like behavioral therapy or CPAP for OSA.

Features

• Active Ingredient: Modafinil
• Available Strengths: 100 mg and 200 mg tablets
• Mechanism of Action: Exact mechanism unknown; believed to work by increasing dopamine in the brain by inhibiting dopamine reuptake. It may also affect other neurotransmitters like norepinephrine, serotonin, and histamine.
• Onset of Action: Typically within 1–2 hours post-administration
• Duration of Effect: Up to 12–15 hours
• Bioavailability: High, with peak plasma concentrations occurring at approximately 2–4 hours
• Half-life: 12–15 hours
• Metabolism: Primarily hepatic, via CYP3A4/5 and other enzymes
• Excretion: Mainly renal (as metabolites)

Benefits

• Promotes sustained wakefulness and alertness during waking hours, allowing for improved daytime functioning.
• Reduces the frequency of cataplexy attacks in patients with narcolepsy.
• Helps mitigate extreme sleepiness in shift workers, enhancing safety and job performance.
• Improves cognitive functions such as memory, attention, and executive function in individuals with sleep disorders.
• Does not generally produce the euphoric highs or severe crashes associated with traditional stimulants like amphetamines.
• May contribute to an improved quality of life by enabling greater participation in daily and professional activities.

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 treatments like continuous positive airway pressure (CPAP) for residual sleepiness.
• Shift Work Sleep Disorder (SWSD): For those who experience insomnia during scheduled sleep periods or excessive sleepiness during scheduled wake periods.

Off-label, it is sometimes used under specialist supervision for conditions like attention-deficit/hyperactivity disorder (ADHD), fatigue associated with multiple sclerosis, and depression-related fatigue, though these uses are not officially approved.

Dosage and direction

Dosage must be individualized based on the condition being treated and patient response.

• Narcolepsy or OSA: The recommended dose is 200 mg taken orally once daily in the morning.
• Shift Work Sleep Disorder: 200 mg taken orally approximately 1 hour prior to the start of the work shift.
• Administration with or without food is acceptable, though taking with food may delay absorption.
• For patients with severe hepatic impairment, a reduced dose of 100 mg daily is recommended.
• Not recommended for use in patients with severe renal impairment.
• The total daily dose should not exceed 200 mg for SWSD and OSA; for narcolepsy, some patients may benefit from a morning dose of 200 mg and a noon dose of 200 mg, though this should be carefully evaluated by a physician.

Precautions

• May cause dizziness or blurred vision; patients should avoid driving or operating machinery until they know how Provigil affects them.
• Use with caution in patients with a history of psychosis, depression, mania, or cardiovascular disease.
• Not recommended for use in pediatric patients.
• May reduce the efficacy of hormonal contraceptives; alternative or additional non-hormonal methods of contraception should be used during and for one month after discontinuation of therapy.
• Monitor for signs of misuse, abuse, or dependence, especially in patients with a history of drug abuse.
• Periodic monitoring of blood pressure and heart rate is advised in patients with hypertension or cardiac conditions.

Contraindications

• Hypersensitivity to modafinil, armodafinil, or any component of the formulation.
• History of left ventricular hypertrophy or ischemic ECG changes, chest pain, or arrhythmia in association with prior stimulant use.
• Use in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome with prior CNS stimulant use.

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 such as depression, hallucinations, aggression, or suicidal ideation
• Symptoms of heart problems (chest pain, irregular heartbeat)
• Multiorgan hypersensitivity reactions

Drug interaction

Provigil is a moderate inducer of CYP3A4 and may also inhibit CYP2C19. Important interactions include:

• Hormonal Contraceptives: May reduce their effectiveness.
• Cyclosporine, Theophylline: May decrease their plasma concentrations.
• Warfarin: May alter anticoagulant effect; monitor INR closely.
• CYP2C19 Substrates (e.g., diazepam, phenytoin, propranolol): May increase their plasma levels.
• Monoamine Oxidase Inhibitors (MAOIs): Should not be used concurrently due to theoretical risk of hypertensive crisis.
• Other CNS Stimulants: May have additive effects.

Missed dose

If a dose is missed, it should be taken as soon as possible on the same day. However, if it is close to the time of the next dose, the missed dose should be skipped. Doubling the dose is not recommended. For shift work disorder, if the dose is missed and the work shift has already begun, it may be too late for that dose to be effective.

Overdose

Symptoms of overdose may include:

• Agitation
• Insomnia
• Anxiety
• Confusion
• Tachycardia
• Hypertension or hypotension
• Nausea and gastrointestinal distress

In case of suspected overdose, seek emergency medical attention immediately. Treatment is symptomatic and supportive; there is no specific antidote.

Storage

• Store at room temperature (20°C to 25°C or 68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
• Keep in the original container, tightly closed, and protect from light and moisture.
• Keep out of reach of children and pets.

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 treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. Provigil is a prescription medication and should only be used under the supervision of a licensed healthcare professional.

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 sleepiness associated with night shifts, though some report insomnia if taken too late.”
• “Generally well-tolerated, though headache and nausea are common initial side effects that often subside.”
• “Noted improvements in concentration and task persistence in some off-label uses, though evidence is mixed.”

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