pharmacopeia
GET
/api/v1/drug/modafinil
2D structure
2-benzhydrylsulfinylacetamide
SMILES C1=CC=C(C=C1)C(C2=CC=CC=C2)S(=O)CC(=O)N
InChIKey YFGHCGITMMYXAQ-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

The mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of the sympathomimetic amines.

Dopamine Uptake

Indications

Sourced from openFDA
  • Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.ICD-10: G47.419

Contraindications

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

Dosage & administration

Sourced from openFDA

The recommended dosage of modafinil tablets for each indication is as follows: • Narcolepsy or OSA: 200 mg once a day in the morning. ( 2.1 ) • SWD: 200 mg once a day, taken approximately one hour prior to start of the work shift. ( 2.2 ) • Severe Hepatic Impairment: reduce dose to half the recommended dose. ( 2.3 , 12.3 ) • Geriatric Patients: consider lower dose. ( 2.4 , 12.3 ) 2.1 Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA) The recommended dosage of modafinil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning. Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 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 modafinil tablets for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift . 2.3 Dosage Modifications in Patients with Severe Hepatic Impairment In patients with severe hepatic impairment, the dosage of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [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 modafinil at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) • Angioedema and Anaphylaxis Reactions: If suspected, discontinue modafinil. ( 5.2 ) • Multi-organ Hypersensitivity Reactions: If suspected, discontinue modafinil. ( 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 caution in patients with a history of psychosis, depression, or mania. Consider discontinuing modafinil if psychiatric symptoms develop. ( 5.5 ) • Known Cardiovascular Disease: Consider increased monitoring. ( 5.7 ) 5.1 Serious Rash, including Stevens-Johnson Syndrome Serious rash requiring hospitalization and discontinuation of treatment has been reported in association with the use of modafinil. In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients (age <17 years); these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). The median time to rash that resulted in discontinuation was 13 days. No such cases were observed among 380 pediatric patients who received placebo.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described elsewhere in the labeling: • Serious Rash, including Stevens-Johnson Syndrome [see Warnings and Precautions ( 5.1 )] • Angioedema and Anaphylaxis Reactions [see Warnings and Precautions ( 5.2 )] • Multi-organ Hypersensitivity 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, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 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. Modafinil has been evaluated for safety in over 3,500 patients, of whom more than 2,000 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy.

Use in specific populations

Sourced from openFDA

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies of modafinil in pregnant women. Intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of R- and S-modafinil) and armodafinil (the R-enantiomer of modafinil). Although the pharmacology of modafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class. Certain of these drugs have been associated with intrauterine growth restriction and spontaneous abortions. Whether the cases reported with modafinil are drug-related is unknown. In studies of modafinil and armodafinil conducted in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures. Modafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis caused, in the absence of maternal toxicity, an increase in resorptions and an increased incidence of visceral and skeletal variations in the offspring at the highest dose tested.

Pharmacokinetics

Sourced from openFDA
Metabolism
Modafinil is a 1:1 racemic compound, whose enantiomers have different pharmacokinetics (e.g., the half-life of R-modafinil is approximately three times that of S-modafinil in adult humans). The enantiomers do not interconvert.

Overdosage

Sourced from openFDA

In clinical trials, a total of 151 protocol-specified doses ranging from 1000 to 1600 mg/day (5 to 8 times the recommended daily dose of modafinil) have been administered to 32 subjects, including 13 subjects who received doses of 1000 or 1200 mg/day for 7 to 21 consecutive days. In addition, several intentional acute overdoses occurred; the two largest being 4500 mg and 4000 mg taken by two subjects participating in foreign depression studies. None of these study subjects experienced any unexpected or life-threatening effects. Adverse reactions that were reported at these doses included excitation or agitation, insomnia, and slight or moderate elevations in hemodynamic parameters. Other observed high-dose effects in clinical studies have included anxiety, irritability, aggressiveness, confusion, nervousness, tremor, palpitations, sleep disturbances, nausea, diarrhea, and decreased prothrombin time. From postmarketing experience, there have been reports of fatal overdoses involving modafinil alone or in combination with other drugs.

Approval history

Sourced from openFDA
  • Dec 24, 1998NDANDA020717Nuvo Pharms
  • Sep 26, 2012ANDAANDA078963Orbion Pharms
  • Sep 27, 2012ANDAANDA202566Aurobindo Pharma Ltd
  • Oct 18, 2012ANDAANDA202700Alembic
  • Feb 3, 2014ANDAANDA077667Apotex
  • Aug 16, 2017ANDAANDA207196Appco
  • Sep 14, 2017ANDAANDA209966Cadila

FAERS reports

View JSON
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.
31,871 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. 1Fatigue2,9249.2%
  2. 2Nausea2,2347.0%
  3. 3Drug Ineffective2,1226.7%
  4. 4Headache1,8555.8%
  5. 5Fall1,7775.6%
  6. 6Depression1,6065.0%
  7. 7Anxiety1,4944.7%
  8. 8Somnolence1,4034.4%
  9. 9Dizziness1,3964.4%
  10. 10Pain1,2844.0%
  11. 11Insomnia1,1423.6%
  12. 12Condition Aggravated1,1283.5%
  13. 13Feeling Abnormal1,1123.5%
  14. 14Weight Decreased1,1023.5%
  15. 15Asthenia1,0713.4%

Literature

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Recent PubMed references pinned to Modafinil 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 216 ClinicalTrials.gov registrations naming Modafinil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Modafinil. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2D6CPIC C (provisional)

Frequently asked questions

How does Modafinil work?
The mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of the sympathomimetic amines.
What is Modafinil used for?
According to FDA labeling, Modafinil carries indications including: Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil 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 Modafinil?
Modafinil is classified as Centrally acting sympathomimetics, Sympathomimetic-like Agent, Dopamine Uptake Inhibitors, Central Nervous System Stimulation, Increased Central Nervous System Organized Electrical Activity, Increased Sympathetic Activity.
What are the brand names for Modafinil?
Modafinil is marketed under brand names including Provigil.
What are the contraindications for Modafinil?
Modafinil labeling lists contraindications including: Modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil.. Always consult the full prescribing information and a clinician.
Note. Data for modafinil 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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