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.
|
NEWS HIGHLIGHTSMedia Articles Related to Nuvigil (Armodafinil)
CHEST: Drug Brings Wake-Up Call in Depression and OSA (CME/CE)
Source: MedPage Today Neurology [2009.11.06]
SAN DIEGO (MedPage Today) -- Armodafinil (Nuvigil) may bring relief of residual excessive sleepiness to patients with depression and obstructive sleep apnea, a multicenter, randomized trial showed.
Researcher IDs Narcolepsy as Autoimmune Disease
Source: MedicineNet Narcolepsy Specialty [2009.05.04]
Title: Researcher IDs Narcolepsy as Autoimmune Disease
Category: Health News
Created: 5/4/2009 10:38:00 AM
Last Editorial Review: 5/4/2009
Narcolepsy
Source: MedicineNet modafinil Specialty [2008.08.05]
Title: Narcolepsy
Category: Diseases and Conditions
Created: 3/4/2002
Last Editorial Review: 8/5/2008
Published Studies Related to Nuvigil (Armodafinil)
Adjunct armodafinil improves wakefulness and memory in obstructive sleep apnea/hypopnea syndrome. [2007.03]
OBJECTIVE: Armodafinil is the R-enantiomer of racemic modafinil and has a significantly longer half-life than the S-enantiomer. This study evaluated armodafinil 150mg/day as an adjunct treatment for residual excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSA/HS) who were otherwise well controlled with nasal continuous positive airway pressure (nCPAP). We assessed the ability of armodafinil to improve wakefulness and cognition and reduce fatigue in this population... CONCLUSION: Adjunct treatment with armodafinil significantly improved alertness, overall clinical condition, and long-term memory. Armodafinil also reduced fatigue and the impact of sleepiness on daily activities in patients with OSA/HS who have residual excessive sleepiness notwithstanding regular use of nCPAP. Armodafinil was well tolerated.
Pharmacokinetic profile of armodafinil in healthy subjects : pooled analysis of data from three randomized studies. [2009]
BACKGROUND AND OBJECTIVES: Armodafinil (R-modafinil) is the R- and longer-lasting isomer of the racemic compound modafinil, a wakefulness-promoting medication. Armodafinil is eliminated approximately three times more slowly than the S-isomer of racemic modafinil. Published studies have demonstrated the efficacy of armodafinil for treating excessive sleepiness associated with obstructive sleep apnoea, shift work disorder and narcolepsy. The objectives of this study were to describe the pharmacokinetic profile, tolerability and safety of armodafinil in healthy subjects... CONCLUSIONS: In the present analysis, armodafinil exhibited linear pharmacokinetics over the dose range of 50-400 mg. While food affected the rate but not the extent of absorption, peak plasma concentrations were reached in approximately 2 hours when the drug was taken on an empty stomach. With once-daily dosing, steady state appeared to be reached within 7 days. After reaching peak plasma levels, concentrations of armodafinil declined monophasically, with a mean elimination half-life of around 15 hours. Armodafinil was generally well tolerated.
Armodafinil for excessive daytime sleepiness. [2008.06]
Armodafinil is the (R)-enantiomer of the wakepromoting compound modafinil (racemic), with a considerably longer half-life of 10-15 hours. Armodafinil (developed by Cephalon, Frazer, PA, USA) was approved in June 2007 for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea syndrome and shift work disorder, and the indications are the same as those for modafinil...
Armodafinil: a new treatment for excessive sleepiness. [2008.04]
BACKGROUND: Armodafinil is a wake-promoting agent developed by Cephalon that was approved in mid-2007 for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder. It is the R-enantiomer of the compound modafinil. Like modafinil, the mechanism of action for armodafinil is not fully characterized. OBJECTIVE: To determine what data are available to support the potential use of armodafinil in clinical settings... CONCLUSION: Clinical trials demonstrated efficacy and safety profiles that were similar to those of the parent compound with wake promotion sustained throughout the day. The longer duration of effect has the potential for improved patient response and compliance but this will require further study. The primary commercial challenge may be the future availability of generic modafinil.
Armodafinil improves wakefulness and long-term episodic memory in nCPAP-adherent patients with excessive sleepiness associated with obstructive sleep apnea. [2008.03]
Residual excessive sleepiness (ES) and impaired cognition can occur despite effective and regular nasal continuous positive airway pressure (nCPAP) therapy in some patients with obstructive sleep apnea (OSA). A pooled analysis of two 12-week, randomized, double-blind studies in nCPAP-adherent patients with ES associated with OSA evaluated the effect of armodafinil on wakefulness and cognition...
Clinical Trials Related to Nuvigil (Armodafinil)
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas [Recruiting]
The purpose of this research study is to determine if armodafinil is safe and effective in
treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy
plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for
the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may
also help to reduce radiation-induced fatigue in brain tumor patients.
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.
Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS) [Not yet recruiting]
The investigation will involve a double-blind, placebo controlled, cross-over study
examining the efficacy of armodafinil in improving neurocognitive functioning and reducing
cognitive fatigue in MS. Patients who report MS-related cognitive difficulties and perform
at least 1 standard deviation below the mean on a brief cognitive screen will be given a
thorough neuropsychological evaluation at two time points. Half of the patients will be
randomized to receive a single oral dose of lactose placebo prior to the first testing
session. After a washout period of one week, they will then receive 250mg of armodafinil
prior to a second testing session (P/A group). The other half of patients will be
randomized to receive the active drug first. After a washout period of one week, they will
receive the placebo prior to a second testing session (A/P group). As plasma levels of
armodafinil peak between 2-4 hours after administration, participants will be asked to take
a single 250mg capsule 2 hours prior to the scheduled testing sessions.
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury [Recruiting]
The primary objective of the study is to determine whether armodafinil treatment is more
effective than placebo treatment in patients with excessive sleepiness associated with mild
or moderate closed traumatic brain injury (TBI).
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury [Recruiting]
The primary objective of this study is to evaluate the safety and tolerability of long-term
(12 months) armodafinil treatment in patients with excessive sleepiness associated with mild
or moderate closed traumatic brain injury (TBI).
|
