Mediclarum
Medicine guide

Modafinil

200 mg · Tablet

  • Prescription only
  • Controlled substance · CIV
  • Sympathomimetic-like Agent
Active substance
Modafinil
Made by
Major Pharmaceuticals

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-03-11

What it is

Sympathomimetic-like Agent

Used for
  • 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).
The label’s usual adult dose

Narcolepsy or OSA: 200 mg once a day in the morning. ( 2.1 )

Full directions ↓
Do not take it if

Modafinil 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 )] .

All warnings ↓
Good to know
  • Prescription only
  • Controlled substance (schedule IV) — extra rules apply to prescribing and refills
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
41other products contain Modafinil — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • 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.
  • If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.
  • 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).
  • ( 1 ) Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

From the official label · 2025-03-11 · DailyMed

How it works

From this product’s own US prescribing label.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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.

Peak level after2–4 h
Half-life15 h
Mostly cleared after≈ 3 daysfive half-lives — our arithmetic
PeakHalf gone3 days0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

Metabolism and Elimination The major route of elimination is metabolism (approximately 90%), primarily by the liver, with subsequent renal elimination of the metabolites.

With food

Food has no effect on overall modafinil tablets bioavailability; however, time to reach peak concentration (t max ) may be delayed by approximately one hour if taken with food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-03-11

