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Armodafinil (Nuvigil, Waklert) 150 mg tablets
Armodafinil brand, Waklert brand, Nuvigil generic
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(trade names include Nuvigil, Artvigil, Waklert, Armod, Neoresotyl
) is a wakefulness-promoting agent from centrally acting sympathomimetics pharmacological group. This medication is used as eugeroic to treat excessive daytime sleepiness and hypersomnia caused by obstructive sleep apnea, hypopnea syndrome, shift work sleep disorder, narcolepsy, jet lag, other sleep related problems. It is also commonly used off-label for the treatment of attention deficit hyperactivity disorder (ADHD), bipolar disorder, schizophrenia, chronic fatigue syndrome, major depressive disorder, fibromyalgia; to improve vigilance, cognition and concentration. Armodafinil works as CNS stimulant and it has pharmacological properties related to those of modafinil.
Methylphenidate (Concerta, Ritalin)
Modafinil (Modalert, Provigil)
Pharmacological and medical categories:
Medications acting on the central nervous system (CNS)
Modafinil enantiopure compounds
Pain relief drugs
Pharmaceutical products for ADHD
Preparations for the treatment of excessive sleepiness
Sleep aid pills
N - Nervous system
N06 - Psychoanaleptics
N06B - Psychostimulants, agents used for adhd and nootropics
N06BA - Centrally acting sympathomimetics
N06BA13 - Armodafinil
Schizophrenia - F20
Bipolar disorder - F31
Major depressive disorder, single episode - F32
Major depressive disorder, recurrent - F33
Nonorganic sleep disorders - F51
Attention-deficit hyperactivity disorders - F90
Other degenerative diseases of nervous system, not elsewhere classified - G31
Mild cognitive impairment, so stated - G31.84
Sleep disorders - G47
Hypersomnia - G47.1
Circadian rhythm sleep disorders - G47.2
Circadian rhythm sleep disorder, jet lag type - G47.25
Circadian rhythm sleep disorder, shift work type - G47.26
Sleep apnea - G47.3
Narcolepsy - G47.41
Other sleep disorders - G47.8
Other and unspecified soft tissue disorders, not elsewhere classified - M79
Fibromyalgia - M79.7
Malaise and fatigue - R53
Chronic fatigue, unspecified - R53.82
Indications and usage:
Armodafinil (Nuvigil, Artvigil, Waklert) is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
Limitations of Use
In OSA, armodafinil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
Dosage and administration:
The recommended dosage of Nuvigil or Waklert for each indication is as follows:
OSA or Narcolepsy: 150 mg to 250 mg once a day in the morning.
SWD: 150 mg once a day, taken approximately one hour prior to start of the work shift.
Hepatic Impairment: reduced dose in patients with severe hepatic impairment.
Geriatric Patients: consider lower dose.
Dosage forms and strengths:
Nuvigil (Armodafinil) 50 mg, 150 mg, 200 mg, and 250 mg tablets.
Waklert (Armodafinil) 50 mg, 150 mg tablets.
Artvigil (Armodafinil) 150 mg tablets.
Fatal overdoses involving modafinil alone or involving Waklert, Nuvigil or modafinil in combination with other drugs have been reported in the postmarketing setting. Symptoms most often accompanying armodafinil or modafinil overdose, alone or in combination with other drugs, have included anxiety, dyspnea, insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.
No specific antidote exists for the toxic effects of a Nuvigil, Waklert (Armodafinil) tablets overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.
Armodafinil (Waklert, Nuvigil) is contraindicated in patients with known hypersensitivity to modafinil or armodafinil.
Warnings and precautions:
Serious rash, including Stevens-Johnson Syndrome: discontinue Nuvigil and Waklert at the first sign of rash, unless the rash is clearly not drug-related.
DRESS/Multi-organ hypersensitivity reactions: if suspected, discontinue armodafinil.
Angioedema and anaphylaxis reactions: if suspected, discontinue this drug.
