Nuvigil

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Side Effects & Adverse Reactions

Serious Rash, including Stevens-Johnson Syndrome

Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of modafinil.

Armodafinil 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 (a racemic mixture of S and R enantiomers), 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. No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil. 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 post-marketing experience with modafinil. 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.

No serious skin rashes have been reported in adult clinical trials (0 per 1,595) of armodafinil. However, cases of serious rash similar to those observed with modafinil including skin and mouth blistering have been reported in adults in postmarketing experience.

There are no factors that are known to predict the risk of occurrence or the severity of rash associated with armodafinil or modafinil. Nearly all cases of serious rash associated with these drugs occurred within 1 to 5 weeks after treatment initiation. However, isolated cases have been reported after prolonged treatment with modafinil (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 armodafinil, it is not possible to reliably predict which rashes will prove to be serious. Accordingly, armodafinil should ordinarily 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.

Angioedema and Anaphylactoid Reactions

One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm), were observed among 1,595 patients treated with armodafinil. 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).

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 4-33) to the initiation of modafinil. A similar risk of multi-organ hypersensitivity reactions with armodafinil cannot be ruled out.

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 associated with modafinil. 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, NUVIGIL 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.

Persistent Sleepiness

Patients with abnormal levels of sleepiness who take NUVIGIL should be advised that their level of wakefulness may not return to normal. Patients with excessive sleepiness, including those taking NUVIGIL, 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.

Psychiatric Symptoms

Psychiatric adverse experiences have been reported in patients treated with modafinil. Modafinil and armodafinil (NUVIGIL) are very closely related. Therefore, the incidence and type of psychiatric symptoms associated with armodafinil are expected to be similar to the incidence and type of these events with modafinil.

Postmarketing adverse events 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 and sleep deprivation. There was no evidence of psychosis 36 hours after drug discontinuation.

In the controlled trial NUVIGIL database, anxiety, agitation, nervousness, and irritability were reasons for treatment discontinuation more often in patients on NUVIGIL compared to placebo (NUVIGIL 1.2% and placebo 0.3%). In the NUVIGIL controlled studies, depression was also a reason for treatment discontinuation more often in patients on NUVIGIL compared to placebo (NUVIGIL 0.6% and placebo 0.2%). Two cases of suicide ideation were observed in clinical trials. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. If psychiatric symptoms develop in association with NUVIGIL administration, consider discontinuing NUVIGIL.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

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Uses

NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy and shift work disorder.

In OSA, NUVIGIL is indicated as an adjunct to standard treatment(s) 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. If NUVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.

In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

The effectiveness of NUVIGIL in long-term use (greater than 12 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe NUVIGIL for an extended time in patients should periodically re-evaluate long-term usefulness for the individual patient.

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History

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Other Information

NUVIGIL® (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.

The chemical structure is:

Armodafinil exists in multiple crystalline forms. Form I, which is used in NUVIGIL, is the least soluble form of armodafinil and is a white to off-white, crystalline powder that is very slightly soluble in water, sparingly soluble in acetone and soluble in methanol. At least 90% of the armodafinil particles used in NUVIGIL have a diameter less than 200 microns.

NUVIGIL tablets contain 50 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

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Nuvigil Manufacturers

Kaiser Foundation Hospitals

Nuvigil | Kaiser Foundation Hospitals

Obstructive Sleep Apnea (OSA) and Narcolepsy

The recommended dose of NUVIGIL for patients with OSA or narcolepsy is 150 mg or 250 mg given 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 this dose confers additional benefit beyond that of the 150 mg/day dose (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).

Shift Work Sleep Disorder (SWD)

The recommended dose of NUVIGIL for patients with SWD is 150 mg given daily approximately 1 hour prior to the start of their work shift.

Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4/5, such as steroidal contraceptives, triazolam, and cyclosporine (See PRECAUTIONS, Drug Interactions).

Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with NUVIGIL and may require dosage reduction and monitoring for toxicity (See PRECAUTIONS, Drug Interactions).

In patients with severe hepatic impairment, NUVIGIL should be administered at a reduced dose (See CLINICAL PHARMACOLOGYand PRECAUTIONS).

There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGYand PRECAUTIONS).

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 in this population (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

No Recall
Rebel Distributors Corp

Nuvigil | Rebel Distributors Corp

Obstructive Sleep Apnea (OSA) and Narcolepsy

The recommended dose of NUVIGIL for patients with OSA or narcolepsy is 150 mg or 250 mg given 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 this dose confers additional benefit beyond that of the 150 mg/day dose (See CLINICAL PHARMACOLOGY andCLINICAL TRIALS).

