Artvigil: Enhance Wakefulness and Cognitive Performance

Artvigil

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Product dosage: 150 mg
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Synonyms Nuvigil

Artvigil is a prescription medication containing armodafinil, the R-enantiomer of modafinil, designed to promote wakefulness in individuals with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD). As a eugeroic or wakefulness-promoting agent, it functions by altering the natural chemicals (neurotransmitters) in the brain area that controls sleep and wakefulness. Unlike traditional stimulants, it is not an amphetamine and has a lower potential for abuse, offering a refined approach to managing sleep-wake cycle disruptions. Its prolonged duration of action provides sustained alertness, making it a cornerstone in sleep medicine for improving daytime functioning.

Features

• Active Ingredient: Armodafinil (150 mg tablets)
• Pharmacological Class: Eugeroic (Wakefulness-Promoting Agent)
• Mechanism of Action: Precise modulation of dopamine, norepinephrine, histamine, and orexin neurotransmission
• Bioavailability: High oral bioavailability
• Time to Peak Plasma Concentration (Tmax): Approximately 2 hours in a fasted state
• Elimination Half-Life: ~15 hours, allowing for once-daily dosing
• Presentation: White to off-white, round, biconvex tablets

Benefits

• Promotes sustained wakefulness and alertness throughout the day, reducing the intrusion of sleep episodes.
• Enhances cognitive functions, including improved memory, focus, and executive function in patients with sleep disorders.
• Helps normalize the sleep-wake cycle for shift workers, improving adaptation to non-standard work hours.
• Reduces the residual excessive sleepiness often experienced by patients with OSA despite primary airway pressure therapy.
• Offers a favorable side effect profile with a lower risk of jitteriness and euphoria compared to traditional stimulants.
• Improves overall quality of life by enabling greater participation in daily professional, social, and personal activities.

Common use

Artvigil (armodafinil) is FDA-approved for the treatment of excessive sleepiness associated with three conditions:

1. Narcolepsy: A chronic neurological disorder characterized by the brain’s inability to regulate sleep-wake cycles normally, leading to overwhelming daytime drowsiness and sudden attacks of sleep.
2. Obstructive Sleep Apnea (OSA): Used as adjunctive therapy to standard treatment (e.g., continuous positive airway pressure, or CPAP) for patients who continue to experience excessive daytime sleepiness. It does not treat the underlying airway obstruction.
3. Shift Work Sleep Disorder (SWSD): For individuals who experience insomnia during scheduled sleep times or excessive sleepiness during scheduled wake times due to a work schedule that overlaps with the typical sleep period.

Its use is strictly on a prescription basis following a comprehensive medical evaluation and diagnosis by a qualified healthcare professional.

Dosage and direction

The dosage of Artvigil must be individualized based on the condition being treated and the patient’s response, under the strict supervision of a physician.

• Standard Adult Dosage: 150 mg or 250 mg taken orally once daily in the morning.
• For Narcolepsy or OSA: 150 mg or 250 mg taken as a single dose in the morning.
• For Shift Work Sleep Disorder: 150 mg taken approximately 1 hour before the start of the work shift.
• Administration: Tablets should be swallowed whole with a glass of water. It can be taken with or without food; however, a high-fat meal may delay the onset of action.
• Dosage in Special Populations: Dosage adjustment is recommended in patients with severe hepatic impairment, with or without cirrhosis. A lower initial dose should be considered. Not recommended for patients with severe renal impairment.

It is crucial to follow the prescribing physician’s instructions exactly and not to adjust the dose without consultation.

Precautions

Before initiating treatment with Artvigil, several precautions must be considered:

• Cardiovascular Health: Exercise caution in patients with a history of left ventricular hypertrophy, mitral valve prolapse, myocardial ischemia, or other significant cardiovascular problems. Increases in blood pressure and heart rate have been observed.
• Psychiatric History: Use with caution in patients with a history of psychosis, depression, mania, or anxiety. Artvigil may increase the risk of such symptoms.
• Multidisciplinary Approach for OSA: Artvigil does not treat the airway obstruction in OSA. Patients must continue their primary treatment (e.g., CPAP) as prescribed.
• Pregnancy and Lactation: Artvigil is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether armodafinil is excreted in human milk; a decision should be made to discontinue nursing or discontinue the drug.
• Driving and Operating Machinery: Patients should be cautioned about operating automobiles or other hazardous machinery until they are reasonably certain that Artvigil does not adversely affect their performance.

Contraindications

Artvigil is contraindicated in patients with:

• Known hypersensitivity to armodafinil, modafinil, or any of the inactive ingredients in the formulation.
• A history of serious skin reactions, such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), in association with modafinil or armodafinil use.

Possible side effect

As with all medications, Artvigil can cause side effects, although not everybody gets them. The most common are generally mild to moderate.

• Very Common (>10%): Headache, nausea.
• Common (1-10%): Dizziness, insomnia, anxiety, dry mouth, diarrhea, nervousness, palpitations.
• Uncommon (0.1-1%): Depression, agitation, confusion, blurred vision, hypertension, tachycardia, dyspepsia.
• Rare but Serious: Serious skin rashes (including SJS, TEN, DRESS), angioedema, hypersensitivity reactions, psychiatric symptoms (e.g., psychosis, mania, hallucinations), suicidal ideation, chest pain, arrhythmias.

Patients should be instructed to discontinue therapy and contact their physician immediately at the first sign of a rash or other allergic reaction.

Drug interaction

Artvigil can interact with numerous medications by inducing certain cytochrome P450 enzymes (e.g., CYP3A4/5) or inhibiting others (e.g., CYP2C19). Key interactions include:

• Hormonal Contraceptives: Artvigil may reduce the effectiveness of cyclosporine, ethinyl estradiol, and other drugs metabolized by CYP3A4. Women using hormonal birth control should use an alternative or additional method of contraception during and for one month after stopping Artvigil.
• Anticoagulants (e.g., Warfarin): Dose monitoring and adjustment may be required due to potential changes in anticoagulant levels.
• Cyclosporine: Blood levels of cyclosporine may be reduced; monitoring is recommended.
• CYP2C19 Substrates (e.g., Omeprazole, Diazepam, Phenytoin): Artvigil may increase the plasma concentrations of these drugs.
• Monoamine Oxidase Inhibitors (MAOIs): Caution is advised when co-administering with MAOIs.

A comprehensive review of all concomitant medications with a physician is essential before starting treatment.

Missed dose

If a dose of Artvigil is missed, it should be taken as soon as possible on the same day. However, if it is late in the day, the missed dose should be skipped to avoid potential insomnia that night. Do not double the next dose to make up for a missed one. Patients should maintain their regular dosing schedule.

Overdose

In cases of suspected overdose, symptoms may include:

• Insomnia
• Central nervous system excitation (e.g., restlessness, agitation, confusion)
• Tachycardia (elevated heart rate)
• Hypertension (elevated blood pressure)
• Anxiety
• Diarrhea

There is no specific antidote for armodafinil overdose. Management involves symptomatic and supportive care, which may include cardiovascular monitoring and ensuring a calm environment. In cases of recent ingestion, gastric lavage may be considered. Hospitalization may be required for severe cases.

Storage

• Store Artvigil tablets at room temperature, between 20°C to 25°C (68°F to 77°F).
• Keep the medication in its original blister pack or container to protect it from light and moisture.
• Always keep all medicines out of the reach of children and pets.
• Do not use beyond the expiration date printed on the packaging.
• Properly dispose of any unused or expired medication as directed by a pharmacist or via a medicine take-back program.

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 medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects.

Reviews

• John D., diagnosed with Narcolepsy: “After years of struggling with sudden sleep attacks at work, Artvigil has been transformative. I take one tablet in the morning and can maintain focus and alertness throughout my entire workday. The difference in my productivity and overall quality of life is night and day. I experienced a mild headache for the first few days, but it subsided completely.”
• Maria L., Night Shift Nurse with SWSD: “Adapting to night shifts was destroying my life. I was exhausted at work and couldn’t sleep during the day. My doctor prescribed Artvigil to take before my shift. It doesn’t make me feel ‘wired’ like coffee did—just awake, alert, and competent. It’s been a crucial tool for me to perform my job safely and effectively.”
• David K., OSA patient on CPAP: “Even with perfect CPAP compliance, I still had a heavy cloud of sleepiness over me. Adding Artvigil was the missing piece. It cleared the fog and gave me the energy to be present for my family after work. It’s important to remember it’s an addition to CPAP, not a replacement.”