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Nuvigil

Last reviewed on RxList: 2/27/2017
Nuvigil Side Effects Center

Last reviewed on RxList 10/25/2016

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).

Tell your doctor if you have serious side effects of Nuvigil including:

  • fast/pounding/irregular heartbeat, or
  • mental/mood changes (such as agitation, confusion, depression, hallucinations, rare thoughts of suicide).

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 breastfeeding.

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.

Nuvigil Consumer Information

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)

Nuvigil Professional Information

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.

NUVIGIL has been evaluated for safety in over 1,100 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy.

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)

  NUVIGIL (%)
N=645
Placebo (%)
N=445
Headache 17 9
Nausea 7 3
Dizziness 5 2
Insomnia 5 1
Anxiety 4 1
Diarrhea 4 2
Dry Mouth 4 1
Depression 2 0
Dyspepsia 2 0
Fatigue 2 1
Palpitations 2 1
Rash 2 0
Upper Abdominal Pain 2 1
Agitation 1 0
Anorexia 1 0
Constipation 1 0
Contact Dermatitis 1 0
Decreased Appetite 1 0
Depressed Mood 1 0
Disturbance In Attention 1 0
Dyspnea 1 0
Hyperhydrosis 1 0
Increased Gamma-Glutamyltransferase 1 0
Increased Heart Rate 1 0
Influenza-Like Illness 1 0
Loose Stools 1 0
Migraine 1 0
Nervousness 1 0
Pain 1 0
Paresthesia 1 0
Polyuria 1 0
Pyrexia 1 0
Seasonal Allergy 1 0
Thirst 1 0
Tremor 1 0
Vomiting 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 (%)
N=198
NUVIGIL 150 mg (%)
N=447
NUVIGIL Combined (%)
N=645
Placebo (%)
N=445
Headache 23 14 17 9
Nausea 9 6 7 3
Insomnia 6 4 5 1
Dry Mouth 7 2 4 < 1
Rash 4 1 2 < 1
Depression 3 1 2 < 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%).

Laboratory Abnormalities

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.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of NUVIGIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders: Mouth Sores (including mouth blistering and ulceration)

Read the entire FDA prescribing information for Nuvigil (Armodafinil)

Related Resources for Nuvigil

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