Shift Work Sleep Disorder (SWD)

The recommended dose of NUVIGIL for patients with SWD is 150 mg given daily approximately 1 hour prior to the start of their work shift.

Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4/5, such as steroidal contraceptives, triazolam, and cyclosporine (See PRECAUTIONS, Drug Interactions).

Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with NUVIGIL and may require dosage reduction and monitoring for toxicity (See PRECAUTIONS, Drug Interactions).

In patients with severe hepatic impairment, NUVIGIL should be administered at a reduced dose (See CLINICAL PHARMACOLOGYandPRECAUTIONS).

There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (SeeCLINICAL PHARMACOLOGYandPRECAUTIONS).

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 in this population (See CLINICAL PHARMACOLOGY andPRECAUTIONS).

No Recall
Stat Rx Usa Llc

Nuvigil | Stat Rx Usa Llc

Obstructive Sleep Apnea (OSA) and Narcolepsy

The recommended dose of NUVIGIL for patients with OSA or narcolepsy is 150 mg or 250 mg given 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 this dose confers additional benefit beyond that of the 150 mg/day dose (See CLINICAL PHARMACOLOGY andCLINICAL TRIALS).

Shift Work Sleep Disorder (SWD)

The recommended dose of NUVIGIL for patients with SWD is 150 mg given daily approximately 1 hour prior to the start of their work shift.

Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4/5, such as steroidal contraceptives, triazolam, and cyclosporine (See PRECAUTIONS, Drug Interactions).

Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with NUVIGIL and may require dosage reduction and monitoring for toxicity (See PRECAUTIONS, Drug Interactions).

In patients with severe hepatic impairment, NUVIGIL should be administered at a reduced dose (See CLINICAL PHARMACOLOGYandPRECAUTIONS).

There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (SeeCLINICAL PHARMACOLOGYandPRECAUTIONS).

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 in this population (See CLINICAL PHARMACOLOGY andPRECAUTIONS).

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Nuvigil | Lake Erie Medical Dba Quality Care Products Llc

Obstructive Sleep Apnea (OSA) and Narcolepsy

The recommended dose of NUVIGIL for patients with OSA or narcolepsy is 150 mg or 250 mg given 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 this dose confers additional benefit beyond that of the 150 mg/day dose (See CLINICAL PHARMACOLOGY andCLINICAL TRIALS).

Shift Work Sleep Disorder (SWD)

The recommended dose of NUVIGIL for patients with SWD is 150 mg given daily approximately 1 hour prior to the start of their work shift.

Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4/5, such as steroidal contraceptives, triazolam, and cyclosporine (See PRECAUTIONS, Drug Interactions).

Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with NUVIGIL and may require dosage reduction and monitoring for toxicity (See PRECAUTIONS, Drug Interactions).

In patients with severe hepatic impairment, NUVIGIL should be administered at a reduced dose (See CLINICAL PHARMACOLOGYandPRECAUTIONS).

There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (SeeCLINICAL PHARMACOLOGYandPRECAUTIONS).

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 in this population (See CLINICAL PHARMACOLOGY andPRECAUTIONS).

No Recall
A-s Medication Solutions Llc

Nuvigil | A-s Medication Solutions Llc

Obstructive Sleep Apnea (OSA) and Narcolepsy

The recommended dose of NUVIGIL for patients with OSA or narcolepsy is 150 mg or 250 mg given 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 this dose confers additional benefit beyond that of the 150 mg/day dose (See CLINICAL PHARMACOLOGY andCLINICAL TRIALS).

Shift Work Sleep Disorder (SWD)

The recommended dose of NUVIGIL for patients with SWD is 150 mg given daily approximately 1 hour prior to the start of their work shift.

Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4/5, such as steroidal contraceptives, triazolam, and cyclosporine (See PRECAUTIONS, Drug Interactions).

Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with NUVIGIL and may require dosage reduction and monitoring for toxicity (See PRECAUTIONS, Drug Interactions).

In patients with severe hepatic impairment, NUVIGIL should be administered at a reduced dose (See CLINICAL PHARMACOLOGYandPRECAUTIONS).

There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (SeeCLINICAL PHARMACOLOGYandPRECAUTIONS).

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 in this population (See CLINICAL PHARMACOLOGY andPRECAUTIONS).

No Recall
Cephalon, Inc.

Nuvigil | Cephalon, Incorporated

2.1 Dosage 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)].
2.2 Dosage 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.
2.3 Dosage 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)].
2.4 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)].
2.1 Dosage 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)].
2.2 Dosage 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.
2.3 Dosage 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)].
2.4 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)].

No Recall