Nuvigil

Armodafinil comes as a tablet to take by mouth. It is usually taken once a day. If you are taking armodafinil to treat narcolepsy or OSAHS, you will probably take it in the morning. If you are taking armodafinil to treat shift work sleep disorder, you will probably take it 1 hour before the start of your shift. Take armodafinil at around the same time every day. Do not change the time of day that you take armodafinil without talking to your doctor. Talk to your doctor if your work shift does not begin at the same time every day. Follow the directions on your prescription label carefully, and ask our doctor or pharmacist to explain any part you do not understand. Take armodafinil exactly as directed.

Armodafinil may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Armodafinil may decrease your sleepiness, but it will not cure your sleep disorder. Continue to take armodafinil even if you feel well-rested. Do not stop taking armodafinil without talking to your doctor.

Armodafinil should not be used in place of getting enough sleep. Follow your doctor's advice about good sleep habits. Continue to use any breathing devices or other treatments that your doctor has prescribed to treat your condition, especially if you have OSAHS.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Armodafinil can decrease or increase the activity of enzymes in the liver that metabolize (eliminate) other drugs. This can result in decreased levels of some drugs that reduce their effectiveness as well as increased levels of other drugs that increase their toxicity. Armodafinil treatment should be carefully monitored if taken with any of these drugs.

Drugs which may have reduced effectiveness if taken with armodafinil include cyclosporine (Sandimmune), ethinyl estradiol (Estrace, Climara, Estraderm, Menostar) (present in many birth control pills), midazolam (Versed), and triazolam (Halcion).

Drugs that may show increased effects or toxicity if taken with armodafinil include omeprazole (Prilosec), warfarin (Coumadin), diazepam (Valium), propranolol (Inderal), imipramine (Tofranil), desipramine (Norpramin), clomipramine (Anafranil), phenytoin (Dilantin) and mephenytoin (Mesantoin).

Carbamazepine (Tegretol), phenobarbital, and rifampin (Rifadin) may reduce the action of armodafinil by increasing armodafinil's elimination by the liver. Ketoconazole (Nizoral), itraconazole (Sporanox) and erythromycin may increase the effectiveness of armodafinil by reducing the elimination of armodafinil by the liver.

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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nuvigil, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nuvigil falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Hormonal birth control methods may not work while you take Nuvigil. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking Nuvigil, and for one month after stopping Nuvigil. Talk to your doctor about birth control choices that are right for you while taking Nuvigil.

• Store Nuvigil at 20° to 25°C (68° to 77°F).
• Keep this and all medicines out of the reach of children.
• Nuvigil is classified as federally controlled substance (C-IV), because it can be abused or lead to dependence. Keep Nuvigil in a safe place to prevent misuse and abuse.

Contraindications

• Known hypersensitivity to armodafinil, modafinil, or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Serious rash (e.g., Stevens-Johnson syndrome [SJS]) requiring hospitalization and drug discontinuance reported in adults receiving armodafinil and in adults and pediatric patients receiving modafinil.1 30

Serious or life-threatening rash (e.g., SJS, toxic epidermal necrolysis [TEN]) and drug rash with eosinophilia and systemic symptoms (DRESS) reported rarely in adults and pediatric patients during postmarketing experience with modafinil.1 30 Severe rash (e.g., possible SJS, multiorgan hypersensitivity reaction), sometimes associated with fever and other abnormalities (e.g., vomiting, leukopenia), also observed in pediatric clinical trials of modafinil.1 30 A similar risk of serious rash in pediatric patients receiving armodafinil cannot be excluded.1 Armodafinil is not approved for use in pediatric patients for any indication.1 (See Pediatric Use under Cautions.)

No known risk factors predict the occurrence or severity of rash.1 30 Nearly all cases occurred within 1–5 weeks following initiation of modafinil or armodafinil therapy, but cases also reported after prolonged (e.g., 3 months) treatment.1 30

Benign rashes also occur with armodafinil; not possible to predict which rashes will become serious.1 Therefore, discontinue drug at first sign of rash unless clearly not drug related.1 (See Advice to Patients.) Rash may become potentially life-threatening or permanently disabling or disfiguring despite drug discontinuance.1

In patients with abnormal levels of sleepiness, level of wakefulness may improve with armodafinil therapy, but may not return to normal.1 (See Advice to Patients.)

Frequently reassess degree of sleepiness, and, if appropriate, advise patients to avoid driving or other potentially dangerous activity.1 Patients may not acknowledge sleepiness or drowsiness until directly questioned about these symptoms during specific activities.1 (See Advice to Patients.)

