Nuvigil Armodafinil 250 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Centrally acting sympathomimetics class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Armodafinil 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). Armodafinil 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 sle...
Read the full MedlinePlus article ↗- It promotes wakefulness, so yes, it has some similarities to stimulants like amphetamine in terms of keeping you alert. But its mechanism is different — it mainly works through the...
- What exactly does armodafinil do — is it like a stimulant?
- For sleep apnea or narcolepsy, take it once in the morning. For shift work disorder, take it about an hour before your shift starts. Food won't significantly change how much of the...
- When should I take it, and does it matter if I eat first?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Armodafinil — tap one for details:
Armodafinil may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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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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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
6 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 | $11.79 | $353.69 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Armodafinil 250 mg 69339-0180-03 | Natco | 30 tablets | $0.901 | AB | FDA listed | — |
| Armodafinil 250 mg 00093-3094-56 | Teva | 30 tablets | $0.923 | AB | Availability likely | — |
| Armodafinil 250 mg 00378-3433-93 | Mylan | 30 tablets | $0.923 | AB | Availability likely | — |
| Armodafinil 250 mg 00781-8053-31 | Sandoz | 30 tablets | $0.923 | AB | Availability likely | — |
| armodafinil 250 mg 63459-0225-30 | Cephalon, | 30 tablets | $34.739 | — | Discontinued | — |
| Nuvigil 250 mg 60505-4850-03 | Apotex | 30 tablets | $34.766 | AB | Availability likely | — |
| Armodafinil 250 mg 55700-0510-30 | Quality | 30 tablets | — | AB | FDA listed | — |
| Nuvigil 250 mgthis 60429-0004-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Armodafinil 250 mg 65862-0807-05 | Aurobindo | 500 tablets | — | AB | FDA listed | — |
| Armodafinil 250 mg 71335-1308-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Armodafinil 250 mg 72189-0133-30 | direct | 30 tablets | — | AB | FDA listed | — |
| Armodafinil 250 mg 72189-0261-30 | direct | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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📊 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 |
|---|---|---|---|
| 60429-0004-30 You're viewing this | 30 TABLET in 1 BOTTLE (60429-004-30) | 2025-07-30 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, NUVIGIL is 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 NUVIGIL for excessive sleepiness.
NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). ( 1 ) Limitations of Use In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dosage of NUVIGIL 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 )
2.1Dosage in Obstructive Sleep Apnea (OSA) and Narcolepsy The recommended dosage of NUVIGIL 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)] .
2.2Dosage in Shift Work Disorder (SWD) The recommended dosage of NUVIGIL 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.
2.3Dosage Modification in Patients with Severe Hepatic Impairment In patients with severe hepatic impairment, the dosage of NUVIGIL should be reduced [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)] .
2.1Dosage in Obstructive Sleep Apnea (OSA) and Narcolepsy The recommended dosage of NUVIGIL 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)] .
2.2Dosage in Shift Work Disorder (SWD) The recommended dosage of NUVIGIL 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.
2.3Dosage Modification in Patients with Severe Hepatic Impairment In patients with severe hepatic impairment, the dosage of NUVIGIL should be reduced [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 50 mg – round, white to off-white tablet with on one side and "205" on the other 150 mg – oval, white to off-white tablet with on one side and "215" on the other 200 mg – rounded, rectangular, white to off-white tablet with on one side and "220" on the other 250 mg – oval, white to off-white tablet with on one side and "225" on the other Tablets: 50 mg, 150 mg, 200 mg, and 250 mg. ( 3 ) stylized c stylized c stylized c stylized c
⛔ Contraindications ▾
4 CONTRAINDICATIONS NUVIGIL 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 )] . NUVIGIL is 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 NUVIGIL at the first sign of rash, unless the rash is clearly not drug-related. ( 5.1 ) DRESS/Multi-organ Hypersensitivity Reactions: if suspected, discontinue NUVIGIL. ( 5.2 ) Angioedema and Anaphylaxis Reactions: if suspected, discontinue NUVIGIL.
