FDA: Sleeping pills may cause 'sleep-driving' - KLTV.com - Tyler, Longview, Jacksonville |ETX News

3/14/07-WASHINGTON

FDA: Sleeping pills may cause 'sleep-driving'

 All prescription sleeping pills may sometimes cause sleep-driving, federal health officials warned Wednesday, almost a year after the bizarre side effect first made headlines when Rep. Patrick Kennedy crashed his car after taking Ambien.

It's a more complicated version of sleepwalking, but behind the wheel: getting up in the middle of the night and going for a drive -- with no memory of doing so.

The Food and Drug Administration wouldn't say exactly how many cases of sleep-driving it had linked to insomnia drugs, but neurology chief Dr. Russell Katz said the agency uncovered more than a dozen reports -- and is worried that more are going uncounted.

Given the millions of prescriptions for insomnia drugs, Katz called the problem rare, and said he was unaware of any deaths. But because sleep-driving is so dangerous -- and there are precautions that patients can take -- the FDA ordered a series of strict new steps Wednesday.

First, the makers of 13 sleep drugs must put warnings on their labels about two rare but serious side effects:

  • sleep-driving, along with other less dangerous "complex sleep-related behaviors" -- like making phone calls, fixing and eating food, and having sex while still asleep.
  • and life-threatening allergic reactions, as well as severe facial swelling, both of which can occur either the first time the pills are taken or anytime thereafter.

Next, doctors this week will begin getting letters notifying them of the new warnings.

Later this year, all prescription sleeping pills will begin coming with special brochures called "Medication Guides" that spell out the risks for patients in easy-to-understand language.

Sleep-driving made headlines last May when Kennedy crashed his car into a security barrier outside the U.S. Capitol after taking Ambien and a second drug, Phenergan, which also acts as a sedative. He has said he had no memory of the event.

Ambien isn't the only insomnia drug that can cause sleep-driving -- any of the class known as "sedative-hypnotics" can, FDA's Katz stressed Wednesday.

To lower the risk of a sleep-driving episode, he advised patients to never take any prescription insomnia drug along with alcohol or another sedating drug, or take higher-than-recommended doses of the pills.

"We really want people to know these things can occur, and these sleep behaviors can be perhaps to a large extent mitigated by behaviors the patients can control," he said.

Some of the insomnia drugs may be riskier than others, so FDA also recommended that manufacturers conduct clinical trials to figure that out.

The drugs are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.

Copyright 2007 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed.

  • NewsMore>>

  • Tyler police searching for suspect accused of theft

    Tyler police searching for suspect accused of theft

    Saturday, May 26 2018 11:36 PM EDT2018-05-27 03:36:26 GMT

    Tyler police are looking for a theft suspect.  The theft occurred Saturday at 3300 Troup Highway.  The victim is described as a 85-year-old female. According to a report, the woman was followed into the restaurant by a Hispanic male. The male suspect then allegedly stole the victim's purse after she left it unattended.  A witness alerted the woman to the theft. The victim then checked the parking lot and discovered that her vehicle had been taken. The vehi...

    More >>

    Tyler police are looking for a theft suspect.  The theft occurred Saturday at 3300 Troup Highway.  The victim is described as a 85-year-old female. According to a report, the woman was followed into the restaurant by a Hispanic male. The male suspect then allegedly stole the victim's purse after she left it unattended.  A witness alerted the woman to the theft. The victim then checked the parking lot and discovered that her vehicle had been taken. The vehi...

    More >>
  • Veterans hold annual Buddy Poppy event

    Veterans hold annual Buddy Poppy event

    Saturday, May 26 2018 8:59 PM EDT2018-05-27 00:59:06 GMT

     In a tradition of spring, East Texas veterans organizations ask people to remember memorial day through accepting a symbol.  A flower.  Memorial day weekend, a time of reflection and honoring those who have fallen while serving our country.     The gift of a simple 'buddy poppy' has a deeply profound meaning for veterans. Thanks to a World War one officer. "The original story was written and thrown in the trash. John Mcrea dug ...

    More >>

    In a tradition of spring, East Texas veterans organizations ask people to remember memorial day through accepting a symbol. A flower. Memorial day weekend, a time of reflection and honoring those who have fallen while serving our country. The gift of a simple 'buddy poppy' has a deeply profound meaning for ve

    More >>
  • DPS: One dead in Smith County wreck

    DPS: One dead in Smith County wreck

    Saturday, May 26 2018 11:33 AM EDT2018-05-26 15:33:18 GMT

    From the Texas Department of Public Safety: On May 25, 2018 at 2:32 PM, Troopers responded to a two vehicle fatal crash on IH-20, 10 miles east of the city of Lindale.

    More >>

    From the Texas Department of Public Safety: On May 25, 2018 at 2:32 PM, Troopers responded to a two vehicle fatal crash on IH-20, 10 miles east of the city of Lindale.

    More >>
Powered by Frankly