Nuvigil (armodafinil) for narcolepsy
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What is Nuvigil for narcolepsy?
Nuvigil (armodafinil) is an oral medication that’s approved to improve wakefulness in adults with excessive sleepiness associated with narcolepsy.
In narcolepsy, the brain can’t properly regulate sleep-wake cycles, leading to excessive daytime sleepiness, or an overwhelming urge to sleep at any time of day.
The exact mechanisms by which Nuvigil promotes wakefulness are not known, but it is thought to work in part by increasing the levels of a signaling molecule called dopamine, which in turn boosts wake-promoting signals in the brain. Nuvigil works similarly to its predecessor, Provigil (modafinil), but is designed to last longer in the body and have more sustained effects.
Taken as oral tablets, Nuvigil is marketed in the U.S. by Apotex, but generic versions are also available. It is also approved for managing sleepiness in people with obstructive sleep apnea and shift work disorder.
Therapy snapshot
| Brand name | Nuvigil |
| Chemical name | Armodafinil |
| Usage | Used to improve wakefulness in adults with narcolepsy |
| Administration | Oral tablets |
Who with narcolepsy can take Nuvigil?
In the U.S., Nuvigil is approved to improve wakefulness in adults with excessive sleepiness associated with narcolepsy.
Nuvigil is contraindicated, or should not be used, by people with a history of immune reactions (hypersensitivity) to its active ingredient, any of its inactive ingredients, or the active ingredient in Provigil.
How is Nuvigil administered in narcolepsy?
Nuvigil comes as oral tablets, taken once a day in the morning at a recommended dose of 150 to 250 mg. The dose may be reduced in older patients or people with severe liver impairment.
Nuvigil in narcolepsy clinical trials
Nuvigil’s U.S. approval was supported by data from a Phase 3 clinical trial (NCT00078377) involving 196 adults with narcolepsy. Participants were randomly assigned to receive once-daily Nuvigil (150 or 250 mg) or a placebo for three months. The data showed that compared with the placebo, Nuvigil:
- significantly improved measures of wakefulness
- was associated with higher rates of clinician-rated improvements in overall clinical status
- led to improvements in memory, attention, and fatigue
Although both tested Nuvigil doses were effective, the higher dose led to greater improvements in some measures of wakefulness. Nighttime sleep was not affected by the use of Nuvigil.
Nuvigil side effects
The most common side effects of Nuvigil include:
- headache
- nausea
- dizziness
- insomnia
Nuvigil also comes with warnings for less common, but potentially serious side effects:
- serious rashes, including Stevens-Johnson syndrome, a rare and life-threatening reaction
- multiorgan hypersensitivity reactions, which may be life-threatening
- swelling under the skin (angioedema) or anaphylaxis, a life-threatening systemic immune reaction
- psychiatric problems, especially in people with a history of these issues
- cardiovascular problems in people with existing heart issues
Patients taking Nuvigil will be monitored for these complications. Should they occur, Nuvigil may need to be discontinued.
Nuvigil may interact with other medications, including hormonal contraceptives (i.e., birth control pills). Alternative or additional methods of contraception should be used while taking Nuvigil and for one month afterward.
Some people taking Nuvigil may continue to experience excessive sleepiness that makes activities like driving unsafe. Patients should work with their doctors to determine when it is safe to resume these activities.
Nuvigil may produce positive mood-altering effects. There have been reports of Nuvigil abuse, which poses a risk of physical dependence and overdose. Patients using the medication will be monitored for signs of abuse or misuse.
Narcolepsy News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be 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. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
