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Armodafinil (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.





Related medications:

Amfetamine (Amphetamine)

Atomoxetine (Strattera)

Dexamfetamine (Dexamphetamine)

Dexmethylphenidate (Focalin)

Eszopiclone (Lunesta)

Fencamfamin (Fencamfamine)

Fenetylline (Fenethylline)

Fenozolone (Ordinator)

Lisdexamfetamine (Vyvanse)

Metamfetamine (Metamphetamine)

Methylphenidate (Concerta, Ritalin)

Modafinil (Modalert, Provigil)

Nitrazepam (Mogadon)

Pemoline (Cylert)

Zolpidem (Ambien)

Zopiclone (Imovane)


Pharmacological and medical categories:

Alpha-sympathomimetic agents

Antidepressants

Central stimulants

Cognitive enhancers

Eugeroic drugs

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

Sympathomimetic agents

Wakefulness-promoting medicines


ATC codes:

N - Nervous system

N06 - Psychoanaleptics

N06B - Psychostimulants, agents used for adhd and nootropics

N06BA - Centrally acting sympathomimetics

N06BA13 - Armodafinil


ICD-10 codes:

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, 250 mg tablets.

Waklert (Armodafinil) 50 mg, 150 mg tablets.

Artvigil (Armodafinil) 150 mg tablets.


Overdosage:

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 Nuvigil, Waklert (Armodafinil) tablets overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.


Contraindications:

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.


Drug interactions:

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.


Pregnancy categories:

B3 - Australia

C - United States (Risk cannot be ruled out)


Salts and other forms:

Armodafinil Base


Synonyms, international and chemical names:

(-)-2-[(R)-(Diphenylmetyl)sulfinyl]acetamide

2-[(R)-(Diphenylmetyl)sulfinyl])acetamide

Acetamide, 2-[(diphenylmetyl)sulfinyl]-, (-)-

Armodafinilo

Armodafinilum

(R)-(-)Modafinil

Modafinil enantiopure compound

R-Modafinil


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


References:

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 10/15/2023): https://medlineplus.gov/druginfo/meds/a607067.html

Nuvigil (Armodafinil) tablets drug label on DailyMed (revised December 31, 2022): https://dailymed.nlm.nih.gov/dailymed/drugInfo...

Teva Armodafinil tablets drug label on DailyMed (revised January 31, 2023): https://dailymed.nlm.nih.gov/dailymed/drugInfo...

Sandoz Armodafinil tablets drug label on DailyMed (revised January 18, 2023): 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 12/2023): 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 February 2024): 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 official website powered by Cephalon, Inc. and Teva Pharmaceuticals: https://www.nuvigil.com/

Nuvigil (Armodafinil) tablets for oral use prescribing information and medication guide from its official website (revised 12/2022): https://www.nuvigil.com/globalassets/nuvigil-consumer/prescribinginformation.pdf

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: February 2024