Off-label Use of Modafinil
While Modafinil is FDA-approved for narcolepsy, obstructive sleep apnea hypopnea syndrome and shift-word sleep disorder, many physicians prescribe it for patients who do not suffer from one of these conditions but exhibit similar symptoms. An off-label use is one that was not studied as a part of the FDA approval process. The FDA controls marketing of drugs in the United States and they prohibit advertising drugs for uses the FDA has not explicitly approved them for.
Manufacturers are allowed to advertise drugs for what they are labeled for. They have indirect ways of promoting off-label use, including sponsoring papers by doctors who advocate expanded use. Off-label uses often come from the community of practice – doctors and nurse practitioners – who figure it out in dealing with patients. Cephalon, the company that made modafinil years ago, was sued by several US states for promoting off-label use. The case was settled out of court.
Modafinil is being prescribed to patients for "off-label" or “lifestyle” uses, including:
- Age-related memory decline
- Attention deficit disorder
- Fatigue caused by high-pressure jobs requiring long hours
- Fatigue caused by chemotherapy treatment for cancer patients
- Fatigue experienced by persons suffering from diseases such as multiple sclerosis
- Fatigue experienced by people who need to be awake and alert for extended amounts of times such as soldiers, truckers or students cramming for exams
- Jet lag
- Memory problems associated with Alzheimer's disease
- Parkinson's Disease patients
- Post-anesthesia grogginess
- Sleepiness caused by other prescription medications
- Treatment for cocaine addiction
Some people take it for fun or to get a competitive edge in the workplace. There have been no long term studies on the effects of recreational use of modafinil.
Observers have raised the idea that taking modafinil is cheating. It is like doping in sports, they say. And further, access to modafinil and other cognitive enhancers is easier to wealthier people than for poorer ones, further making things unfair.
A letter published in the Journal of the American Medical Association reported on a survey of US patients from 2003 to 2009, The authors found that most prescriptions were given for off-label uses. Doctors give it for multiple sclerosis, Parkinson’s Disease, and especially depression.
The drug company Cephalon was sued by several US states who alleged the company promoted off-label use in violation of industry rules. This suit resulted in an out-of-court settlement.
Pharmacological cognitive enhancement (PCE) with modafinil
Doctors are not supposed to prescribe medicines to people who are not sick, but patients can sometimes persuade them to give one anyway. Other people get modafinil from internet websites without a prescription.
Some enthusiasts take modafinil as part of a "stack". Stack recipes and regimens are shared among users often through internet message boards. The elements of the stack can include prescription medicines, dietary supplements, and over-the-counter drugs. For instance, piracetam, amino acids, and herbal remedies might be employed.
Some people are very sensitive to noise. Sound becomes intolerable. In experiments on mice, researchers found a combination of modafinil and the brain drug EBIO alleviated hypersensitivity. It had yet to be tried on humans.
Will insurance cover Modafinil? In general, yes, insurance policies treat Modafinil the same as any other prescription drug if it is for an approved use. Narcoleptics with good insurance can probably get it. Insurance companies know, however, that many prescriptions for Modafinil are off-label, and they may be wary of people buying this medicine if they suspect the intent it purely performance enhancement.
The Prevalence and Cost of Unapproved Uses of Top-Selling Orphan Drugs - article from PLOS.