The Associated Press
updated 9/25/2003 8:52:57 AM ET 2003-09-25T12:52:57

A U.S. advisory panel Thursday recommended approval of Cephalon Inc.’s drug Provigil to combat excessive sleepiness due to shift work or severe snoring that causes individuals to wake frequently. But the Food and Drug Administration advisers split 4-4 on whether Cephalon should be allowed to market Provigil more broadly for excessive sleepiness from other sleep disorders.

  1. Don't miss these Health stories
    1. Splash News
      More women opting for preventive mastectomy - but should they be?

      Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

    2. Larry Page's damaged vocal cords: Treatment comes with trade-offs
    3. Report questioning salt guidelines riles heart experts
    4. CDC: 2012 was deadliest year for West Nile in US
    5. What stresses moms most? Themselves, survey says

THE FDA USUALLY follows the advice of its advisory panels.

Provigil already is approved for treating narcolepsy, a rare condition that causes uncontrollable sleeping during waking hours.

Trading in shares of West Chester, Penn.-based Cephalon were halted during the FDA panel meeting.

Provigil’s growing sales suggest the drug already is being prescribed beyond its approved use as word has spread that it can keep people awake and alert.

Doctors are free to prescribe medicines for any purpose once they are on the market.

Sign up for our health e-newsletter
Sales of Provigil rose 40 percent in the second quarter of 2003 to $69.5 million, from the prior-year period. The company acknowledges that most prescriptions likely are not written for narcolepsy.

The company said its studies showed Provigil, known generically as modafinil, helped shift workers and people with sleep apnea stay awake with mild to moderate side effects including headaches.

The FDA panel was unanimous in recommending Provigil for treating excessive tiredness caused by sleep apnea and voted 6-2 for its use in treating shift workers.

Provigil targets a part of the brain that controls sleep and waking, but researchers do not know exactly how it works.

© 2003 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters.

© 2005 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


Discussion comments


Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments