BOX WARNING
NUVIGIL is a 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. Selling or giving away NUVIGIL may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
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NUVIGIL SUMMARY
NUVIGIL™ (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a mixture of the R- and S-enantiomers.
NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy and shift work sleep disorder.
In OSAHS, 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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NEWS HIGHLIGHTSMedia Articles Related to Nuvigil (Armodafinil)
Narcolepsy
Source: MedicineNet modafinil Specialty [2010.08.10]
Title: Narcolepsy
Category: Diseases and Conditions
Created: 3/4/2002 12:00:00 AM
Last Editorial Review: 8/10/2010 12:00:00 AM
Published Studies Related to Nuvigil (Armodafinil)
Armodafinil and modafinil in patients with excessive sleepiness associated with
shift work disorder: a pharmacokinetic/pharmacodynamic model for predicting and
comparing their concentration-effect relationships. [2012]
Armodafinil, the longer lasting R-isomer of racemic modafinil, improves
wakefulness in patients with excessive sleepiness associated with shift work
disorder (SWD). Pharmacokinetic studies suggest that armodafinil achieves higher
plasma concentrations than modafinil late in a dose interval following equal oral
doses...
The effect of adjunctive armodafinil on cognitive performance and psychopathology in antipsychotic-treated patients with schizophrenia/schizoaffective disorder: a randomized, double-blind, placebo-controlled trial. [2011.08]
CONCLUSIONS: There were no significant differences in neurocognitive measures between adjunctive armodafinil and placebo in this 6-week study. Armodafinil improved anhedonia-asociality, but not other negative symptom domains. Copyright (c) 2011 Elsevier B.V. All rights reserved.
Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial. [2011.07]
CONCLUSIONS: As we found in our RCT of modafinil, armodafinil appears effective and well tolerated in treating fatigue in HIV+ patients. Side effects were minimal and most patients reported substantially improved energy and mood. Copyright (c) 2011 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.
Modafinil and armodafinil treatment for fatigue for HIV-positive patients with and without chronic hepatitis C. [2011.02]
Fatigue is prevalent among patients with hepatitis C virus (HCV) and with HIV/AIDS but there are no established fatigue treatments for either condition or their combination. We analysed data from three trials of modafinil or armodafinil for HIV-positive patients with fatigue, including 36 co-infected with HCV, to compare treatment response and safety parameters related to HCV status...
Treatment of HIV-related fatigue with armodafinil: a placebo-controlled
randomized trial. [2011]
CONCLUSIONS: As we found in our RCT of modafinil, armodafinil appears effective
Clinical Trials Related to Nuvigil (Armodafinil)
Nuvigil or Placebo in Newly Diagnosed Malignant Glioma [Recruiting]
The purpose of this study is to determine if Nuvigil® improves fatigue experienced by people
receiving external beam radiation therapy for the treatment of malignant gliomas. It is also
being done to determine if Nuvigil® improves cognitive function (perception, thinking,
reasoning, and remembering) and overall quality of life in people receiving external beam
radiation therapy for the treatment of malignant gliomas. Another purpose of this study is
to see if people who receive Nuvigil® have more or less side effects than people who receive
placebo. Placebo is a substance that looks like an active drug but has no active ingredient.
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS [Recruiting]
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is
effective in reducing fatigue in adults with HIV/AIDS.
Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients [Recruiting]
The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to
control fatigue in patients with CML. The safety of this drug will also be studied.
Single Agent Armodafinil for Patient-Reported Fatigue [Recruiting]
A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder [Recruiting]
The primary objective of the study is to determine whether armodafinil treatment, at a
dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood
stabilizers for treatment of adults with major depression associated with bipolar I
disorder.
Reports of Suspected Nuvigil (Armodafinil) Side Effects
Drug Ineffective (164),
Headache (105),
Insomnia (93),
Nausea (67),
Rash (54),
OFF Label USE (53),
Feeling Abnormal (47),
Anxiety (45),
Somnolence (41),
Dizziness (40), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Nuvigil has an overall score of 8.67. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Nuvigil review by 50 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | originally sleep apnea |
| Dosage & duration: | | 150mg taken 1 a day for the period of a year and still taking it |
| Other conditions: | | at the begining , secondary polycythemia |
| Other drugs taken: | | linsinapril (for blood pressure) and 80mg baby asprin, and celebrex for joints, and teststostirone s | | |
Reported Results |
| Benefits: | | Benefits were I was able to stay awake during the day. And now that I have esophageal cancer I strongly believe Nuvigil is a big help with the side effects of chemoradiation treatments. |
| Side effects: | | I haven't seen any side effects yet. |
| Comments: | | I have since been dianosed with esophageal cancer, I am in a 5 week treatment regimine with chemo and radiation and then i'll be going through surgery. I asked and was told it would be ok to keep taking the Nuvigil during all this and I am really happy that I am able to keep taking it. I really think it is helping me with some of the side effects from the chemoradiation treatments i have been getting. I'm right in the center of treatments now and I am suppose to have the lowest blood cell count now but I don't think so. I see the doctor today and get my first cbc done since I started. I think the Nuvigil is a big help while going through this and I think the doctors are seeing that too. I've been going to work everyday while getting all my treatments. And I'm sure that would not be happing without the Nuvigil. |
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| | Nuvigil review by 34 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Shift work sleep disorder |
| Dosage & duration: | | 250mg taken daily for the period of 3mo |
| Other conditions: | | none |
| Other drugs taken: | | Minocycline, clindamycin cream, benzoyl peroxide. | | |
Reported Results |
| Benefits: | | Extremely effective for staying awake. No jitters, just plain awake. Puts you in a great mood too, but definitely not high. |
| Side effects: | | ACNE. Horrible acne that starts deep in the skin and comes in clusters. I never had acne before this. I stopped this drug a few times, and the acne cleared up immediately. I have to find something to clear this up, or I will have to stop taking it for good. I started acne drugs listed above with no effect. This is terrible, Nuvigil works so good, but my skin looks dreadful. Clusters of gross looking acne, each is a big bump of different sizes. |
| Comments: | | Works great, but acne is terrible |
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| | Nuvigil review by 34 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Shift work sleep disorder |
| Dosage & duration: | | 250mg taken daily for the period of 3mo |
| Other conditions: | | none |
| Other drugs taken: | | Minocycline, clindamycin cream, benzoyl peroxide. | | |
Reported Results |
| Benefits: | | Extremely effective for staying awake. No jitters, just plain awake. Puts you in a great mood too, but definitely not high. |
| Side effects: | | ACNE. Horrible acne that starts deep in the skin and comes in clusters. I never had acne before this. I stopped this drug a few times, and the acne cleared up immediately. I have to find something to clear this up, or I will have to stop taking it for good. I started acne drugs listed above with no effect. This is terrible, Nuvigil works so good, but my skin looks dreadful. Clusters of gross looking acne, each is a big bump of different sizes. |
| Comments: | | Works great, but acne is terrible |
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Page last updated: 2013-02-10
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