Off-label Use of Modafinil
While Modafinil is FDA-approved for narcolepsy, obstructive sleep apnea hypopnea syndrome and SWSD, many physicians are prescribing 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. This is in addition to trials proposed by manufacturers.
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 finals
- 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
Currently, many clinical trials are taking place to assess the effectiveness in using Provigil to treat other conditions than EDS associated with narcolepsy, OSAHS and SWSD. There have been no long term studies on the effects of recreational use of Provigil.
Will insurance cover Provigil? In general, yes, insurance policies treat Provigil 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 Provigil are off-label, and they may be wary of people buying this expensive 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.