Cephalon, who developed and currently sells Provigil, is busy right now on two fronts. First, they are working hard to protect their patents on Provigil from others who desire to produce and distribute the drug in generic form. This would seriously cut into Cephalon's future profits, which they've counted on from the start. Second, Cephalon is still working on studies in order to satisfy the FDA towards a more widespread approval.
As of last January, Cephalon asked the FDA to approve Provigil for treatments beyond narcolepsy (which currently is the only condition that the FDA has formally pronounced as appropriate for Provigil use.) Those other conditions are circadian rhythm disorders (hooray!), and depression. The FDA asked for mountains of clinical data, so Cephalon, at tremendous expense (investment), complied. The FDA is expected to take at least six more months before giving the go-ahead for more widespread use of Provigil. These studies were conducted by a wide range of potential users including shift workers, sleep-deprived military pilots in flight simulators, and persons suffering from restless leg syndrome.
If Cephalon gets its FDA approval, your friendly general practitioner will be able to prescribe Provigil for your sleep-related problems. Currently, only a sleep specialist or neurologist can prescribe it for narcolepsy. About 400,000 people now take Provigil, and that number is expected to rise to 40 million if more widespread use is approved.
Taking the supply factor aside for a moment, the next question is how the drug will be used. Because of the potential for abuse, some experts predict Provigil may become the next "lifestyle drug" (similar to Viagra and Prozac) that will be used to extend waking days and nights. But Dr. Anneke Heitmann of Circadian Technologies warns, "no pill should ever be a substitute for good fatigue management practices related to work schedule or on-site napping policies."
It won't take much imagination among shiftworkers to get their doctors to prescribe the pill, and they will probably even score some free samples. Currently, one of the big drawbacks of the drug is the cost, with some people spending as much as 400 dollars per month. They are certainly awaiting the introduction of the generics - assuming the drug actually works.
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