( 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 NUVIGIL if psychiatric symptoms develop.
( 5.5 ) Known Cardiovascular Disease: consider increased monitoring. ( 5.7 )
5.1Serious 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 NUVIGIL (armodafinil) or modafinil (the racemic mixture of S- and R-enantiomers). NUVIGIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication. 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/ Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.2)] .
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.
Skin and mouth sores, blistering, and ulceration have been reported with modafinil and NUVIGIL in the postmarketing setting. Recurrence of signs and symptoms of serious dermatologic reactions following rechallenge has been reported in some cases. Rare cases of serious or life-threatening rash, including SJS and toxic epidermal necrolysis (TEN), have been reported in adults and children in worldwide postmarketing experience with modafinil and NUVIGIL.
There are no factors, including duration of therapy, that are known to predict the risk of occurrence or the severity of rash associated with modafinil or NUVIGIL. In cases where the time to onset was reported, serious rash occurred 1 day to 2 months after initiation of treatment, but isolated cases of serious dermatologic reactions have been reported with symptoms beginning after prolonged treatment (e.g., 3 months). Although benign rashes also occur with NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious.
Accordingly, NUVIGIL should be discontinued at the first sign of rash, skin or mouth sores, or blistering or ulceration, 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.
5.2Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity DRESS, also known as multi-organ hypersensitivity, has been reported with NUVIGIL. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present.
This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though rash is not evident. One fatal case of DRESS that occurred in close temporal association (3 weeks)…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 Apotex Corp. 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. NUVIGIL 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 NUVIGIL more frequently than in placebo-treated patients were headache, nausea, dizziness, and insomnia.
The adverse reaction profile was similar across the studies. Table 1 presents the adverse reactions that occurred at a rate of 1% or more and were more frequent in NUVIGIL-treated patients than in placebo-treated patients in the placebo-controlled clinical trials. Table 1: Adverse Reactions in Pooled Placebo-Controlled Clinical Trials* in OSA, Narcolepsy, and SWD with NUVIGIL (150 mg and 250 mg) NUVIGIL (%) N=645 Placebo (%) N=445 * Adverse reactions that occurred in > 1% of NUVIGIL-treated patients and greater incidence than that of placebo.
Headache 17 9 Nausea 7 3 Dizziness 5 2 Insomnia 5 1 Anxiety 4 1 Diarrhea 4 2 Dry Mouth 4 1 Depression 2 0 Dyspepsia 2 0 Fatigue 2 1 Palpitations 2 1 Rash 2 0 Upper Abdominal Pain 2 1 Agitation 1 0 Anorexia 1 0 Constipation 1 0 Contact Dermatitis 1 0 Decreased Appetite 1 0 Depressed Mood 1 0 Disturbance In Attention 1 0 Dyspnea 1 0 Hyperhydrosis 1 0 Increased Gamma-Glutamyltransferase 1 0 Increased Heart Rate 1 0 Influenza-Like Illness 1 0 Loose Stools 1 0 Migraine 1 0 Nervousness 1 0 Pain 1 0 Paresthesia 1 0 Polyuria 1 0 Pyrexia 1 0 Seasonal Allergy 1 0 Thirst 1 0 Tremor 1 0 Vomiting 1 0 Dose-Dependent Adverse Reactions In the placebo-controlled clinical trials which compared doses of 150 mg/day and 250 mg/day of NUVIGIL and placebo, the following adverse reactions were dose-related: headache, rash, depression, dry mouth, insomnia, and nausea.
See Table 2 for additional information. Table 2: Dose-Dependent Adverse Reactions in Pooled Placebo-Controlled Clinical Trials in OSA, Narcolepsy and SWD NUVIGIL 250 mg (%) N=198 NUVIGIL 150 mg (%) N=447 NUVIGIL Combined (%) N=645 Placebo (%) N=445 Headache 23 14 17 9 Nausea 9 6 7 3 Insomnia 6 4 5 1 Dry Mouth 7 2 4 <1 Rash 4 1 2 <1 Depression 3 1 2 <1 Adverse Reactions Resulting in Discontinuation of Treatment In placebo-controlled clinical trials, 44 of the 645 patients (7%) who received NUVIGIL discontinued due to an adverse reaction compared to 16 of the 445 (4%) of patients that received placebo.
