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Nuvigil

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Nuvigil

Nuvigil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nuvigil (armodafinil) is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder. It is a wakefulness-promoting agent. Common side effects include headache, nausea, dry mouth, anxiety, dizziness, and difficulty sleeping.

The recommended dose of Nuvigil for patients with sleep apnea or narcolepsy is 150 mg or 250 mg given as a single dose in the morning. The recommended dose of Nuvigil for patients with shift work disorder is 150 mg given daily approximately 1 hour prior to the start of their work shift. Nuvigil may interact with cyclosporine, propranolol, omeprazole, rifampin, sedatives, seizure medications, antidepressants, or antibiotics. Tell your doctor all medications you use. Nuvigil should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Nuvigil (armodafinil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nuvigil in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using armodafinil and call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
  • the first sign of any type of skin rash, no matter how mild;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • easy bruising or bleeding;
  • mouth sores, trouble swallowing;
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • depression, confusion, hallucinations, aggression, unusual thoughts or behavior;
  • chest pain, uneven heart beats.

Less serious side effects may include:

  • headache, dizziness;
  • feeling nervous or anxious;
  • nausea, diarrhea, upset stomach;
  • trouble sleeping (insomnia); or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nuvigil (Armodafinil) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Nuvigil Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, nausea, dry mouth, anxiety, dizziness, and difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., agitation, confusion, depression, hallucinations, rare thoughts of suicide), unusual tiredness, dark urine, yellowing eyes/skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe abdominal pain, chest pain, fast/pounding/irregular heartbeat.

Rarely, this medication may cause a serious (rarely fatal) rash. You may not be able to tell this serious reaction apart from a minor rash. Therefore, stop taking this drug and seek immediate medical attention if you develop any rash.

A very serious allergic reaction to this drug is rare. However, stop taking armodafinil and seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/hives, skin blisters/peeling, sores in the mouth, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing/swallowing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Nuvigil (Armodafinil)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nuvigil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

“The following serious adverse reactions are described below and elsewhere in the labeling:

Clinical 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.

OSA, SWD, and Narcolepsy

NUVIGIL has been evaluated for safety in over 1100 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy.

In the pre-approval controlled clinical trials, 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 pre-approval 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 1) 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 pre-approval 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 1: Incidence 1% or Greater Of Treatment-Emergent Adverse Experiences In Parallel-Group, Placebo-Controlled Clinical Trials* In OSA, Narcolepsy and SWD With NUVIGIL (150 mg and 250 mg)

System Organ Class MedDRA preferred term NUVIGIL
(%)
N=645
Placebo
(%)
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
* 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 pre-approval 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. See Table 2 for additional information.

Table 2: Incidence Of Dose-Dependent, Treatment-Emergent Adverse Experiences By Dose and By Treatment In Parallel-Group, Placebo-Controlled Clinical Trials* In OSA, Narcolepsy and SWD With NUVIGIL (150 mg and 250 mg)

System Organ Class MedDRA preferred term NUVIGIL 250 mg
(%)
N=198
NUVIGIL 150 mg
(%)
N=447
NUVIGIL Combined
(%)
N=645
Placebo
(%)
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
* Four double-blind, placebo-controlled clinical studies in SWD, OSA, and narcolepsy.

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 (ALT), aspartate aminotransferase (AST), 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.

Vital Sign Changes

Blood pressure monitoring in pre-approval controlled trials of OSA, SWD, and narcolepsy showed small average increases in mean systolic and diastolic blood pressure in patients receiving NUVIGIL as compared to placebo (1.2 to 4.3 mmHg in the various experimental groups). There was also a slightly greater proportion of patients on NUVIGIL requiring new or increased use of antihypertensive medications (2.9%) compared to patients on placebo (1.8%). There was a small, but consistent, average increase in pulse rate over placebo in pre-approval controlled trials. This increase varied from 0.9 to 3.5 BPM. [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Nuvigil (Armodafinil) »

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Nuvigil - User Reviews

Nuvigil User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Nuvigil sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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