Armodafinil
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| Systematic (IUPAC) name | |
| (–)-2-[(R)-(diphenylmethyl)sulfinyl]acetamide | |
| Clinical data | |
| AHFS/Drugs.com | monograph |
| MedlinePlus | a602016 |
| Pregnancy cat. | C |
| Legal status | Schedule IV (US) ℞ Prescription only |
| Routes | Oral |
| Pharmacokinetic data | |
| Metabolism | Hepatic, including CYP3A4 and other pathways |
| Half-life | 12-15 hrs |
| Excretion | Urine (as metabolites) |
| Identifiers | |
| CAS number | 112111-43-0  |
| ATC code | N06BA07 |
| PubChem | CID 9690109 |
| ChemSpider | 7962943  |
| UNII | V63XWA605I |
| KEGG | D03215 |
| ChEMBL | CHEMBL1201192 |
| Chemical data | |
| Formula | C15H15NO2S |
| Mol. mass | 273.351 |
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Armodafinil (Nuvigil) is a stimulant-like drug produced by the pharmaceutical company Cephalon Inc., which was approved by the FDA on June 15, 2007.[1][2] Armodafinil is an enantiopure drug consisting of just the active (−)-(R)-enantiomer of the racemic drug modafinil (Provigil).
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[edit] Medical uses
[edit] Sleep disorders
Armodafinil is approved by the FDA for the treatment of narcolepsy and shift work sleep disorder, and as an adjunctive treatment for obstructive sleep apnea.[3] For narcolepsy and obstructive sleep apnea, armodafinil is taken as a once daily 150 mg or 250 mg dose in the morning. For shift work sleep disorder, 150 mg of armodafinil are taken one hour prior to starting work. Slow dose titration is needed to mitigate some side effects.[3]
[edit] Depression and schizophrenia
Cephalon plans to conduct one or more Phase III clinical trials evaluating the use of Nuvigil as a adjunctive treatment for bipolar depression.[4] In June, 2010, it was revealed that a phase II study of armodafinil as an adjunctive therapy in adults with schizophrenia had failed to meet the primary endpoints, and the clinical program was subsequently ceased.[5]
[edit] Jet lag
The drug was being considered for the first FDA-approved medicinally-specific drug for combating jet-lag.[6] but on March 30, 2010, the FDA declined to approve use of Nuvigil to treat jet lag.[7]
[edit] Adverse effects
Armodafinil's common side effects include headache, nausea, insomnia, lack of appetite, dizziness, agitation, anxiety and high blood pressure.[3]
[edit] See also
[edit] References
- ^ "CDER Drug and Biologic Approvals for Calendar Year 2007". Archived from the original on 23 February 2008. http://www.fda.gov/cder/rdmt/InternetNDA07.htm. Retrieved 2008-01-21.[dead link]
- ^ "Search results from the "OB_Rx" table for query on "021875."", Orange Book (USFDA), March 2012, http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=021875&TABLE1=OB_Rx, retrieved April 30, 2012
- ^ a b c RXList-nuvigil
- ^ "Cephalon - Pipeline". http://www.cephalon.com/our-science/pipeline/. Retrieved April 30, 2012.
- ^ "Cephalon Provides Clinical Update on Phase II Study of NUVIGIL as an Adjunctive Therapy in Adults with Schizophrenia,". http://www.prnewswire.com/news-releases/cephalon-provides-clinical-update-on-phase-ii-study-of-nuvigil-as-an-adjunctive-therapy-in-adults-with-schizophrenia-95449199.html. Retrieved 2011-08-21.
- ^ A Drug’s Second Act: Battling Jet Lag Retrieved 2010-3-30,
- ^ Regulators Reject a Drug Maker’s Plan to Use Its Alertness Pill to Overcome Jet Lag Retrieved 2010-3-30.
[edit] External links
- NUVIGIL.com - official site
- "A single dose of armodafinil significantly promotes vigilance 11 hours post-dose"
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