Modafinil 100 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Sympathomimetic-like Agent class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Modafinil is used to treat excessive sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) or shift work sleep disorder (sleepiness during scheduled waking hours and difficulty falling asleep or staying asleep during scheduled sleeping hours in people who work at night or on rotating shifts). Modafinil is also used along with breathing devices or other treatments to prevent excessive sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep a...
Read the full MedlinePlus article ↗- Modafinil helps you stay awake and reduces the excessive daytime sleepiness that comes with narcolepsy, obstructive sleep apnea, or shift work disorder. It doesn't cure any of thes...
- What exactly is modafinil supposed to do for me?
- If you have narcolepsy or sleep apnea, take your tablet in the morning. If you use it for shift work disorder, take it about an hour before your shift starts. The label doesn't req...
- When should I take it — and does it matter if I take it with food?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Modafinil — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII NPU9M2E6L8
Methylcellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and a viscosity builder in liquid formulations.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.242 | $7.26 / 30 tablet |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.5456 | $16.37 / 30 tablet |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Modafinil 100 mgthis 00904-6791-04 | Major | 30 tablets | $0.242 | AB | Availability likely | — |
| Modafinil 100 mg 50268-0570-12 | AvPAK | 20 tablets | $0.242 | AB | Availability likely | — |
| Modafinil 100 mg 55253-0801-30 | CIMA | 30 tablets | $0.242 | AB | Availability likely | — |
| Modafinil 100 mg 60505-2526-01 | Apotex | 100 tablets | $0.242 | AB | Availability likely | — |
| Modafinil 100 mg 65862-0601-01 | Aurobindo | 100 tablets | $0.242 | AB | Availability likely | — |
| Modafinil 100 mg 68084-0621-21 | American | 30 tablets | $0.242 | AB | Availability likely | — |
| Modafinil 100 mg 69452-0342-13 | Bionpharma | 30 tablets | $0.242 | AB | Availability likely | — |
| Provigil 100 mg 63459-0101-30 | Cephalon, | 30 tablets | $53.153 | AB | Availability likely | +21868% |
| Modafinil 100 mg 23155-0604-01 | Heritage | 100 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 46708-0385-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 51407-0928-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 51407-0960-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 57237-0154-01 | Rising | 100 tablets | — | AB | FDA listed | — |
| Provigil 100 mg 60429-0009-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Provigil 100 mg 60505-4851-07 | Apotex | 32000 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 62332-0385-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 68071-5121-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 70771-1051-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 71205-0477-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 71335-1122-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 71610-0976-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Modafinil 100 mg 72578-0005-01 | Viona | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00904-6791-04 You're viewing this | 30 BLISTER PACK in 1 CARTON (0904-6791-04) / 1 TABLET in 1 BLISTER PACK | 2014-02-03 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 )
2.1Dosage 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 )] .
2.2Dosage 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.
2.3Dosage 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 )] .
2.4Use 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 )] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE 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 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Serious Rash, including Stevens-Johnson Syndrome: Discontinue modafinil tablets at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) • Angioedema and Anaphylaxis Reactions: If suspected, discontinue modafinil tablets. ( 5.2 ) • Multi-organ Hypersensitivity Reactions: 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 )
5.1Serious 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.
5.2Angioedema 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).
5.3Multi-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…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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
6.1Clinical 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. Shif…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.1Pregnancy 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.
8.3Nursing 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.
8.4Pediatric 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 prolo…
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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. Modafinil-induced wakefulness can be attenuated by the α1-adrenergic receptor antagonist, prazosin; however, modafinil is inactive in other in vitro assay systems known to be responsive to α-adrenergic agonists such as the rat vas deferens preparation.
Modafinil is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro , modafinil binds to the dopamine transporter and inhibits dopamine reuptake. This activity has been associated in vivo with increased extracellular dopamine levels in some brain regions of animals.
In genetically engineered mice lacking the dopamine transporter (DAT), modafinil lacked wake-promoting activity, suggesting that this activity was DAT-dependent. However, the wake-promoting effects of modafinil, unlike those of amphetamine, were not antagonized by the dopamine receptor antagonist haloperidol in rats. In addition, alpha-methyl-p-tyrosine, a dopamine synthesis inhibitor, blocks the action of amphetamine, but does not block locomotor activity induced by modafinil.
