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Nuvigil (ARMODAFINIL)
Nuvigil works by selectively targeting the D(2) dopamine receptor to increase wakefulness and alertness.
Nuvigil (Armodafinil) is a small molecule drug class armodafinil, originally developed by CEPHALON and currently owned by Nuvo Pharms. It targets the D(2) dopamine receptor and is FDA approved for treating narcolepsy, sleepiness due to obstructive sleep apnea, and sleepiness due to shift work sleep disorder. Nuvigil is off-patent, with six generic manufacturers available. Key safety considerations include potential interactions with other medications and increased risk of psychiatric symptoms. As an off-patent medication, its commercial status is largely driven by generic competition.
At a glance
| Generic name | ARMODAFINIL |
|---|---|
| Sponsor | Nuvo Pharms |
| Drug class | armodafinil |
| Target | D(2) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2007 |
Mechanism of action
The mechanism(s) through which armodafinil promotes wakefulness is unknown. Armodafinil (R-modafinil) has pharmacological properties similar to those of modafinil (a mixture of R- and S-modafinil), to the extent tested in animal and in vitro studies. The and S-enantiomers have similar pharmacological actions in animals.Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines.Modafinil-induced wakefulness can be attenuated by the 1-adrenergic receptor antagonist, prazosin; however, modafinil is inactive in other in vitro assay systems known to be responsive to -adrenergic agonists such as the rat vas deferens preparation.Armodafinil is an indirect dopamine receptor agonist; both armodafinil and modafinil bind in vitro to the dopamine transporter and inhibit dopamine reuptake. For modafinil, this ac
Approved indications
- Narcolepsy
- Sleepiness Due To Obstructive Sleep Apnea
- Sleepiness Due To Shift Work Sleep Disorder
Common side effects
- Headache
- Nausea
- Dizziness
- Insomnia
- Palpitations
- Diarrhea
- Dry Mouth
- Abdominal Pain Upper
- Constipation
- Vomiting
- Loose Stools
- Fatigue
Key clinical trials
- Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder (PHASE4)
- WAKIX® (Pitolisant) Pregnancy Registry
- Sleep/Wake State Assessment with Non-invasive Earbuds (NA)
- Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma (PHASE3)
- Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer (PHASE1,PHASE2)
- The Nuvigil and Provigil Pregnancy Registry
- Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury (PHASE3)
- Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nuvigil CI brief — competitive landscape report
- Nuvigil updates RSS · CI watch RSS
- Nuvo Pharms portfolio CI