pharmacopeia
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/api/v1/drug/armodafinil

Mechanism of action

Sourced from openFDA

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.

Dopamine

Indications

Sourced from openFDA
  • Armodafinil tablets are 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 tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.ICD-10: G47.419

Contraindications

Sourced from openFDA
  • Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil.contraindicated

Dosage & administration

Sourced from openFDA

The recommended dosage of armodafinil tablets for each indication is as follows: OSA or Narcolepsy: 150 mg to 250 mg once a day in the morning. (2.1) SWD: 150 mg once a day, taken approximately one hour prior to start of the work shift. (2.2) Hepatic Impairment: reduced dose in patients with severe hepatic impairment. (2.3 , 12.3) Geriatric Patients: consider lower dose. (2.4 , 12.3) 2.1 Dosage in Obstructive Sleep Apnea (OSA) and Narcolepsy The recommended dosage of armodafinil tablets for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning. In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1 , 14.2) ] . 2.2 Dosage in Shift Work Disorder (SWD) The recommended dosage of armodafinil tablets for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift. 2.3 Dosage Modification in Patients with Severe Hepatic Impairment In patients with severe hepatic impairment, the dosage of armodafinil tablets should be reduced [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. 2.4 Use in Geriatric Patients Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5) ].

Warnings & precautions

Sourced from openFDA

Serious Rash, including Stevens-Johnson Syndrome: discontinue armodafinil at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) DRESS/Multi-organ Hypersensitivity Reactions: if suspected, discontinue armodafinil. ( 5.2 ) Angioedema and Anaphylaxis Reactions: if suspected, discontinue armodafinil. ( 5.3 ) 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. ( 5.4 ) Psychiatric Symptoms: use particular caution in treating patients with a history of psychosis, depression, or mania. Consider discontinuing armodafinil if psychiatric symptoms develop. ( 5.5 ) Known Cardiovascular Disease: consider increased monitoring. ( 5.7 ) 5.1 Serious Dermatologic Reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrosis Serious rash requiring hospitalization and discontinuation of treatment has been reported in association with the use of armodafinil or modafinil (the racemic mixture of S- and R-enantiomers). Armodafinil has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described below and elsewhere in the labeling: Serious Dermatologic Reactions [see Warnings and Precautions (5.1) ] Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.2) ] Angioedema and Anaphylaxis Reactions [see Warnings and Precautions (5.3) ] Persistent Sleepiness [see Warnings and Precautions (5.4) ] Psychiatric Symptoms [see Warnings and Precautions (5.5) ] Effects on Ability to Drive and Use Machinery [see Warnings and Precautions (5.6) ] Cardiovascular Events [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥5%): headache, nausea, dizziness, and insomnia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Armodafinil has been evaluated for safety in over 1,100 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy. Most Common Adverse Reactions In the placebo-controlled clinical trials, the most common adverse reactions (≥ 5%) associated with the use of armodafinil more frequently than in placebo-treated patients were headache, nausea, dizziness, and insomnia. The adverse reaction profile was similar across the studies.

Use in specific populations

Sourced from openFDA

Pregnancy: based on animal data, may cause fetal harm. (8.1) 8.1 Pregnancy Risk Summary Limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes. Intrauterine growth restriction and spontaneous abortion have been reported in association with armodafinil and modafinil. Although the pharmacology of armodafinil is not identical to that of the sympathomimetic amines, armodafinil shares some pharmacologic properties with this class [see Clinical Pharmacology (12.1) ] . Some sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions. In animal reproduction studies of armodafinil (R-modafinil) and modafinil (a mixture of R-and S-modafinil) conducted in pregnant rats (armodafinil, modafinil) and rabbits (modafinil) during organogenesis, evidence of developmental toxicity (increased embryofetal and offspring mortality, decreased fetal growth) was observed at clinically relevant plasma exposures. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S.

Pharmacokinetics

Sourced from openFDA
Metabolism
Armodafinil exhibits linear time-independent kinetics following single and multiple oral dose administration. Increase in systemic exposure is proportional over the dose range of 50 to 400 mg.

Overdosage

Sourced from openFDA

Fatal overdoses involving modafinil alone or involving armodafinil 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 armodafinil overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.

Approval history

Sourced from openFDA
  • Jun 15, 2007NDANDA021875Nuvo Pharms
  • Jun 1, 2012ANDAANDA200043Mylan Pharms Inc
  • Nov 28, 2016ANDAANDA202768Natco Pharma Ltd
  • Mar 6, 2018ANDAANDA206069Aurobindo Pharma Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
20,859 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective1,5627.5%
  2. 2Fatigue1,4967.2%
  3. 3Nausea1,4657.0%
  4. 4Headache1,3966.7%
  5. 5Anxiety1,1745.6%
  6. 6Somnolence1,0965.3%
  7. 7Depression1,0114.8%
  8. 8Insomnia9674.6%
  9. 9Feeling Abnormal9544.6%
  10. 10Fall8904.3%
  11. 11Dizziness8704.2%
  12. 12Weight Decreased7433.6%
  13. 13Pain7063.4%
  14. 14Condition Aggravated6943.3%
  15. 15Sleep Apnoea Syndrome6253.0%

Literature

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Recent PubMed references pinned to Armodafinil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 62 ClinicalTrials.gov registrations naming Armodafinil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Armodafinil work?
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.
What is Armodafinil used for?
According to FDA labeling, Armodafinil carries indications including: Armodafinil tablets are 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 tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Armodafinil?
Armodafinil is classified as Centrally acting sympathomimetics, Dopamine Agonists, Increased Sympathetic Activity.
What are the brand names for Armodafinil?
Armodafinil is marketed under brand names including Nuvigil.
What are the contraindications for Armodafinil?
Armodafinil labeling lists contraindications including: Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil.. Always consult the full prescribing information and a clinician.
Note. Data for armodafinil is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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