This information is not for clinical use. These highlights do not include all the information needed to use Nuvigil safely and effectively. Before taking Nuvigil please consult with your doctor. See full prescribing information for Nuvigil.

Indications And Usage

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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Contraindications

NUVIGIL is contraindicated in patients with known hypersensitivity to modafinil and armodafinil or its inactive ingredients.

Adverse Reactions

Armodafinil has been evaluated for safety in over 1100 patients with excessive sleepiness associated with primary disorders of sleep and wakefulness. In clinical trials, NUVIGIL has been found to be generally well tolerated and most adverse experiences were mild to moderate. In the placebo-controlled clinical studies, the most commonly observed adverse events (≥ 5%) associated with the use of NUVIGIL occurring more frequently than in the placebo-treated patients were headache, nausea, dizziness, and insomnia. The adverse event profile was similar across the studies. In the placebo-controlled clinical trials, 44 of the 645 patients (7%) who received NUVIGIL discontinued due to an adverse experience compared to 16 of the 445 (4%) of patients that received placebo. The most frequent reason for discontinuation was headache (1%). Incidence in Controlled Trials The following table (Table 3) presents the adverse experiences that occurred at a rate of 1% or more and were more frequent in patients treated with NUVIGIL than in placebo group patients in the placebo-controlled clinical trials. The prescriber should be aware that the figures provided below cannot be used to predict the frequency of adverse experiences in the course of usual medical practice, where patient characteristics and other factors may differ from those occurring during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. Review of these frequencies, however, provides prescribers with a basis to estimate the relative contribution of drug and non-drug factors to the incidence of adverse events in the population studied. Table 3. Incidence > 1% (In Percent) Of Treatment-Emergent Adverse Experiences In Parallel-Group, Placebo-Controlled Clinical Trialsª In OSA, Narcolepsy and SWD With NUVIGIL (150 mg and 250 mg) System Organ Class MedDRA preferred term NUVIGIL (Percent, N=645) Placebo (Percent, N=445) Cardiac Disorders Palpitations 2 1 Gastrointestinal Disorders Nausea 7 3 Diarrhea 4 2 Dry Mouth 4 1 Dyspepsia 2 0 Abdominal Pain Upper 2 1 Constipation 1 0 Vomiting 1 0 Loose Stools 1 0 General Disorders And Administration Site Conditions Fatigue 2 1 Thirst 1 0 Influenza-Like Illness 1 0 Pain 1 0 Pyrexia 1 0 Immune System Disorders Seasonal Allergy 1 0 Investigations Gamma-Glutamyltransferase Increased 1 0 Heart Rate Increased 1 0 Metabolism And Nutrition Disorders Anorexia 1 0 Decreased Appetite 1 0 Nervous System Disorders Headache 17 9 Dizziness 5 2 Disturbance In Attention 1 0 Tremor 1 0 Migraine 1 0 Paresthesia 1 0 Psychiatric Disorders Insomnia 5 1 Anxiety 4 1 Depression 2 0 Agitation 1 0 Nervousness 1 0 Depressed Mood 1 0 Renal And Urinary Disorders Polyuria 1 0 Respiratory, Thoracic And Mediastinal Disorders Dyspnea 1 0 Skin And Subcutaneous Tissue Disorders Rash 2 0 Contact Dermatitis 1 0 Hyperhydrosis 1 0 ª Four double-blind, placebo-controlled clinical studies in SWD, OSA, and narcolepsy; incidence is rounded to the nearest whole percent. Included are only those events for which NUVIGIL incidence is greater than that of placebo. Dose Dependency of Adverse Events In the placebo-controlled clinical trials which compared doses of 150 mg/day and 250 mg/day of NUVIGIL and placebo, the only adverse events that appeared to be dose-related were headache, rash, depression, dry mouth, insomnia, and nausea. Table 4. Incidence (In Percent) Of Dose-Dependent , Treatment-Emergent Adverse Experiences By Dose and By Treatment In Parallel-Group, Placebo-Controlled Clinical Trialsa In OSA, Narcolepsy and SWD With NUVIGIL (150 mg and 250 mg) System Organ Class MedDRA preferred term NUVIGIL 250 mg (Percent, N=198) NUVIGIL 150 mg (Percent, N=447) NUVIGIL Combined (Percent, N=645) Placebo (Percent, N=445) Gastrointestinal Disorders Nausea 9 6 7 3 Dry Mouth 7 2 4 <1 Nervous System Disorders Headache 23 14 17 9 Psychiatric Disorders Insomnia 6 4 5 1 Depression 3 1 2 <1 Skin And Subcutaneous Tissue Disorders Rash 4 1 2 <1 ª Four double-blind, placebo-controlled clinical studies in SWD, OSA, and narcolepsy. Vital Sign Changes There were small, but consistent, increases in average values for mean systolic and diastolic blood pressure in controlled trials (See PRECAUTIONS ). There was a small, but consistent, average increase in pulse rate over placebo in controlled trials. This increase varied from 0.9 to 3.5 BPM. Laboratory Changes 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 subjects, however, had GGT or AP elevations outside of the normal range. No differences were apparent in alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total bilirubin, although there were rare cases of isolated elevations of AST and/or ALT. A single case of mild pancytopenia was observed after 35-days of treatment and resolved with drug discontinuation. A small mean decrease from baseline in serum uric acid compared to placebo was seen in clinical trials. The clinical significance of this finding is unknown. ECG Changes No pattern of ECG abnormalities could be attributed to NUVIGIL administration in placebo-controlled clinical trials.

Drug Interactions

Drug-Drug Interactions The existence of multiple pathways for armodafinil metabolism, as well as the fact that a non-CYP-related pathway is the most rapid in metabolizing armodafinil, suggest that there is a low probability of substantive effects on the overall pharmacokinetic profile of NUVIGIL due to CYP inhibition by concomitant medications. In vitro data demonstrated that armodafinil shows a weak inductive response for CYP1A2 and possibly CYP3A activities in a concentration-related manner and that CYP2C19 activity is reversibly inhibited by armodafinil. Other CYP activities did not appear to be affected by armodafinil. An in vitro study demonstrated that armodafinil is a substrate of P-glycoprotein. Chronic administration of NUVIGIL at 250 mg reduced the systemic exposure to midazolam by 32% and 17% after single oral (5 mg) and intravenous (2 mg) doses, respectively, suggesting that administration of NUVIGIL moderately induces CYP3A activity. Drugs that are substrates for CYP3A4/5, such as cyclosporine, may require dosage adjustment. (See PRECAUTIONS, Drug Interactions ). Chronic administration of NUVIGIL at 250 mg did not affect the pharmacokinetics of caffeine (200 mg), a probe substrate for CYP1A2 activity. Coadministration of a single 400-mg dose of NUVIGIL with omeprazole (40 mg) increased systemic exposure to omeprazole by approximately 40%, indicating that armodafinil moderately inhibits CYP2C19 activity. Drugs that are substrates for CYP2C19 may require dosage reduction. (See PRECAUTIONS, Drug Interactions ).