In the cat, equal wakefulness-promoting doses of methylphenidate and amphetamine increased neuronal activation throughout the brain. Modafinil at an equivalent wakefulness-promoting dose selectively and prominently increased neuronal activation in more discrete regions of the brain. The relationship of this finding in cats to the effects of modafinil in humans is unknown.
In addition to its wake-promoting effects and ability to increase locomotor activity in animals, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans. Modafinil has reinforcing properties, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine; modafinil was also partially discriminated as stimulant-like. The optical enantiomers of modafinil have similar pharmacological actions in animals.
Two major metabolites of modafinil, modafinil acid and modafinil sulfone, do not appear to contribute to the CNS-activating properties of modafinil.
12.3Pharmacokinetics 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. At steady state, total exposure to R-modafinil is approximately three times that for S-modafinil.
The trough concentration (C min,ss ) of circulating modafinil after once daily dosing consists of 90% of R-modafinil and 10% of S-modafinil. The effective elimination half-life of modafinil after multiple doses is about 15 hours. The enantiomers of modafinil exhibit linear kinetics upon multiple dosing of 200 to 600 mg/day once daily in healthy volunteers.
Apparent steady states of total modafinil and R-modafinil are reached after 2 to 4 days of dosing. Absorption Modafinil tablet is readily absorbed after oral administration, with peak plasma concentrations occurring at 2 to 4 hours. The bioavailability of modafinil tablets is approximately equal to that of an aqueous suspension.
The absolute oral bioavailability was not determined due to the aqueous insolubility (<1 mg/mL) of modafinil, which precluded intravenous administration. 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. Distribution Modafinil tablets have an apparent volume of distribution of approximately
0.9L/kg. In human plasma, in vitro , modafinil is moderately bound to plasma protein (approximately 60%), mainly to albumin. The p…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How 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
16.2Storage 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].
📋 Description ▾
11 DESCRIPTION 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
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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
💬 Medication Guide ▾
Medication Guide Modafinil Tablets, USP 100 mg and 200 mg (moe daf' i nil) Rx Only Medication Guide available at www1.apotex.com/products/us Read this Medication Guide before you start taking modafinil tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about modafinil tablets? Modafinil tablets may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening.
Stop taking modafinil tablets and call your doctor right away or get emergency help if you have any of these symptoms: • skin rash, hives, sores in your mouth, or your skin blisters and peels • swelling of your face, eyes, lips, tongue, or throat • trouble swallowing or breathing • fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine. If you have a severe rash with modafinil tablets, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.
Modafinil tablets are not approved for use in children for any medical condition. It is not known if modafinil tablets are safe or effective in children under 17 years of age. What are modafinil tablets?
Modafinil tablets are a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders: • narcolepsy • obstructive sleep apnea (OSA). Modafinil tablets are used to treat excessive sleepiness, but not the obstruction or medical condition that is causing OSA. You should talk with your doctor about treatments for OSA before you start taking modafinil tablets and during treatment with modafinil tablets.
Modafinil tablets do not take the place of treatments that your doctor has prescribed for OSA. It is important that you continue to use these treatments as prescribed by your doctor. • shift work disorder (SWD) Modafinil tablets will not cure these sleep disorders. Modafinil tablets may help the sleepiness caused by these conditions, but it may not stop all your sleepiness.
Modafinil tablets do not take the place of getting enough sleep. Follow your doctor’s advice about good sleep habits and using other treatments. Modafinil is a federally controlled substance (C-IV) because it can be abused or lead to dependence.
Keep modafinil tablets in a safe place to prevent misuse and abuse. Selling or giving away modafinil tablets may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take modafinil tablets? Do not take modafinil tablets if you: • are allergic or developed a rash to modafinil or armodafinil (NUVIGIL ® ) or any of the ingredients in modafinil tablets. See the end of this Medication Guide for a complete list of ingredients in modafinil tablets.
What should I tell my doctor before taking modafinil tablets? Tell your doctor about all of your medical conditions including, if you: • have a history of mental health problems, including psychosis • have heart problems or had a heart attack • have high blood pressure. Your blood pressure may need to be checked more often while taking modafinil tablets. • have liver or kidney problems • have a history of drug or alcohol abuse or addiction • are pregnant or planning to become pregnant.
It is not known if modafinil will harm your unborn baby. • are breastfeeding. It is not known if modafinil passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take modafinil tablets.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplemen…