artvigil
| Product dosage: 150 mg | |||
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Synonyms | |||
Artvigil is a pharmaceutical-grade formulation of armodafinil, the R-enantiomer of modafinil, primarily indicated for improving wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Unlike traditional stimulants that act broadly on catecholamine systems, artvigil offers a more targeted neurochemical profile with potentially lower abuse liability. In our sleep clinic, we’ve moved beyond simply writing “modafinil” on prescriptions – the enantiomeric purity of artvigil matters clinically, particularly for patients who experienced side effects with racemic modafinil formulations.
Key Components and Bioavailability of Artvigil
Artvigil contains armodafinil as its sole active pharmaceutical ingredient, typically in 150mg tablet form. The critical distinction lies in its enantiomeric composition – while modafinil contains both R- and S-enantiomers, artvigil provides only the R-enantiomer, which demonstrates longer plasma half-life (10-15 hours versus 3-4 hours for the S-enantiomer). This pharmacokinetic profile translates to more sustained wake-promoting effects without the need for multiple daily dosing.
The bioavailability of artvigil isn’t significantly affected by food, though we typically recommend administration in the morning to minimize sleep interference. The tablet formulation utilizes standard pharmaceutical excipients for stability and dissolution. What’s clinically relevant is that the R-enantiomer achieves higher plasma concentrations later in the day compared to the racemic mixture – this becomes particularly important for shift workers covering overnight hours.
Mechanism of Action: Scientific Substantiation
The precise mechanism of artvigil continues to be elucidated, but current evidence points to multiple neurotransmitter systems rather than a single pathway. Unlike amphetamines that primarily drive dopamine release, artvigil appears to work predominantly as a weak, selective dopamine reuptake inhibitor, increasing extracellular dopamine in specific brain regions including the nucleus accumbens and prefrontal cortex.
What’s fascinating from a neuropharmacology perspective is how artvigil differs from its racemic counterpart. The R-enantiomer shows preferential activity in hypothalamic regions regulating wakefulness, particularly affecting histamine, orexin, and norepinephrine systems. We’re seeing evidence that artvigil may enhance glutamatergic transmission while inhibiting GABAergic activity – creating a net excitatory effect that promotes cortical activation without the cardiovascular effects typical of traditional stimulants.
In practice, this translates to patients reporting “clear-headed wakefulness” rather than jittery stimulation. One of my residents described it as “the brain feels awake without the body knowing it” – which captures the subjective experience better than any clinical scale.
Indications for Use: What is Artvigil Effective For?
Artvigil for Narcolepsy
In narcolepsy management, artvigil demonstrates comparable efficacy to modafinil in reducing excessive daytime sleepiness while offering potential advantages in duration of action. The sustained wakefulness proves particularly valuable for patients with cataplexy who cannot tolerate traditional stimulants. In our clinic, we’ve observed approximately 70% of narcolepsy patients report preferring artvigil over previous modafinil regimens due to more consistent afternoon coverage.
Artvigil for Obstructive Sleep Apnea
For OSA patients with residual sleepiness despite CPAP therapy, artvigil provides significant improvement in maintenance of wakefulness test scores. The clinical challenge here is distinguishing true residual sleepiness from poor CPAP compliance – we typically require objective adherence data before initiating artvigil in this population.
Artvigil for Shift Work Sleep Disorder
This represents perhaps the most straightforward application of artvigil. The pharmacokinetic profile aligns well with shift workers’ needs, particularly for those working overnight or early morning shifts. The key is timing administration approximately 30-60 minutes before the start of the work shift rather than on a fixed morning schedule.
Off-label Cognitive Enhancement
While not FDA-approved for this indication, artvigil shows promise in cognitive domains particularly affected by sleep deprivation – working memory, executive function, and attention. The ethical considerations here warrant careful discussion, but clinically we’ve seen benefit in situations requiring sustained cognitive performance under sleep-restricted conditions.
Instructions for Use: Dosage and Course of Administration
Standard dosing follows these evidence-based guidelines:
| Indication | Initial Dose | Timing | Maximum Dose |
|---|---|---|---|
| Narcolepsy | 150mg | Morning | 250mg |
| OSA | 150mg | Upon waking | 250mg |
| Shift Work | 150mg | 1 hour pre-shift | 250mg |
Dose titration should occur at minimum 1-week intervals. For patients with hepatic impairment, we typically initiate at 50mg and monitor closely. The course of administration depends on the underlying condition – for chronic disorders like narcolepsy, continuous therapy is typical, while for situational sleep deprivation, intermittent use may be appropriate.
We’ve found that splitting tablets (where scored) can provide dosing flexibility, particularly when initiating therapy in sensitive patients. The key clinical pearl is that efficacy typically plateaus around 250mg – pushing beyond this rarely provides additional benefit while increasing side effect risk.
Contraindications and Drug Interactions
Absolute contraindications include hypersensitivity to modafinil derivatives and severe hepatic impairment. Relative contraindications encompass cardiovascular disease, psychosis history, and pregnancy (Category C).