Do not take it if

  • Modafinil 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 )] .
  • Modafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil.
  • ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 )] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Discontinue modafinil tablets at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 )
  • If suspected, discontinue modafinil tablets. ( 5.2 )
  • If suspected, discontinue modafinil tablets. ( 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 tablets 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. Modafinil tablets are not approved for use in pediatric patients for any indication [see Use in Specific Populations ( 8.4 )] . Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in
  • adults and children in worldwide postmarketing experience. The reporting rate of TEN and SJS associated with modafinil use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate. Estimates of the background incidence rate for these serious skin reactions in the general population range between 1 to 2 cases per million-person years. There are no factors that are known to predict the risk of occurrence or the severity of rash associated with modafinil tablets. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation. However, isolated cases have been reported after prolonged treatment (e.g., 3 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes also occur with modafinil tablets, it is not possible to reliably predict which rashes will prove to be serious. Accordingly, modafinil tablets should be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring. 5.2 Angioedema and Anaphylaxis Reactions Angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm), were observed in patients treated with armodafinil, the R enantiomer of modafinil (which is the racemic mixture). No such cases were observed in modafinil clinical trials. However, angioedema has been reported in postmarketing experience with modafinil. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness). 5.3 Multi-organ Hypersensitivity Reactions Multi-organ hypersensitivity reactions, including at least one fatality in postmarketing experience, have occurred in close temporal association (median time to detection 13 days:
  • range 4 to 33) to the initiation of modafinil. Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, hematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia. Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur. If a multi-organ hypersensitivity reaction is suspected, modafinil tablets should be discontinued. Although there are no case reports to indicate cross-sensitivity with other drugs that produce this syndrome, the experience with drugs associated with multi-organ hypersensitivity would indicate this to be a possibility. 5.4 Persistent Sleepiness Patients with abnormal levels of sleepiness who take modafinil tablets should be advised that their level of wakefulness may not return to normal. Patients with excessive sleepiness, including those taking modafinil tablets, should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to
  • avoid driving or any other potentially dangerous activity. Prescribers should also be aware that patients may not acknowledge sleepiness or drowsiness until directly questioned about drowsiness or sleepiness during specific activities. 5.5 Psychiatric Symptoms Psychiatric adverse reactions have been reported in patients treated with modafinil. In the adult modafinil tablets controlled trials, psychiatric symptoms resulting in treatment discontinuation (at a frequency ≥0.3%) and reported more often in patients treated with modafinil tablets compared to those treated with placebo were anxiety (1%), nervousness (1%), insomnia (<1%), confusion (<1%), agitation (<1%), and depression (<1%). Postmarketing adverse reactions associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation, and aggression, some resulting in hospitalization. Many, but not all, patients had a prior psychiatric history. One healthy male volunteer developed ideas of reference, paranoid delusions, and auditory hallucinations in association with multiple daily 600 mg doses of modafinil tablets (three times the recommended dose) and sleep deprivation. There was no evidence of psychosis 36 hours after drug discontinuation. Caution should be exercised when modafinil tablets are given to patients with a history of psychosis, depression, or mania. Consideration should be given to the possible emergence or exacerbation of psychiatric symptoms in patients treated with modafinil tablets. If psychiatric symptoms develop in association with modafinil tablets administration, consider discontinuing modafinil tablets. 5.6 Effects on Ability to Drive and Use Machinery Although modafinil tablets have not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until it is reasonably certain that modafinil tablets therapy will not adversely affect their ability to engage in such activities. 5.7 Cardiovascular Events In modafinil clinical studies, cardiovascular adverse reactions, including chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG occurred in three subjects in association with mitral valve prolapse or left ventricular hypertrophy. In a Canadian clinical trial, a 35 year old obese narcoleptic male with a prior history of syncopal episodes experienced a 9-second episode of asystole after 27 days of modafinil treatment (300 mg/day in divided doses). Modafinil tablets are not recommended in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants. Findings suggestive of mitral valve prolapse syndrome include but are not limited to ischemic ECG changes, chest pain, or arrhythmia. If new onset of any of these findings occurs, consider cardiac evaluation. Consider increased monitoring in patients with a recent history of myocardial infarction or unstable angina. Blood pressure monitoring in short term (≤ 3 months) controlled trials showed no clinically significant changes in mean systolic and diastolic blood pressure in patients receiving modafinil tablets as compared to placebo. However, a retrospective analysis of the use of antihypertensive medication in these studies showed that a greater proportion of patients on modafinil tablets required new or increased use of antihypertensive medications (2.4%) compared to patients on placebo (0.7%). The differential use was slightly larger when only studies in OSA were included, with 3.4% of patients on modafinil tablets and 1.1% of patients on placebo requiring such alterations in the use of antihypertensive medication. Increased monitoring of heart rate and blood pressure may be appropriate in patients on modafinil tablets. Caution should be exercised when prescribing modafinil tablets to patients with known cardiovascular disease.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm.
