Modvigil is a prescription medication containing modafinil, a wakefulness-promoting agent indicated for the improvement of wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD). It is classified as a eugeroic, or wakefulness-promoting agent, and functions differently from traditional stimulants. This product card provides a detailed, expert-level overview of its features, benefits, and essential safety information for healthcare professionals and informed patients.

Features

• Active Ingredient: Modafinil (200 mg per tablet)
• Pharmacologic Class: Eugeroic (wakefulness-promoting agent)
• Mechanism of Action: Exact mechanism unknown; believed to involve dopamine reuptake inhibition and activation of hypothalamic wakefulness centers
• Bioavailability: Approximately 80% following oral administration
• Time to Peak Plasma Concentration: 2–4 hours
• Elimination Half-Life: 12–15 hours
• Dosage Form: Oral tablet
• Manufacturing Standards: Complies with current Good Manufacturing Practices (cGMP)

Benefits

• Promotes sustained wakefulness and alertness in individuals with diagnosed sleep disorders
• Helps improve daytime functioning and reduce episodes of unintended sleep in narcolepsy
• Aids in maintaining wakefulness during work hours for those with shift work sleep disorder
• May enhance cognitive functions such as memory, focus, and executive function in certain patient populations
• Offers a favorable side effect profile compared to traditional stimulants like amphetamines
• Supports improved quality of life by enabling greater participation in daily and professional activities

Common use

Modvigil is primarily prescribed 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 continuous positive airway pressure (CPAP) to resolve residual daytime sleepiness
• Shift Work Sleep Disorder (SWSD), for those who experience insomnia during scheduled sleep times or excessive sleepiness during scheduled wake times

Off-label uses may include the management of fatigue in conditions such as multiple sclerosis or Parkinson’s disease, and as cognitive enhancement in certain contexts, though these are not FDA-approved indications.

Dosage and direction

The recommended dosage for Modvigil is 200 mg taken orally once daily.

• For narcolepsy or OSA: 200 mg taken in the morning.
• For shift work sleep disorder: 200 mg taken approximately one hour before the start of the work shift.
• Dosage may be adjusted based on individual response and tolerability, under medical supervision.
• 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.

Precautions

• Use with caution in patients with a history of cardiovascular disease, including left ventricular hypertrophy, mitral valve prolapse, or recent myocardial infarction.
• Monitor patients for the emergence or worsening of psychiatric symptoms such as depression, anxiety, or psychosis.
• May impair ability to engage in potentially hazardous activities, such as driving or operating machinery; advise patients until they know how Modvigil affects them.
• Not recommended during pregnancy unless potential benefits justify potential risks; advise women of childbearing potential to use effective contraception.
• Use with caution in patients with hepatic impairment; dosage adjustment may be necessary.
• Avoid use in patients with a history of drug abuse; potential for dependence exists, though lower than with traditional stimulants.

Contraindications

Modvigil is contraindicated in patients with:

• Hypersensitivity to modafinil, armodafinil, or any component of the formulation.
• History of symptomatic cardiovascular disease, including but not limited to coronary artery disease, angina, or arrhythmias.
• Severe hepatic impairment.
• History of psychosis or manic episodes.

Possible side effect

Common side effects may include:

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

Less common but serious side effects require immediate medical attention:

• Severe skin reactions (e.g., Stevens-Johnson syndrome)
• Psychiatric symptoms such as anxiety, depression, hallucinations, or suicidal ideation
• Signs of cardiovascular issues including chest pain, palpitations, or hypertension
• Symptoms of allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing

Drug interaction

Modvigil may interact with:

• CYP3A4/5 substrates (e.g., cyclosporine, ethinyl estradiol, midazolam): Modvigil may decrease their efficacy.
• CYP2C19 inhibitors (e.g., fluoxetine, omeprazole): May increase modafinil plasma concentrations.
• Warfarin: Altered anticoagulant effect; monitor INR closely.
• Monoamine oxidase inhibitors (MAOIs): Potential for hypertensive crisis; avoid concomitant use.
• CNS depressants (e.g., alcohol, benzodiazepines): Additive sedative effects may occur.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is close to the time of the next dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one.

Overdose

Symptoms of overdose may include:

• Agitation
• Insomnia
• Tachycardia
• Hypertension
• Anxiety
• Confusion

In case of suspected overdose, seek immediate medical attention or contact a poison control center. Treatment is symptomatic and supportive; ensure adequate hydration and monitor cardiac function.

Storage

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

Disclaimer

This information is intended for educational purposes and does not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting or changing any medication regimen. Do not disregard professional medical advice or delay seeking it based on information provided here.

Reviews

Clinical studies and patient reports indicate that Modvigil is effective in promoting wakefulness and improving alertness in individuals with sleep disorders. Many users report enhanced productivity and quality of life. However, experiences vary, and some individuals may not respond as expected or may experience side effects. Always follow your healthcare provider’s guidance regarding use.