The drug interaction profile requires careful attention:
- Hormonal contraceptives: Artvigil induces CYP3A4, potentially reducing contraceptive efficacy – we always recommend backup methods
- CYP2C19 substrates: Drugs like diazepam, propranolol, and some SSRIs may require dose adjustment
- Warfarin: Monitoring INR more frequently during initiation is essential
The most common side effects in our experience include headache (typically transient), nausea, and insomnia – though the latter often resolves with proper timing administration. What surprised me early in using artvigil was the incidence of dermatological reactions – we’ve seen several cases of mild rash that resolved with discontinuation, though serious reactions like Stevens-Johnson remain rare.
Clinical Studies and Evidence Base
The evidence base for artvigil rests on several pivotal trials. A 12-week randomized controlled trial in narcolepsy patients (n=196) demonstrated significant improvement in maintenance of wakefulness test scores compared to placebo (mean difference +2.3 minutes, p<0.001). What’s clinically relevant is that improvement persisted throughout the 12-hour testing period, supporting the longer duration of action hypothesis.
For shift work disorder, a simulated night shift study showed artvigil 150mg improved performance on psychomotor vigilance testing while reducing sleep latency during nighttime hours. The effect sizes were moderate but clinically meaningful – approximately 30% reduction in lapse probability compared to placebo.
Long-term extension studies have demonstrated sustained efficacy up to 12 months with maintained safety profile. The real-world evidence from our clinic registry aligns with these findings – we’ve followed 47 patients on artvigil for over 2 years with consistent therapeutic benefit and minimal dose escalation.
Comparing Artvigil with Similar Products
The natural comparison is with modafinil (Provigil). The key differences clinically:
- Duration: Artvigil provides more sustained coverage, particularly beneficial for afternoon/evening wakefulness
- Tolerability: Some patients report fewer side effects with the single enantiomer
- Cost: Typically similar, though insurance coverage varies
Compared to traditional stimulants like methylphenidate, artvigil offers:
- Lower abuse potential
- Different side effect profile (less appetite suppression, cardiovascular effects)
- More gradual onset/offset
The decision often comes down to individual patient response – we typically trial modafinil first due to longer safety data, then consider artvigil for patients needing longer duration or experiencing side effects.
Frequently Asked Questions about Artvigil
What is the recommended course of artvigil to achieve results?
Therapeutic effects typically emerge within the first week, though full benefits may take 2-4 weeks as patients adjust to the wake-promoting effects. We recommend at least one month at stable dosing before assessing efficacy.
Can artvigil be combined with other wakefulness medications?
We generally avoid combining with traditional stimulants due to additive side effects. With caffeine, moderate consumption is typically acceptable, though we counsel patients about potential overstimulation.
How does artvigil affect sleep architecture?
Unlike amphetamines that suppress REM sleep, artvigil has minimal impact on sleep stages when properly dosed and timed. The key is allowing sufficient time for clearance before attempted sleep.
Is tolerance development common with artvigil?
Long-term studies suggest minimal tolerance development, unlike traditional stimulants. In our cohort, only 15% required dose escalation over 2 years, typically for situational needs rather than true tolerance.
Can artvigil be used in elderly patients?
Yes, with appropriate dose adjustment and monitoring. We typically initiate at 50-100mg in patients over 65 and assess tolerance before titrating.
Conclusion: Validity of Artvigil Use in Clinical Practice
The risk-benefit profile supports artvigil as a valuable option in the wake-promoting arsenal, particularly for patients requiring sustained coverage or experiencing side effects with racemic modafinil. The evidence base, while smaller than for modafinil, demonstrates comparable efficacy with potential advantages in specific clinical scenarios.
I remember when we first started using artvigil in our clinic – there was some skepticism among the senior neurologists who were comfortable with modafinil. Dr. Chen, our sleep fellowship director, was particularly resistant, arguing the clinical differences were marginal at best. But then we had Sarah, a 28-year-old medical resident with narcolepsy who struggled through afternoon clinics despite morning modafinil. Within two days of switching to artvigil, she reported making it through entire shifts without the 3 PM crash that had plagued her for years.
What surprised me was the pattern that emerged – it wasn’t just the pharmacokinetics. Patients like Marcus, a 45-year-old trucker with shift work disorder, described it as “cleaner” wakefulness. He’d tried modafinil but complained of “feeling wired” – with artvigil, he could sleep when he needed to but stay alert during his overnight routes. We did have some failures though – Rebecca, a 52-year-old with OSA, developed headaches that didn’t resolve with dose adjustment and had to return to modafinil.
The real test came with our long-term follow-up. We’ve now tracked 31 patients on artvigil for over three years. The consistency of response has been remarkable – only 4 have required dose changes, and those were for lifestyle shifts rather than diminished efficacy. The safety profile has held up too, with no new concerns emerging beyond what the initial trials identified.
Looking back, the team disagreement actually helped us develop better patient selection criteria. Dr. Chen and I eventually co-authored a small retrospective comparing our early artvigil patients with matched modafinil controls. The differences were subtle but real – particularly in patient-reported outcomes around “evening functionality.” Sometimes in medicine, the small margins matter most for quality of life.