Inthe FDA approved modafinil for the first time, for narcolepsy patients, and inexpanded the uses for which it could be marketed to patients with daytime sleepiness resulting from obstructive sleep apnea or shift-work sleep disorder. Physicians are expected to use their judgment and scientific knowledge gleaned from people other than drug-company Prlvigil to recommend certain drugs to their patients who do not fit the FDA profiles.
But even a company that gets caught breaking that law may, in the end, benefit. Those alleged prohibited promotions may have helped spur the fifteen-fold growth of modafinil prescriptions for off-label uses seen by Omachi and his team.
In the same period, prescriptions for patients with diagnoses of narcolepsy, shift-work sleep disorder and sleep apnea grew only threefold. For some of those taking modafinil off-label, Omachi warns that safety could be a concern. The clinical trials that led Provigjl FDA to approve modafinil specifically excluded potential subjects who were taking antidepressants. If some of the fastest growth in modefinil use is among those with depression, then potentially harmful drug interactions are likely, and should prompt FDA Provigil Off Label Use, the researchers suggested.
She covers prescription drugs, obesity, nutrition and exercise, and neuroscience, mental health and Provigil Off Label Use behavior.
As a baby boomer, she keenly follows trends in midlife weight gain, memory loss and the health benefits of red wine. More From the Los Angeles Times. All Sections. About Us. B2B Publishing. The number of patients receiving modafinil for on-label vs off-label use.
Off-label uses of modafinil
Limit lines indicate standard error. Trends in on-label and off-label modafinil use in a nationally representative sample. Published online March 18, Modafinil is a nonamphetamine stimulant Ogf for narcolepsy, obstructive sleep apnea, and shift-work sleep disorder. Using the National Ambulatory Medical Care Survey, a nationally representative sample of ambulatory visits, we examined modafinil use from January 1,through December 31, Finally, we examined the association between modafinil use and other centrally acting medications that might interact with modafinil: antidepressants, benzodiazepines, and amphetamines.
One of the most prescribed off-label uses of Provigil is for attention-deficit disorder (ADD) and attention-deficit hyperactivity disorder (ADHD). Users have said that the drug helps them maintain concentration and a highly focused state, as well as improving attention and memory. There have been many double-blind. Modafinil, sold under the brand name Provigil among others, is a medication to treat sleepiness due to narcolepsy, shift work sleep disorder, or obstructive sleep apnea.
In multivariate logistic regression, modafinil use was the outcome, and the predictor variables of interest were, in separate models, diagnostic Provigul, physician specialty, and concurrent medication. A supplemental description of our methods is available online eMethods.
The number of patients receiving modafinil increased almost fold during the study period, from 57 in to in On-label use increased by less than 3-fold, whereas off-label use increased more than fold Figure.
Provigil: Side effects, dosage, uses, and more
Provvigil analyses demonstrated an association between modafinil use and each examined potential off-label indication: multiple sclerosis, odds ratio [OR], Patients treated by psychiatrists OR, Each examined medication class was associated with increased odds of concurrently receiving modafinil: antidepressants OR, 8. These analyses indicate the rapid recent increase in modafinil use and suggest that most prescriptions are for off-label indications.
That modafinil appears strongly associated with depression and multiple sclerosis is especially noteworthy given that the trials Provigil Off Label Use which the US Food and Drug Administration Peovigil modafinil excluded patients with such diseases. To place temporal trends into context, certain events related to modafinil's marketing and adverse event reporting should be noted.
Cephalon, Inc, which markets modafinil, was sued by multiple US states for promoting modafinil for off-label indications and agreed to a multimillion dollar settlement in Nonetheless, substantial increases in modafinil use occurred between andafter this case was settled.
Of note, modafinil use declined substantially between and This may have been the result of reports released during that time of modafinil-associated hypersensitivity reactions. Our study has important limitations. Data about the specific diagnosis for which modafinil was prescribed were not Proviigil. In addition, only the top 3 diagnoses per encounter were listed, and we cannot exclude the possibility that an on-label indication may have existed.
Nonetheless, the results strongly suggest that off-label indications are responsible for a large share of prescriptions given that patients receiving modafinil without an on-label diagnosis increased by fold while those with an on-label diagnosis increased by only 3-fold. Also, off-label indications for which modafinil has commonly been recommended are strongly associated with its use.
"Off-label" use of anti-drowsiness drug skyrockets
Finally, patients are much more likely to be receiving modafinil if they are being seen by a psychiatrist or neurologist—specialists who treat off-label indications, such as depression, multiple sclerosis, and Parkinson disease. Modafinil use is increasing rapidly, which appears in large part to result from off-label prescribing.
Given that modafinil is often being used in patients with comorbid conditions and concurrent medications that do not reflect the populations that formed the basis for regulatory approval, this raises concerns about the potential for adverse events and indicates the need for further study of unapproved indications. Published Online: March 18, Critical revision of the manuscript for important intellectual content : Sarkar, Claman, and Omachi.
Supplemental methods eReferences. Diagnoses associated with receiving modafinil eTable 2. Physician specialty associated with receiving modafinil. Ballon JS, Feifel D.
Provigil is used off-label. buymodafinilntx.com › articles.