- Armodafinil
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Armodafinil 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 SMILES eMolecules & PubChem (what is this?) (verify) 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] Armodafinil is an enantiopure drug consisting of just the active (−)-(R)-enantiomer of the racemic drug modafinil (Provigil).
Contents
Indications
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.[2]
Cephalon plans to conduct clinical trials evaluating the use of Nuvigil as a treatment for serious medical conditions such as bipolar depression and fatigue in conditions such as Parkinson's disease and cancer.[3] In June, 2010, it was revealed that a phase II study of Nuvigil as an adjunctive therapy in adults with schizophrenia had failed to meet the primary endpoints, and the clinical program was subsequently ceased.[4]
The drug was being considered for the first FDA-approved medicinally-specific drug for combating jet-lag.[5] but on March 30, 2010, the FDA declined to approve use of Nuvigil to treat jet lag.[6]
Dosage
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.[2]
Side effects
Armodafinil's common side effects include headache, nausea, insomnia, lack of appetite, dizziness, agitation, anxiety and high blood pressure.[2]
See also
References
- ^ "CDER Drug and Biologic Approvals for Calendar Year 2007". http://www.fda.gov/cder/rdmt/InternetNDA07.htm. Retrieved 2008-01-21.
- ^ a b c "Nuvigil (Armodafinil) Drug Information: Uses, Side Effects, Drug Interactions and Warnings at RxList". http://www.rxlist.com/nuvigil-drug.htm.
- ^ "Cephalon - Pipeline,". http://www.cephalon.com/our-science/pipeline/. Retrieved 2008-01-21.
- ^ "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.
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