  • ( 8.1 )
  • 8.1 Pregnancy 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 tablets 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.
  • The higher no-effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) was associated with a plasma modafinil AUC less than that in humans at the recommended human dose (RHD) of modafinil tablets (200 mg/day).
  • However, in a subsequent study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed.
  • Oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in increased incidences of fetal visceral and skeletal variations and decreased fetal body weight at the highest dose tested.
  • The highest no-effect dose for embryofetal developmental toxicity in rats (200 mg/kg/day) was associated with a plasma armodafinil AUC less than that in humans at the RHD of modafinil tablets.
  • Modafinil administered orally to pregnant rabbits throughout organogenesis at doses of up to 100 mg/kg/day had no effect on embryofetal development; however, the doses used were too low to adequately assess the effects of modafinil on embryofetal development.
  • In a subsequent developmental toxicity study evaluating doses of 45, 90, and 180 mg/kg/day in pregnant rabbits, the incidences of fetal structural alterations and embryofetal death were increased at the highest dose.
  • The highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma modafinil AUC similar to that in humans at the RHD of modafinil tablets.
  • Modafinil administration to rats throughout gestation and lactation at oral doses of up to 200 mg/kg/day resulted in decreased viability in the offspring at doses greater than 20 mg/kg/day, a dose resulting in a plasma modafinil AUC less than that in humans at the RHD of modafinil tablets.
  • No effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring.
  • 8.3 Nursing Mothers It is not known whether modafinil or its metabolites are excreted in human milk.
  • Because many drugs are excreted in human milk, caution should be exercised when modafinil tablets are administered to a nursing woman.
  • 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
  • Modafinil tablets are not approved in this population for any indication.
  • Serious skin rashes, including erythema multiforme major (EMM) and Stevens-Johnson Syndrome (SJS) have been associated with modafinil use in pediatric patients [see Warnings and Precautions ( 5.1 )] .
  • In a controlled 6-week study, 165 pediatric patients (aged 5 to 17 years) with narcolepsy were treated with modafinil (n=123), or placebo (n=42).
  • There were no statistically significant differences favoring modafinil over placebo in prolonging sleep latency as measured by MSLT, or in perceptions of sleepiness as determined by the clinical global impression-clinician scale (CGI-C).
  • In the controlled and open-label clinical studies, treatment emergent adverse reactions of the psychiatric and nervous system included Tourette’s syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations, and suicidal ideation.
  • Transient leukopenia, which resolved without medical intervention, was also observed.
  • In the controlled clinical study, 3 of 38 girls, ages 12 or older, treated with modafinil experienced dysmenorrhea compared to 0 of 10 girls who received placebo.
  • There were three 7 to 9 week, double-blind, placebo-controlled, parallel group studies in children and adolescents (aged 6 to 17 years) with Attention-Deficit Hyperactivity Disorder (ADHD).
  • Two of the studies were flexible-dose studies (up to 425 mg/day), and the third was a fixed-dose study (340 mg/day for patients <30 kg and 425 mg/day for patients ≥30 kg).
  • Although these studies showed statistically significant differences favoring modafinil over placebo in reducing ADHD symptoms as measured by the ADHD-RS (school version), there were 3 cases of serious rash including one case of possible SJS among 933 patients exposed to modafinil in this program.
  • Modafinil is not approved for use in treating ADHD.
  • 8.5 Geriatric Use In clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups.
  • In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging.
  • Therefore, consideration should be given to the use of lower doses and close monitoring in this population [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )] .
  • 8.6 Hepatic Impairment In patients with severe hepatic impairment, the dose of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Effects of Modafinil Tablets on CYP3A4/5 Substrates The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by modafinil tablets via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with modafinil tablets [see Clinical Pharmacology ( 12.3 )] . The effectiveness of steroidal contraceptives may be reduced when used with modafinil tablets and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with modafinil tablets and for one month after discontinuation of modafinil tablets treatment. Blood levels of cyclosporine may be reduced when used with modafinil tablets. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with modafinil tablets. Effects of Modafinil Tablets on CYP2C19 Substrates Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by modafinil tablets via inhibition of metabolic enzymes, with resultant higher systemic exposure. In individuals deficient in the CYP2D6 enzyme, the levels of CYP2D6 substrates which have ancillary routes of elimination through CYP2C19, such as tricyclic antidepressants and selective serotonin reuptake inhibitors, may be increased by co-administration of modafinil tablets. Dose adjustments of these drugs and other drugs that are substrates for CYP2C19 may be necessary when used concomitantly with modafinil tablets [see Clinical Pharmacology ( 12.3 )] . Warfarin More frequent monitoring of prothrombin times/INR should be considered whenever modafinil tablets are coadministered with warfarin [see Clinical Pharmacology ( 12.3 )] . Monoamine Oxidase (MAO) Inhibitors Caution should be used when concomitantly administering MAO inhibitors and modafinil tablets.
  • Steroidal contraceptives (e.g., ethinyl estradiol):
  • Use alternative or concomitant methods of contraception while taking modafinil tablets and for one month after discontinuation of modafinil tablets treatment. ( 7 )
  • Cyclosporine: Blood concentrations of cyclosporine may be reduced. ( 7 )
  • CYP2C19 substrates, such as omeprazole, phenytoin, and diazepam:
  • Exposure of these medications may be increased. ( 7 )