The most frequent reason for discontinuation was headache (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 NUVIGIL, but not placebo.
Few patients, however, had GGT or AP elevations outside of the normal range. No differences were apparent in a…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Effects of NUVIGIL 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 NUVIGIL 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 NUVIGIL [see Clinical Pharmacology (12.3)] . The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL 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 NUVIGIL and for one month after discontinuation of NUVIGIL treatment. Blood levels of cyclosporine may be reduced when used with NUVIGIL. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with NUVIGIL.
Effects of NUVIGIL on CYP2C19 Substrates Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by NUVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. Dose reduction of these drugs may be required when these drugs are used concomitantly with NUVIGIL. Warfarin More frequent monitoring of prothrombin times/INR should be considered whenever NUVIGIL is coadministered with warfarin [see Clinical Pharmacology (12.3)] .
Monoamine Oxidase (MAO) Inhibitors Caution should be used when concomitantly administering MAO inhibitors and NUVIGIL. Steroidal contraceptives (e.g., ethinyl estradiol): use alternative or concomitant methods of contraception while taking NUVIGIL and for one month after discontinuation of NUVIGIL 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 Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NUVIGIL during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-866-404-4106. 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal body weight and increased incidences of fetal variations indicative of growth delay at the highest dose, which was also maternally toxic. The highest no-effect dose for embryofetal developmental toxicity in rat (200 mg/kg/day) was associated with a plasma armodafinil exposure (AUC) less than that in humans at the maximum recommended human dose (MRHD) of NUVIGIL (250 mg/day).
Modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis produced an increase in resorptions and an increased incidence of fetal variations at the highest dose tested. The higher no-effect dose for embryofetal developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil AUC less than that in humans at the MRHD of NUVIGIL. However, in a subsequent rat study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed.
In a study in which modafinil (45, 90, or 180 mg/kg/day) was orally administered to pregnant rabbits during organogenesis, embryofetal death was increased at the highest dose. The highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil AUC less than that in humans at the MRHD of NUVIGIL. 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 armodafinil AUC less than that in humans at the MRHD of NUVIGIL.
No effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring.
8.2Lactation Risk Summary There are no data on the presence of armodafinil or its metabolites in human milk, the effects on the breastfed infant, or the effect of this drug on milk production. Modafinil was present in rat milk when animals were dosed during the lactation period. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for armodafinil and any potential adverse effects on the breastfed child from armodafinil or from the underl…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NUVIGIL during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-866-404-4106. 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal body weight and increased incidences of fetal variations indicative of growth delay at the highest dose, which was also maternally toxic. The highest no-effect dose for embryofetal developmental toxicity in rat (200 mg/kg/day) was associated with a plasma armodafinil exposure (AUC) less than that in humans at the maximum recommended human dose (MRHD) of NUVIGIL (250 mg/day).
Modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis produced an increase in resorptions and an increased incidence of fetal variations at the highest dose tested. The higher no-effect dose for embryofetal developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil AUC less than that in humans at the MRHD of NUVIGIL. However, in a subsequent rat study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed.
In a study in which modafinil (45, 90, or 180 mg/kg/day) was orally administered to pregnant rabbits during organogenesis, embryofetal death was increased at the highest dose. The highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma armodafinil AUC less than that in humans at the MRHD of NUVIGIL. 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 armodafinil AUC less than that in humans at the MRHD of NUVIGIL.
No effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Serious rash has been seen in pediatric patients receiving modafinil [see Warnings and Precautions (5.1)] .
🧓 Geriatric Use ▾
8.5Geriatric Use In elderly patients, elimination of armodafinil 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 )].
🆘 Overdosage ▾
10 OVERDOSAGE Fatal overdoses involving modafinil alone or involving NUVIGIL or modafinil in combination with other drugs have been reported in the postmarketing setting. Symptoms most often accompanying NUVIGIL 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 NUVIGIL 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 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. The R- and S-enantiomers have similar pharmacological actions in animals.
Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their 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. Armodafinil is an indirect dopamine receptor agonist; both armodafinil and modafinil bind in vitro to the dopamine transporter and inhibit dopamine reuptake.
For modafinil, 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 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.
Based on nonclinical studies, two major metabolites, acid and sulfone, of modafinil or armodafinil, do not appear to contribute to the CNS-activating properties of the parent compounds.
12.3Pharmacokinetics 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. No time-dependent change in kinetics was observed through 12 weeks of dosing.
Apparent steady state for armodafinil was reached within 7 days of dosing. At steady state, the systemic exposure for armodafinil is 1.8 times the exposure observed after a single dose. The concentration-time profiles of the R-enantiomer following administration of a single-dose of 50 mg NUVIGIL or 100 mg PROVIGIL (modafinil, a 1:1 mixture of R- and S-enantiomers) are nearly superimposable.
However, the C max and AUC 0-∞ , of armodafinil at steady-state were approximately 37% and 70% higher, respectively, following administration of 200 mg NUVIGIL than the corresponding values of modafinil following administration of 200 mg PROVIGIL due to the more rapid clearance of the S-enantiomer (elimination half-life approximately 4 hours) as compared to the R-enantiomer. Absorption NUVIGIL is readily absorbed after oral administration. The absolute oral bioavailability was not determined due to the aqueous insolubility of armodafinil, which precluded intravenous administration.
Peak plasma concentrations are attained at approximately 2 hours in the fasted state. Food effect on the overall bioavailability of NUVIGIL is considered minimal; however, time to reach peak concentration (t max ) may be delayed by approximately 2-4 hours in the fed state. Since the delay in t max is also associated with elevated plasma concentrations later in time, food can potentially affect the onset and time course of pharmacologic action for NUVIGIL.
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🧬 Mechanism of Action ▾
12.1Mechanism of Action 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. The R- and S-enantiomers have similar pharmacological actions in animals.
Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their 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. Armodafinil is an indirect dopamine receptor agonist; both armodafinil and modafinil bind in vitro to the dopamine transporter and inhibit dopamine reuptake.
For modafinil, 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 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.
Based on nonclinical studies, two major metabolites, acid and sulfone, of modafinil or armodafinil, do not appear to contribute to the CNS-activating properties of the parent compounds.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied NUVIGIL ® (armodafinil) Tablets are available as follows: 50 mg: Each round, white to off-white tablet is debossed with on one side and "205" on the other. NDC 60429-001-30 – Bottles of 30 150 mg: Each oval, white to off-white tablet is debossed with on one side and "215" on the other. NDC 60429-002-30 – Bottles of 30 200 mg: Each rounded, rectangular, white to off-white tablet is debossed with on one side and "220" on the other.
NDC 60429-003-30 – Bottles of 30 250 mg: Each oval, white to off-white tablet is debossed with on one side and "225" on the other. NDC 60429-004-30 – Bottles of 30 stylized c stylized c stylized c stylized c
16.2Storage Store at 20 o C - 25 o C (68 o F - 77 o F).
16.1How Supplied NUVIGIL ® (armodafinil) Tablets are available as follows: 50 mg: Each round, white to off-white tablet is debossed with on one side and "205" on the other. NDC 60429-001-30 – Bottles of 30 150 mg: Each oval, white to off-white tablet is debossed with on one side and "215" on the other. NDC 60429-002-30 – Bottles of 30 200 mg: Each rounded, rectangular, white to off-white tablet is debossed with on one side and "220" on the other.
NDC 60429-003-30 – Bottles of 30 250 mg: Each oval, white to off-white tablet is debossed with on one side and "225" on the other. NDC 60429-004-30 – Bottles of 30 stylized c stylized c stylized c stylized c
16.2Storage Store at 20 o C - 25 o C (68 o F - 77 o F).