Adverse psychiatric effects (e.g., mania, delusions, hallucinations, suicidal ideation, aggression), sometimes resulting in hospitalization, reported in modafinil-treated patients;1 7 32 many, but not all, such patients had a psychiatric history.1 7 Incidence and type of psychiatric effects expected to be similar with armodafinil.1 7 32

In controlled clinical trials, psychiatric symptoms requiring treatment discontinuance more often for armodafinil than for placebo include anxiety, agitation, nervousness, irritability, and depression; suicidal ideation also reported.1

Use with caution in patients with a history of psychosis, depression, or mania.1

Some clinicians recommend careful monitoring of patients receiving armodafinil or other CNS stimulants for possible psychiatric effects.32 If psychiatric symptoms develop, consider drug discontinuance.1 (See Advice to Patients.)

Sensitivity Reactions

Angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm) reported.1

Immediately discontinue therapy if any signs or symptoms of angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty swallowing or breathing; hoarseness) develop.1

Multiorgan hypersensitivity reactions, including at least 1 fatality, reported with modafinil.1 Similar risk with armodafinil cannot be ruled out.1

Reactions detected a median of 13 days (range: 4–33 days) after initiation of modafinil.1 Clinical presentation is variable but typically included fever and rash associated with other organ system involvement (e.g., myocarditis, hepatitis, liver function test abnormalities, hematological abnormalities [e.g., eosinophilia, leukopenia, thrombocytopenia], pruritus, asthenia).1

No risk factors known to predict occurrence or severity.1

If a multiorgan hypersensitivity reaction is suspected, discontinue therapy.1 Cross-sensitivity with other drugs that produce this syndrome not yet reported but is possible.1

General Precautions

Use only in patients who have had a complete evaluation (e.g., complete history, physical examination, testing in a laboratory setting [polysomnography]) of excessive sleepiness and in whom a diagnosis of narcolepsy, OSAHS, and/or SWSD has been made in accordance with International Classification of Sleep Disorders (ICSD) or DSM diagnostic criteria.1

Consider that >1 sleep disorder may contribute to daytime sleepiness in some patients (e.g., OSAHS and SWSD concurrently in the same patient).1

In OSAHS, armodafinil is indicated as an adjunct to standard treatment(s) for the underlying obstruction.1 If CPAP is the treatment of choice, make a maximal effort to treat with CPAP for an adequate period of time prior to initiating armodafinil therapy.1 If armodafinil is used adjunctively with CPAP, necessary to encourage and periodically assess CPAP compliance.1 (See Advice to Patients.)

Although armodafinil has not been shown to cause functional impairment, altered judgment, thinking, or motor skills is possible with any drug affecting the CNS.1 (See Advice to Patients.)

Armodafinil is subject to control as a schedule IV (C-IV) drug.1 18 Abuse potential not specifically studied, but expected to be similar to that of modafinil.1 18

Produces psychoactive and euphoric effects and alterations in mood, perception, thinking, and feelings similar to those observed with other CNS stimulants (e.g., amphetamines, methylphenidate), but current evidence indicates risk of abuse or misuse is lower with armodafinil and modafinil than with schedule II CNS stimulants (e.g., amphetamine, methylphenidate).1 7 8 17 18 25 (See Actions.)

Monitor patients closely during treatment for possible signs of misuse or abuse (e.g., incrementation of doses, drug-seeking behavior), particularly in those with a history of drug or stimulant abuse (e.g., amphetamine, cocaine, methylphenidate).1 7

Adverse cardiovascular effects (e.g., chest pain, palpitations, dyspnea, transient ischemic T-wave changes on ECG) reported with modafinil; similar risk expected with armodafinil.1

Not recommended in patients with history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome (e.g., ischemic ECG changes, chest pain, arrhythmia) with CNS stimulant use.1 If new onset of any of these symptoms of mitral valve prolapse syndrome occurs during armodafinil therapy, consider cardiac evaluation.1

Use with caution in patients with recent history of MI or unstable angina.1

Increased monitoring of BP may be appropriate during therapy.1

Possible reduced efficacy of hormonal contraceptives during and for 1 month after discontinuance of therapy.1 7 Alternative or concomitant contraceptive methods recommended during these periods.1 7 (See Specific Drugs under Interactions and see Advice to Patients.)

Possible reduced cyclosporine blood concentrations when given concurrently with armodafinil.1 (See Specific Drugs under Interactions.)

