EasyDiagnosis Second Opinions Blog

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 manufacturers have no incentive to conduct clinical trials. Much better to raise the price of Provigil to $13.60 a pill, 50% more than Nuvigil, and hope for approval for treating jet lag at $9 a pill.*  In a clinical trial in 427 patients flown to France where they never got out of the lab (“food was miserable,” one participant said) showed that those who got the placebo took an average of only 3.4 minutes to fall asleep on the first day. 6.2 minutes, the second day, and 8.2 minutes the third day. Those who got the highest dose of Nuvigil stayed awake for an average of 9.7 minutes the first day, 13.8 minutes the second, and 14.8 minutes, the third day.

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 travelers going East, or “backward” in time zones,-moving their clock ahead, where jet lag is much more of a problem than for those going West or “forward” in time-moving their clock back. (Any comments?)