Armodafinil
Encyclopedia
Armodafinil is a stimulant
-like drug produced by the pharmaceutical company
Cephalon Inc.
, which was approved by the FDA
on June 15, 2007. Armodafinil is an enantiopure
drug consisting of just the active (−)-(R)-enantiomer
of the racemic drug modafinil
(Provigil).
and shift work sleep disorder
, and as an adjunctive treatment for obstructive sleep apnea
.
Cephalon plans to conduct clinical trials evaluating the use of Nuvigil as a treatment for serious medical conditions such as bipolar depression
and fatigue in conditions such as Parkinson's disease
and cancer
. In June, 2010, it was revealed that a phase II study of Nuvigil as an adjunctive therapy in adults with schizophrenia
had failed to meet the primary endpoints, and the clinical program was subsequently ceased.
The drug was being considered for the first FDA-approved medicinally-specific drug for combating jet-lag. but on March 30, 2010, the FDA declined to approve use of Nuvigil to treat jet lag.
, nausea
, insomnia
, lack of appetite, dizziness
, agitation
, anxiety
and high blood pressure.
Stimulant
Stimulants are psychoactive drugs which induce temporary improvements in either mental or physical function or both. Examples of these kinds of effects may include enhanced alertness, wakefulness, and locomotion, among others...
-like drug produced by the pharmaceutical company
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
Cephalon Inc.
Cephalon
Cephalon, Inc. is a U.S. biopharmaceutical company co-founded in 1987 by Dr. Frank Baldino, Jr., a pharmacologist and former scientist with the DuPont Company, who served as the company's chairman and chief executive officer until his death in December 2010...
, which was approved by the FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
on June 15, 2007. Armodafinil is an enantiopure
Enantiopure drug
An enantiopure drug is a pharmaceutical that is available in one specific enantiomeric form. Most biological molecules are present in only one of many chiral forms, so different enantiomers of a chiral drug molecule bind differently to target receptors...
drug consisting of just the active (−)-(R)-enantiomer
Enantiomer
In chemistry, an enantiomer is one of two stereoisomers that are mirror images of each other that are non-superposable , much as one's left and right hands are the same except for opposite orientation. It can be clearly understood if you try to place your hands one over the other without...
of the racemic drug modafinil
Modafinil
Modafinil is an analeptic drug manufactured by Cephalon, and is approved by the U.S. Food and Drug Administration for the treatment of narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with obstructive sleep apnea...
(Provigil).
Indications
Armodafinil is approved by the FDA for the treatment of narcolepsyNarcolepsy
Narcolepsy is a chronic sleep disorder, or dyssomnia, characterized by excessive sleepiness and sleep attacks at inappropriate times, such as while at work. People with narcolepsy often experience disturbed nocturnal sleep and an abnormal daytime sleep pattern, which often is confused with insomnia...
and shift work sleep disorder
Shift work sleep disorder
Shift work sleep disorder is a circadian rhythm sleep disorder characterized by insomnia and excessive sleepiness affecting people whose work hours are scheduled during the typical sleep period...
, and as an adjunctive treatment for obstructive sleep apnea
Obstructive sleep apnea
Obstructive sleep apnea or obstructive sleep apnea syndrome is the most common type of sleep apnea and is caused by obstruction of the upper airway. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is usually associated with a reduction in...
.
Cephalon plans to conduct clinical trials evaluating the use of Nuvigil as a treatment for serious medical conditions such as bipolar depression
Bipolar disorder
Bipolar disorder or bipolar affective disorder, historically known as manic–depressive disorder, is a psychiatric diagnosis that describes a category of mood disorders defined by the presence of one or more episodes of abnormally elevated energy levels, cognition, and mood with or without one or...
and fatigue in conditions such as Parkinson's disease
Parkinson's disease
Parkinson's disease is a degenerative disorder of the central nervous system...
and cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
. In June, 2010, it was revealed that a phase II study of Nuvigil as an adjunctive therapy in adults with schizophrenia
Schizophrenia
Schizophrenia is a mental disorder characterized by a disintegration of thought processes and of emotional responsiveness. It most commonly manifests itself as auditory hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and it is accompanied by significant social...
had failed to meet the primary endpoints, and the clinical program was subsequently ceased.
The drug was being considered for the first FDA-approved medicinally-specific drug for combating jet-lag. but on March 30, 2010, the FDA declined to approve use of Nuvigil to treat jet lag.
Dosage
For narcolepsy and obstructive sleep apnea, armodafinil is taken as a once daily 150 mg or 250 mg dose in the morning. For shift work sleep disorder, 150 mg of armodafinil are taken one hour prior to starting work. Slow dose titration is needed to mitigate some side effects.Side effects
Armodafinil's common side effects include headacheHeadache
A headache or cephalalgia is pain anywhere in the region of the head or neck. It can be a symptom of a number of different conditions of the head and neck. The brain tissue itself is not sensitive to pain because it lacks pain receptors. Rather, the pain is caused by disturbance of the...
, nausea
Nausea
Nausea , is a sensation of unease and discomfort in the upper stomach with an involuntary urge to vomit. It often, but not always, precedes vomiting...
, insomnia
Insomnia
Insomnia is most often defined by an individual's report of sleeping difficulties. While the term is sometimes used in sleep literature to describe a disorder demonstrated by polysomnographic evidence of disturbed sleep, insomnia is often defined as a positive response to either of two questions:...
, lack of appetite, dizziness
Dizziness
Dizziness refers to an impairment in spatial perception and stability. The term is somewhat imprecise. It can be used to mean vertigo, presyncope, disequilibrium, or a non-specific feeling such as giddiness or foolishness....
, agitation
Agitation
Agitation may refer to:* Agitation , putting into motion by shaking or stirring* Emotional state of excitement or restlessness** Psychomotor agitation, an extreme form of the above, which can be a side effect of antipsychotic medication...
, anxiety
Anxiety
Anxiety is a psychological and physiological state characterized by somatic, emotional, cognitive, and behavioral components. The root meaning of the word anxiety is 'to vex or trouble'; in either presence or absence of psychological stress, anxiety can create feelings of fear, worry, uneasiness,...
and high blood pressure.