📋 Description ▾
11 DESCRIPTION NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(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: Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Serious Dermatologic Reactions Advise patients and caregivers about the risk of potentially fatal serious skin reactions. Educate patients about the signs and symptoms that may signal a serious skin reaction.
Instruct patients to discontinue NUVIGIL and consult with their healthcare provider immediately if a skin reaction such as rash, mouth sores, blisters, or peeling skin occurs during treatment with NUVIGIL [see Warnings and Precautions ( 5.1 )]. DRESS/Multi-organ Hypersensitivity Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately [see Warnings and Precautions ( 5.2 )].
Angioedema and Anaphylactic Reactions Advise patients of life-threatening symptoms suggesting anaphylaxis or angioedema (such as hives, difficulty in swallowing or breathing, hoarseness, or swelling of the face, eyes, lips, or tongue) that can occur with NUVIGIL. Instruct them to discontinue NUVIGIL and immediately report these symptoms to their healthcare provider [see Warnings and Precautions ( 5.3 )]. Wakefulness Advise patients that treatment with NUVIGIL will not eliminate their abnormal tendency to fall asleep.
Advise patients that they should not 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 NUVIGIL has been shown to produce levels of wakefulness that permit such activities. Advise patients that NUVIGIL 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).
Psychiatric Symptoms Advise patients to stop taking NUVIGIL and contact their physician right away if they experience, depression, anxiety, or signs of psychosis or mania. Pregnancy Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NUVIGIL during pregnancy [see Use in Specific Populations ( 8.1 )]. Females of Reproductive Potential Caution females regarding the potential increased risk of pregnancy when using hormonal contraceptives (including depot or implantable contraceptives) with NUVIGIL and advise females who are using a hormonal method of contraception to use an additional barrier method or an alternative non-hormonal method of contraception during treatment with NUVIGIL and for one month after discontinuation of NUVIGIL.
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 NUVIGIL and other drugs. Alcohol Advise patients that the use of NUVIGIL in combination with alcohol has not been studied. Advise patients that it is prudent to avoid alcohol while taking NUVIGIL.
Dispense with Medication Guide available at https://www.apotex.com/products/us/mg.asp .
💬 Medication Guide ▾
MEDICATION GUIDE NUVIGIL (nu-vij-el) (armodafinil) tablets, for oral use, C-IV Medication Guide available at https://www.apotex.com/products/us/mg.asp Read this Medication Guide before you start taking NUVIGIL 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 NUVIGIL? NUVIGIL is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep NUVIGIL in a safe place to prevent misuse and abuse.
Selling or giving away NUVIGIL 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. NUVIGIL 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 NUVIGIL 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, breathing, or hoarseness fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of theeyes, or dark urine. If you have a severe rash with NUVIGIL, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.
NUVIGIL is not approved for use in children for any medical condition. It is not known if NUVIGIL is safe and effective in children under the age of 18. What is NUVIGIL?
NUVIGIL is 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). NUVIGIL is used with other medical treatments for this sleep disorder NUVIGIL does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition. It is important that you continue to use these treatments as prescribed by your doctor. shift work disorder (SWD) NUVIGIL will not cure these sleep disorders.
NUVIGIL may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. NUVIGIL does not take the place of getting enough sleep. Follow your doctor's advice about good sleep habits and using other treatments.
Do not take NUVIGIL: are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in NUVIGIL. have had a rash or allergic reaction to either armodafinil (NUVIGIL) or modafinil (PROVIGIL®). These medicines are very similar.
Before you take NUVIGIL, 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 NUVIGIL. have liver or kidney problemshave a history of drug or alcohol abuse or addiction are pregnant or planning to become pregnant. It is not known if NUVIGIL will harm your unborn baby.
Pregnancy Registry : There is a registry for women who become pregnant during treatment with NUVIGIL. The purpose of this registry is to collect information about the safety of NUVIGIL during pregnancy. Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you.
You or your doctor can get information and enroll you in the registry by calling 1-866-404- 4106. are breastfeeding. It is not known if NUVIGIL passes into your milk. Talk to your doctor about the best way to feed your baby if you take NUVIGIL.
Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and her…