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Nuvigil Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Nuvigil (armodafinil) is a wakefulness-promoting agent used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder. Common side effects of Nuvigil include headache, nausea, diarrhea, upset stomach, dry mouth, anxiety, nervousness, dizziness, and difficulty sleeping (insomnia).
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.
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
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 right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood changes (such as agitation, confusion, depression, hallucinations, rare thoughts of suicide).
Get medical help right away if you have any very serious side effects, including: chest pain.
A very serious allergic reaction to this drug is rare. However, stop taking armodafinil and get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, skin blisters/peeling, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever, mouth sores, weakness, easy bruising/bleeding, symptoms of liver disease (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine).
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
The following serious adverse reactions are described below and elsewhere in the labeling:
- Serious Rash, including Stevens-Johnson Syndrome [see WARNINGS AND PRECAUTIONS]
- Angioedema and Anaphylaxis Reactions [see WARNINGS AND PRECAUTIONS]
- Multi-organ Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Persistent Sleepiness [see WARNINGS AND PRECAUTIONS]
- Psychiatric Symptoms [see WARNINGS AND PRECAUTIONS]
- Effects on Ability to Drive and Use Machinery [see WARNINGS AND PRECAUTIONS]
- Cardiovascular Events [see WARNINGS AND PRECAUTIONS]
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.
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)
|Upper Abdominal Pain||2||1|
|Disturbance In Attention||1||0|
|Increased Heart Rate||1||0|
|* Adverse reactions that occurred in ≥ 1% of NUVIGIL-treated patients and greater incidence than that of placebo.|
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 (%)
|NUVIGIL 150 mg (%)
|NUVIGIL Combined (%)
|Dry Mouth||7||2||4||< 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%).
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 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.
Read the entire FDA prescribing information for Nuvigil (Armodafinil)
Additional Nuvigil Information
Nuvigil - User Reviews
Nuvigil User Reviews
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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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