Persistent sleepiness: assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity.
Psychiatric symptoms: use particular caution in treating patients with a history of psychosis, depression, or mania. Consider discontinuing Waklert or Nuvigil (Armodafinil) if psychiatric symptoms develop.
Known cardiovascular disease: consider increased monitoring.
Adverse reactions, side effects:
Most common adverse reactions of armodafinil (>=5%): headache, nausea, dizziness, and insomnia.
To report suspected adverse reactions, contact Cephalon, Inc., Teva Pharmaceuticals or your local FDA.
Steroidal contraceptives (e.g., ethinyl estradiol): use alternative or concomitant methods of contraception while taking armodafinil pills and for one month after discon-tinuation of Nuvigil or Waklert treatment.
Cyclosporine: blood concentrations of cyclosporine may be reduced.
CYP2C19 substrates, such as omeprazole, phenytoin, and diazepam: exposure of these medications may be increased.
Use in specific populations:
Pregnancy: based on animal data, may cause fetal harm.
Drug abuse and dependence:
Controlled substance: Waklert and Nuvigil tablets contains armodafinil, a Schedule IV controlled substance in some countries, for example, in the USA and Canada.
B3 - Australia
C - United States (Risk cannot be ruled out)
Salts and other forms:
Synonyms, international and chemical names:
Acetamide, 2-[(diphenylmetyl)sulfinyl]-, (-)-
Modafinil enantiopure compound
Brands, generics, trade names:
Armod - Emcure Pharmaceuticals
Armodafinil - Apotex, Mylan, Teva, Watson Pharmaceuticals
Artvigil - HAB Pharmaceuticals & Research
Arvigil - Andromaco Laboratorios
Neoresotyl - Abbott, Drugtech Laboratorio, Recalcine Laboratorios
Nuvigil - Cephalon, A-S Medication Solutions, Kaiser Foundation Hospitals, Stat Rx USA, Teva
Waklert - Sun Pharmaceutical Industries
Armodafinil main article on Wikipedia: https://en.wikipedia.org/wiki/Armodafinil
Armodafinil compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Armodafinil
Armodafinil abstract on PubMed: https://pubmed.ncbi.nlm.nih.gov/19689169/
Armodafinil medicine on DrugBank: https://go.drugbank.com/drugs/DB06413
Armodafinil FAQ on MedlinePlus (revised 09/15/2016): https://medlineplus.gov/druginfo/meds/a607067.html
Nuvigil (Armodafinil) tablets drug label on DailyMed (revised November 30, 2018): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Teva Armodafinil tablets drug label on DailyMed (revised December 31, 2018): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Sandoz Armodafinil tablets drug label on DailyMed (revised December 31, 2018): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Mylan Armodafinil tablets drug label on DailyMed (revised September 17, 2018): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Lupin Armodafinil tablets drug label on DailyMed (revised May 1, 2020): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Armodafinil containing drugs on Drugs-About.com: https://drugs-about.com/ing/armodafinil.html
Armodafinil for sale on Pharma Doctor (revised May 2022): https://pharma-doctor.com/armodafinil.html
Nuvigil (Armodafinil) 50 mg, 150 mg, 200 mg, 250 mg tablets for oral use official prescribing information and medication guide from the U.S. FDA (revised 02/2017): https://www.accessdata.fda.gov/drugsatfda_docs/label...
Nuvigil (Armodafinil) tablets for oral use official prescribing information and medication guide from Cephalon and Teva pharmaceutical companies (revised 11/2018): https://www.nuvigil.com/globalassets/nuvigil-consumer/prescribinginformation.pdf
Nuvigil (Armodafinil) tablets official website powered by Cephalon, Inc. and Teva Pharmaceuticals: https://www.nuvigil.com/
Nuvigil (Armodafinil) 50 mg, 150 mg, 250 mg tablets patient information leaflet on NPS MedicineWise (revised February 2020): https://www.nps.org.au/assets/medicines/...
Revised: August 2022
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