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • 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 tablets) 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.
  • Symptoms most often accompanying modafinil tablets overdose, alone or in combination with other drugs have included insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, agitation, anxiety, excitation, and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.
  • Cases of accidental ingestion/overdose have been reported in children as young as 11 months of age.
  • The highest reported accidental ingestion on a mg/kg basis occurred in a three-year-old boy who ingested 800 to 1000 mg (50 to 63 mg/kg) of modafinil tablets.
  • The child remained stable.
  • The symptoms associated with overdose in children were similar to those observed in
  • adults.
  • No specific antidote exists for the toxic effects of a modafinil tablets overdose.
  • Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

  • 9.1 Controlled Substance Modafinil tablets contain modafinil, a Schedule IV controlled substance.
  • 9.2 Abuse In humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants.
  • In in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release.
  • Modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine.
  • In some studies, modafinil was also partially discriminated as stimulant-like.
  • Physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse.
  • Patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior).
  • The abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse.
  • Results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants (methylphenidate).
  • 9.3 Dependence In one placebo-controlled clinical trial, the effects of modafinil withdrawal were monitored following 9 weeks of modafinil use.
  • There were no reported withdrawal symptoms with modafinil during 14 days of observation, although sleepiness returned in narcoleptic patients.

Quoted from the official label, section “Drug Abuse and Dependence”.

Side effects

  • 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 Apotex Corp., Drug Safety at 1-800-706-5575 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 tablets have 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. Most Common Adverse Reactions In placebo-controlled clinical trials, the most common adverse reactions (≥ 5%) associated with the use of modafinil tablets more frequently than placebo-treated patients were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse reaction profile was similar across these studies. Table 1 presents the adverse reactions that occurred at a rate of 1% or more and were more frequent in modafinil tablets-treated patients than in placebo-treated patients in the placebo-controlled clinical trials. Table 1. Adverse Reactions in Pooled Placebo-Controlled Trials* in Narcolepsy, OSA, and SWD Modafinil tablets (%) (n = 934) Placebo (%) (n = 567) Headache 34 23 Nausea 11 3 Nervousness 7 3 Rhinitis 7 6 Back Pain 6 5 Diarrhea 6 5 Anxiety 5 1 Dizziness 5 4 Dyspepsia 5 4 Insomnia 5 1 Anorexia 4 1 Dry Mouth 4 2 Pharyngitis 4 2 Chest Pain 3 1 Hypertension 3 1 Abnormal Liver Function 2 1 Constipation 2 1 Depression 2 1 Palpitation 2 1 Paresthesia 2 0 Somnolence 2 1 Tachycardia 2 1 Vasodilatation 2 0 Abnormal Vision 1 0 Agitation 1 0 Asthma 1 0 Chills 1 0 Confusion 1 0 Dyskinesia 1 0 Edema 1 0 Emotional Lability 1 0 Eosinophilia 1 0 Epistaxis 1 0 Flatulence 1 0 Hyperkinesia 1 0 Hypertonia 1 0 Mouth Ulceration 1 0 Sweating 1 0 Taste Perversion 1 0 Thirst 1 0 Tremor 1 0 Urine Abnormality 1 0 Vertigo 1 0 * Adverse Reactions that occurred in ≥1% of modafinil tablets-treated patients (either 200, 300, or 400 mg once daily) and greater incidence than placebo Dose-Dependent Adverse Reactions In the placebo-controlled clinical trials which compared doses of 200, 300, and 400 mg/day of modafinil tablets and placebo, the following adverse reactions were dose related:
  • headache and anxiety. Adverse Reactions Resulting in Discontinuation of Treatment In placebo-controlled clinical trials, 74 of the 934 patients (8%) who received modafinil tablets discontinued due to an adverse reaction compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for modafinil tablets than placebo patients were headache (2%), nausea, anxiety, dizziness, insomnia, chest pain, and nervousness (each <1%). Laboratory Abnormalities Clinical chemistry, hematology, and urinalysis parameters were monitored in the studies. Mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of modafinil tablets, but not placebo. Few patients, however, had GGT or AP elevations outside of the normal range. Shifts to higher, but not clinically significantly abnormal, GGT and AP values appeared to increase with time in the population treated with modafinil tablets in the placebo- controlled clinical trials. No differences were apparent in alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, or total bilirubin. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of modafinil tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hematologic:
  • agranulocytosis Psychiatric disorders:
  • psychomotor hyperactivity

