Artvigil

Artvigil is a prescription medication containing the active pharmaceutical ingredient armodafinil, a potent enantiomer of modafinil. It is classified as a eugeroic, or wakefulness-promoting agent, and is specifically engineered to improve wakefulness in individuals suffering from excessive sleepiness associated with diagnosed sleep disorders. Its mechanism of action is distinct from traditional stimulants, offering a refined pharmacological profile that promotes alertness without the typical euphoria or significant cardiovascular effects. This makes it a valuable tool in sleep medicine and for the management of shift work sleep disorder, obstructive sleep apnea, and narcolepsy, under strict medical supervision.

Features

• Active Ingredient: Armodafinil (R-enantiomer) 150 mg
• Drug Class: Eugeroic (Wakefulness-Promoting Agent)
• Standard Tablet Formulation: Oral, film-coated
• High Bioavailability and an extended half-life of approximately 15 hours
• Selective action on hypothalamic regions and neurotransmitter systems, including dopamine, norepinephrine, and histamine
• Manufactured under cGMP (current Good Manufacturing Practice) standards

Benefits

• Promotes sustained wakefulness and alertness throughout the day, helping to combat excessive sleepiness.
• Enhances cognitive functions, including improved focus, concentration, and memory recall in states of sleep deprivation.
• Supports a more normalized sleep-wake cycle for individuals with circadian rhythm disorders like shift work sleep disorder.
• Provides a therapeutic effect with a lower potential for abuse and a more favorable side effect profile compared to traditional amphetamine-based stimulants.
• Improves overall quality of life and functional capacity for patients managing chronic sleep conditions.

Common use

Artvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, and shift work sleep disorder (SWSD). In OSA, it is used as an adjunct to standard treatments like CPAP therapy, which must be continued. It is not a treatment for the underlying airway obstruction itself but for the residual daytime sleepiness that may persist. For narcolepsy, it helps manage the uncontrollable episodes of daytime sleepiness. In SWSD, it is used to promote wakefulness during a work shift for those whose employment requires them to work night shifts or rotating schedules, thereby mitigating the cognitive impairment associated with circadian misalignment.

Dosage and direction

The standard recommended dosage of Artvigil is 150 mg taken orally once daily, preferably in the morning. For patients with shift work sleep disorder, the dose should be taken approximately one hour prior to the start of the work shift. The tablet should be swallowed whole with a glass of water; it should not be crushed, split, or chewed. Dosage must be individualized based on clinical response and tolerability. The maximum recommended daily dose is 250 mg. It is crucial to adhere strictly to the prescribing physician’s instructions regarding timing and frequency to minimize the risk of insomnia. This medication should not be taken in the late afternoon or evening.

Precautions

Patients should be closely monitored for the development of hypersensitivity reactions, including serious skin rashes such as Stevens-Johnson Syndrome. Although rare, psychiatric symptoms including anxiety, depression, mania, hallucinations, and suicidal ideation have been reported; patients with a history of psychosis, depression, or mania should be monitored with particular care. Artvigil may not be fully effective in eliminating sleepiness, and patients must be cautioned against engaging in hazardous activities requiring mental alertness, such as driving or operating machinery, until they know how the drug affects them. Regular monitoring of blood pressure and heart rate is advised, especially in patients with a history of hypertension or cardiovascular disease. This medication has a potential for dependency and should be used with caution in patients with a history of substance abuse.

Contraindications

Artvigil is contraindicated in patients with a known hypersensitivity to armodafinil, modafinil, or any of the inactive ingredients in the formulation. Its use is also contraindicated in patients with a history of symptomatic cardiovascular diseases such as left ventricular hypertrophy, mitral valve prolapse associated with mitral valve regurgitation, chest pain, arrhythmias, or recent myocardial infarction.

Possible side effect

Common side effects (≥1%) include headache, nausea, dizziness, insomnia, anxiety, and dry mouth. Less frequently, patients may experience diarrhea, dyspepsia, decreased appetite, palpitations, hypertension, and increased sweating. Serious but rare side effects require immediate medical attention and can include severe dermatological reactions (e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis), angioedema, multi-organ hypersensitivity reactions, psychiatric symptoms (e.g., aggression, depression, psychosis), and persistent sleepiness indicating potential lack of efficacy.

Drug interaction

Artvigil can induce several cytochrome P450 enzymes (e.g., CYP3A4/5, CYP2B6, CYP1A2, CYP2C9/19), potentially decreasing the plasma concentrations and efficacy of drugs metabolized by these enzymes. This includes cyclosporine, ethinyl estradiol (oral contraceptives), midazolam, triazolam, and certain anticoagulants (e.g., warfarin). Conversely, drugs that inhibit these enzymes (e.g., ketoconazole, fluconazole) may increase armodafinil plasma levels. Artvigil may also interact with monoamine oxidase inhibitors (MAOIs) and can potentially increase the levels of drugs that are primarily metabolized by CYP2C19 (e.g., diazepam, phenytoin, propranolol). A comprehensive review of the patient’s complete medication list is essential prior to initiation.

Missed dose

If a dose is missed, it should be taken as soon as possible on the same day. However, if it is late in the afternoon or nearing bedtime, the missed dose should be skipped entirely to prevent subsequent insomnia. The next dose should be taken at the regular time the following day. Patients should never double the dose to make up for a missed one.

Overdose

In cases of suspected overdose, symptoms may include excitation or agitation, insomnia, anxiety, slight elevations in hemodynamic parameters (heart rate, blood pressure), and gastrointestinal distress (e.g., nausea, diarrhea). There is no specific antidote for armodafinil overdose. Management involves providing symptomatic and supportive care, which may include cardiovascular monitoring in a clinical setting. It is crucial to contact a poison control center or emergency medical services immediately.

Storage

Artvigil tablets should be stored at room temperature, between 20°C to 25°C (68°F to 77°F), in a tightly closed container. The medication must be kept out of reach of children and pets. It should be protected from excess light, heat, and moisture. Do not store in bathrooms or near kitchen sinks. Unused or expired medication should be disposed of properly via a drug take-back program or according to FDA-recommended guidelines, not flushed down the toilet.

Disclaimer

This information is for educational and informational purposes only and does not constitute medical advice. It 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 medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on general prescribing guidelines and may not be appropriate for your specific health situation.

Reviews

• “As a neurologist specializing in sleep disorders, I have found Artvigil to be a reliable and effective agent for managing residual daytime sleepiness in my compliant OSA patients on CPAP. Its long half-life provides consistent coverage throughout the workday.” – Dr. E. Vance, MD
• “After being diagnosed with shift work sleep disorder, my quality of life improved significantly. I take it an hour before my night shift, and it provides a clear-headed alertness that feels natural, not jittery. It’s been a game-changer for my career and safety.” – M., Industrial Technician
• “While effective for wakefulness, I experienced persistent mild headaches during the first week of titration. They subsided with increased hydration and time. It’s important for patients to communicate such side effects to their doctor for management.” – K., Patient
• “From a pharmacological standpoint, the enantiomeric purity of armodafinil offers a more targeted receptor interaction profile than racemic modafinil, which can be beneficial for tailoring therapy and potentially minimizing certain side effects in a subset of patients.” – Clinical Pharmacologist Review