Vilafinil is a prescription medication containing modafinil, a wakefulness-promoting agent indicated for the treatment of excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. As a non-amphetamine central nervous system stimulant, it offers a favorable side effect profile while promoting sustained alertness and cognitive enhancement. Its mechanism of action involves selective activation of orexin/hypocretin neurons and modulation of dopamine, norepinephrine, and histamine pathways, distinguishing it from traditional stimulants. Vilafinil is recognized for its ability to improve executive function, memory consolidation, and mental acuity without the euphoric highs or severe crashes associated with older-generation stimulants.

Features

• Active ingredient: Modafinil 200 mg
• Pharmacologic class: Eugeroic (wakefulness-promoting agent)
• Onset of action: Within 1–2 hours post-administration
• Duration of effect: Up to 12–15 hours
• Bioavailability: Approximately 80%
• Half-life: 12–15 hours
• Metabolism: Hepatic, primarily via CYP3A4/5
• Excretion: Renal (90%) and fecal (10%)
• Formulation: Oral tablet
• Prescription status: Schedule IV controlled substance (US)

Benefits

• Promotes sustained wakefulness and reduces excessive daytime sleepiness without significant peripheral stimulation
• Enhances cognitive functions including working memory, attention, and executive decision-making
• Improves quality of life for individuals with sleep disorders by restoring normal wake-sleep cycles
• Low abuse potential compared to amphetamine-based stimulants
• Minimal impact on cardiovascular parameters at therapeutic doses
• Does not typically interfere with normal sleep architecture when dosed appropriately

Common use

Vilafinil is primarily prescribed for the management of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD). Off-label applications include adjunct treatment for attention deficit hyperactivity disorder (ADHD), fatigue associated with multiple sclerosis, and cognitive enhancement in treatment-resistant depression. It is particularly valuable for professionals requiring sustained mental alertness during extended work hours, though such use must be medically supervised. Clinical studies demonstrate significant improvement in Epworth Sleepiness Scale scores and maintenance of wakefulness test performance.

Dosage and direction

The recommended dosage for most adults is 200 mg taken orally once daily, preferably in the morning. For shift work sleep disorder, take approximately 1 hour before the work shift begins. Dosage adjustment may be necessary for elderly patients or those with severe hepatic impairment—typically reduced to 100 mg daily. Tablets should be swallowed whole with water and may be taken with or without food, though high-fat meals may delay absorption. Do not crush or chew tablets. Dosage should not exceed 400 mg daily under any circumstances. Treatment should begin at the lowest effective dose and be periodically reevaluated for continued necessity.

Precautions

Patients should undergo comprehensive cardiovascular evaluation before initiation, particularly those with left ventricular hypertrophy or mitral valve prolapse. Monitor blood pressure regularly during treatment. Use with caution in patients with history of psychosis, depression, or mania, as Vilafinil may unmask underlying psychiatric conditions. Hepatic function should be assessed periodically during long-term therapy. Patients should be advised that Vilafinil is not a replacement for adequate sleep and proper sleep hygiene practices. Caution should be exercised when operating machinery or driving until individual response is established. Abrupt discontinuation after prolonged use may result in withdrawal symptoms including fatigue and depression.

Contraindications

Vilafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil. Absolute contraindications include severe uncontrolled hypertension, symptomatic cardiovascular disease, recent myocardial infarction, and history of cardiac arrhythmias. Should not be used during pregnancy (Category C) unless potential benefits outweigh risks. Contraindicated in patients with history of drug abuse and those taking monoamine oxidase inhibitors (MAOIs). Not recommended for patients with severe hepatic impairment (Child-Pugh Class C) without dosage adjustment and close monitoring.

Possible side effect

Common side effects (≥5% incidence) include headache (34%), nausea (11%), nervousness (7%), insomnia (5%), and dizziness (5%). Less frequent adverse reactions (1–5%) include dry mouth, anxiety, diarrhea, dyspepsia, and rhinitis. Serious but rare side effects (<1%) include Stevens-Johnson syndrome, angioedema, multiorgan hypersensitivity reactions, and psychiatric symptoms such as aggression, hallucinations, or suicidal ideation. Most side effects are dose-dependent and tend to diminish with continued therapy. Patients should report any persistent or severe reactions immediately to their healthcare provider.

Drug interaction

Vilafinil exhibits complex pharmacokinetic interactions as both substrate and inducer of CYP enzymes. It may decrease concentrations of cyclosporine, ethinyl estradiol, triazolam, midazolam, and certain anticonvulsants. Concurrent use with CYP3A4 inhibitors (ketoconazole, erythromycin) may increase modafinil levels. May reduce efficacy of hormonal contraceptives—alternative non-hormonal contraception recommended. Potentiates effects of other CNS stimulants and sympathomimetics. Use with MAOIs may precipitate hypertensive crisis. May interfere with metabolism of warfarin, requiring more frequent INR monitoring. Always provide complete medication list to prescribing physician.

Missed dose

If a dose is missed, take it as soon as remembered unless it is approaching the evening hours. Do not double the dose to make up for a missed administration. Taking Vilafinil too late in the day may cause insomnia and disrupt normal sleep patterns. If next dose is due within 8 hours, skip the missed dose and resume regular schedule. Maintain consistent dosing timing to ensure stable therapeutic effects and minimize sleep disturbances.

Overdose

Symptoms of overdose may include insomnia, central nervous system excitation, agitation, anxiety, confusion, tachycardia, hypertension, and gastrointestinal distress. In severe cases, hallucinations and psychotic symptoms may occur. There is no specific antidote for modafinil overdose. Treatment is supportive and symptomatic, including cardiac monitoring and management of hypertension if present. Gastric lavage may be considered if presentation is early after ingestion. Activated charcoal may be administered. Hemodialysis is not effective due to high protein binding. Contact poison control center immediately for guidance.

Storage

Store at controlled room temperature (20–25°C or 68–77°F) in original container. Protect from light and moisture. Keep tightly closed and out of reach of children and pets. Do not store in bathroom or other areas with high humidity. Discard any medication that has expired or shows signs of deterioration. Do not flush medications down toilet—dispose through proper medication take-back programs or according to FDA guidelines.

Disclaimer

This information is for educational purposes only and does not constitute medical advice. Vilafinil is a prescription medication that should only be used under direct medical supervision. Individual response may vary, and not all patients will experience the described benefits. This document does not replace comprehensive professional medical consultation, diagnosis, or treatment. Always seek the advice of your physician or qualified healthcare provider with any questions regarding medical conditions or medication use. Never disregard professional medical advice or delay seeking it because of information contained herein.

Reviews

Clinical studies demonstrate 68–85% of patients report significant improvement in daytime sleepiness measures. In a 12-week randomized controlled trial, 78% of narcolepsy patients achieved normalized sleep latency compared to 23% placebo. Shift workers report 40% improvement in attention tasks during night shifts. Long-term safety data shows maintained efficacy over 12 months with consistent side effect profile. Patient satisfaction surveys indicate high continuation rates due to improved quality of life and minimal disruption to normal activities. Healthcare providers note particular value in patients who cannot tolerate traditional stimulants.