Specific Populations

Category C.1

Not known whether armodafinil or its metabolites are distributed into milk.1 Caution if used in nursing women.1

Armodafinil is not approved for use in pediatric patients for any indication.1 Safety and efficacy not established in children <17 years of age.1

Serious rashes (e.g., erythema multiforme, Stevens-Johnson syndrome) associated with use of modafinil in pediatric patients.1 30 (See Serious Dermatologic Reactions under Cautions.)

Safety and efficacy not established in patients >65 years of age.1

Elimination of armodafinil and its metabolites may be reduced; consider reduced dosage.1 7 (See Geriatric Patients under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Armodafinil not specifically studied in patients with hepatic impairment.1 However, possible reduced clearance in patients with severe hepatic impairment based on pharmacokinetic studies with modafinil.1 Reduce dosage in patients with severe hepatic impairment, with or without cirrhosis.1 7 (See Hepatic Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Inadequate information to determine safety and efficacy in patients with severe renal impairment.1 (See Renal Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Common Adverse Effects

Headache, nausea, dizziness, insomnia.1 2 3 4 5 7 10 12 13 19

• Importance of reading patient information leaflet provided by the manufacturer prior to initiating therapy.1

• Importance of advising clinician of existing or contemplated therapy, including prescription and OTC drugs and/or herbal supplements, as well as any concomitant illnesses.1 Advise patient that it is prudent to avoid alcohol since combined use has not been studied.1

• Potential increased risk of pregnancy in women taking hormonal contraceptives (including oral contraceptives, injectable or implantable contraceptives, transdermal systems, vaginal rings, and intrauterine devices) during and for 1 month after discontinuing armodafinil therapy; discuss use of alternative or concomitant methods of contraception during these periods.1 (See Contraceptive Precautions under Cautions.) Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Risk of serious rash or serious allergic reaction.1 Advise patient to immediately discontinue armodafinil and notify their clinician if they develop a rash or other manifestations of an allergic reaction (e.g., hives, mouth sores, blisters, peeling skin, difficulty swallowing or breathing, related allergic phenomenon).1

• Risk of mental (psychiatric) symptoms.1 Importance of discontinuing armodafinil and informing clinician if depression, anxiety, hallucinations, mania, suicidal thoughts, aggression, or other psychiatric symptoms associated with psychosis or mania occur.1

• Risk of heart problems.1 Importance of discontinuing armodafinil and informing clinician if heart problems, including chest pain, occur.1

• Advise that armodafinil may affect judgment, thinking, or motor skills.1 Use caution when operating machinery or driving a motor vehicle until effects of the drug are known.1

• Advise patient that armodafinil may improve, but not eliminate, the abnormal tendency to fall asleep.1 Therefore, stress importance of not altering previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness until and unless armodafinil produces sufficient wakefulness that permits such activities.1 Advise that armodafinil therapy is not a replacement for sleep.1

• Importance of continuing previously prescribed therapy (e.g., patients with OSAHS should continue using their CPAP machine while sleeping).1

• Importance of advising patients of other important precautionary information.1 (See Cautions.)

• If you have an allergy to armodafinil, modafinil, or any other part of Nuvigil (armodafinil).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have ever had a rash when taking this medicine or a drug like it.
• If you have heart problems.
• If you have heart valve problems.

This is not a list of all drugs or health problems that interact with Nuvigil.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Headache.
• Loose stools (diarrhea).
• Not able to sleep.
• Back pain.
• Dizziness.
• Upset stomach.
• Dry mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Nuvigil, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nuvigil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Nuvigil.

Review Date: October 4, 2017

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)].

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.

Taking Nuvigil with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with armodafinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

You should not use this medicine if you are allergic to armodafinil or modafinil (Provigil).

To make sure armodafinil is safe for you, tell your doctor if you have:

• liver or kidney disease;

• a heart muscle or valve disorder such as mitral valve prolapse;

• high blood pressure, heart disease, or prior heart attack;

• a history of mental illness or psychosis; or

• a history of drug or alcohol addiction.

It is not known whether armodafinil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether armodafinil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Armodafinil is not approved for use by anyone younger than 17 years old.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Armodafinil may be habit-forming. Never share armodafinil with another person, especially someone with a history of drug abuse or addiction. Selling or giving away armodafinil is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Armodafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.

You may take armodafinil with or without food.

Armodafinil is usually given for up to 12 weeks. Follow your doctor's instructions.

If you are taking armodafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.

Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and armodafinil may be necessary to best treat your condition.

Taking this medication does not take the place of getting enough sleep. Talk with your doctor if you continue to have excessive sleepiness even while taking armodafinil. Armodafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Armodafinil is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.