A new disease is defined: “jet lag disorder,” so now, the new drug Nuvigil designed by Cephalon could become the first medicine to be approved by the FDA for combating sleepiness when traveling to distant time zones. Nuvigil is a slight modification of Provigil-sales $1 billion last year-which faces generic competition when the patent runs out in 2012. Both drugs are approved for severe sleepiness associated with narcolepsy, sleep apnea, and -surprise, another new disease, “shift work sleep disorder.” But by prescribing “off label” (unapproved indications by the FDA, but legal), the drugs have been dispensed widely for sleepiness associated with other conditions, or even for healthy people hoping to function on less sleep. That’s permissible for doctors, but promotion of off label use by the manufacturer is not. Cephalon pleaded guilty in 2008 and paid $443 million to settle federal and state charges that it had promoted Provigil and two other drugs for unapproved use.As also reported in the New York Times, stimulants like coffee and amphetamines are generic, so
It doesn’t look very impressive to me, at $18-$27 for 2-3 days treatment, plus the problem of reported side effects, including headaches, nausea, palpitations, jitters, anxiety, and some problems sleeping on subsequent nights. But maybe the FDA and then the public will go for it.
* The pills will be used only in