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Allergic Reactions Advise patients to stop taking modafinil tablets and to notify their physician right away if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing, or a related allergic phenomenon.
  • Driving and Dangerous Activities Advise patients not to alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with modafinil tablets have been shown to produce levels of wakefulness that permit such activities.
  • Advise patients that modafinil tablet is not a replacement for sleep.
  • Continuing Previously Prescribed Treatments Inform patients that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSA receiving CPAP should continue to do so).
  • Discontinuing Drug Due to Adverse Reactions Advise patients to stop taking modafinil tablets and contact their physician right away if they experience chest pain, rash, depression, anxiety, or signs of psychosis or mania.
  • Pregnancy Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy.
  • Caution patients regarding the potential increased risk of pregnancy
  • when using steroidal contraceptives (including depot or implantable contraceptives) with modafinil tablets and for one month after discontinuation of therapy.
  • Nursing Advise patients to notify their physician if they are breastfeeding an infant.
  • Concomitant Medication Advise patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, because of the potential for interactions between modafinil tablets and other drugs.
  • Alcohol Advise patients that the use of modafinil tablets in combination with alcohol has not been studied.
  • Advise patients that it is prudent to avoid alcohol while taking modafinil tablets.
  • Dispense with Medication Guide available at www1.apotex.com/products/us APOTEX INC.
  • MODAFINIL TABLETS, USP 100 mg and 200 mg Manufactured by Manufactured for Apotex Inc.
  • Apotex Corp.
  • Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Packaged and Distributed by:
  • MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Revised:
  • January 2022 Rev. 10

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS 100 mg – White, round, biconvex tablets, engraved "MOD" over "100" on one side, "APO" on the other side. 200 mg – White, oval, biconvex tablets, scored and engraved "MOD" bisect "200" on one side, "APO" on the other side.
  • Tablets: 100 mg and 200 mg.
  • ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • 16.1 How Supplied Modafinil Tablets, USP are supplied as follows:
  • 100 mg White, round, biconvex tablets, engraved "MOD" over "100" on one side, "APO" on the other side.
  • Cartons of 30 tablets (10 tablets each blister pack x 3), NDC 0904-6791-04 200 mg White, oval, biconvex tablets, scored and engraved "MOD" bisect "200" on one side, "APO" on the other side.
  • Cartons of 30 tablets (10 tablets each blister pack x 3), NDC 0904-6792-04
  • Storage
  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
  • Dispense in tight, light-resistant container [see USP].

Quoted from the official label, section “How Supplied”.

What is in it

  • Modafinil, USP is a wakefulness-promoting agent for oral administration.
  • Modafinil, USP is a racemic compound.
  • The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide.
  • The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35.
  • The chemical structure is:
  • Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane.
  • It is sparingly to slightly soluble in methanol and acetone.
  • Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients:
  • colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose.
  • Modafinil Tablets meet USP Dissolution Test 3. modafinil-01.jpg

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (21)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Showing 21 of 21

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

FranceNo exact match for this strength and form

Every strength and form (8)

CanadaNo exact match for this strength and form

Every strength and form (9)

Netherlands2 matching products

Every strength and form (7)

Details

Made byMajor Pharmaceuticals
Active substanceModafinil
Strength200 mg
FormTablet
RouteOral
Packs30 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
NDC0904-6792

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

36 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Modafinil100 mgPrescription onlyTablet Major Pharmaceuticals · ModafinilModafinil100 mgPrescription onlyTablet Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · ModafinilModafinil200 mgPrescription onlyTablet Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · ModafinilModafinil200 mgPrescription onlyTablet Aphena Pharma Solutions - Tennessee, LLC · ModafinilModafinil100 mgPrescription onlyTablet Alembic Pharmaceuticals Limited · ModafinilModafinil200 mgPrescription onlyTablet Alembic Pharmaceuticals Limited · Modafinil

See every product with Modafinil