Driver threat: FDA urges lower doses of Ambien-like drugs

PHILADELPHIA — Driving is dangerous enough without falling asleep at the wheel, so the U.S. Food and Drug Administration on Thursday urged patients and doctors to lower the bedtime doses of a common insomnia drug, which was prescribed about 40 million times in 2011.

The new safety warnings are for the sleep drug zolpidem, which is sold as a generic and under the brand names Ambien, Ambien CR, Edluar and Zolpimist.

The new warnings came after clinical tests for a recently approved drug were coupled with tests involving driving simulators. The FDA will now require driving simulation tests be done as part of any new application for insomnia drugs.

IMS Health, a health care technology and information company, said about 60 million prescriptions were written for all sleeping pills in 2011, with about two thirds of those being some form of zolpidem.

Dr. Ellis Unger, a director in the FDA’s Center for Drug Evaluation and Research, urged patients to discuss the situation with doctors before changing any medication regime.

“We hope less of the drug will be in the bloodstream in the morning driving hours,” Unger said in a conference call with reporters.

Before it faced generic competition, IMS Health said, two versions of Ambien had nearly $2 billion in sales in 2007 for drug maker Sanofi-Aventis, which is based in Paris, but has big operations in New Jersey and a site in Malvern, Pa.

Teva Pharmaceuticals Ltd., which has big operations around Philadelphia, and Pittsburgh-based Mylan Pharmaceuticals, are the two largest generic drug makers and both list a generic version of zolpidem among their products.

Not all sleeping pills have zolpidem, but all FDA-approved drugs have label warnings about morning drowsiness. The agency said that extended release forms of zolpidem showed the highest risk for next-morning impairment and that women were more susceptible than men because the drug takes longer to flush from their system.

Usher said various reports of celebrities using Ambien around the time of car accidents did not influence the agency.

“The new information was not tied to any specific case,” Usher said, without naming names. But he added in reference to reports of celebrity accidents, “We don’t know the time of the accidents, we don’t know the last dosage or whether there was alcohol or other drugs involved.”

Talk to us

> Give us your news tips.

> Send us a letter to the editor.

> More Herald contact information.

More in Local News

A firefighter stands in silence before a panel bearing the names of L. John Regelbrugge and Kris Regelbrugge during the ten-year remembrance of the Oso landslide on Friday, March 22, 2024, at the Oso Landslide Memorial in Oso, Washington. (Ryan Berry / The Herald)
‘Flood of emotions’ as Oso Landslide Memorial opens on 10th anniversary

Friends, family and first responders held a moment of silence at 10:37 a.m. at the new 2-acre memorial off Highway 530.

Julie Petersen poses for a photo with images of her sister Christina Jefferds and Jefferds’ grand daughter Sanoah Violet Huestis next to a memorial for Sanoah at her home on March 20, 2024 in Arlington, Washington. Peterson wears her sister’s favorite color and one of her bangles. (Annie Barker / The Herald)
‘It just all came down’: An oral history of the Oso mudslide

Ten years later, The Daily Herald spoke with dozens of people — first responders, family, survivors — touched by the deadliest slide in U.S. history.

Victims of the Oso mudslide on March 22, 2014. (Courtesy photos)
Remembering the 43 lives lost in the Oso mudslide

The slide wiped out a neighborhood along Highway 530 in 2014. “Even though you feel like you’re alone in your grief, you’re really not.”

Director Lucia Schmit, right, and Deputy Director Dara Salmon inside the Snohomish County Department of Emergency Management on Friday, March 8, 2024, in Everett, Washington. (Ryan Berry / The Herald)
How Oso slide changed local emergency response ‘on virtually every level’

“In a decade, we have just really, really advanced,” through hard-earned lessons applied to the pandemic, floods and opioids.

Ron and Gail Thompson at their home on Monday, March 4, 2024 in Oso, Washington. (Olivia Vanni / The Herald)
In shadow of scarred Oso hillside, mudslide’s wounds still feel fresh

Locals reflected on living with grief and finding meaning in the wake of a catastrophe “nothing like you can ever imagine” in 2014.

Everett mall renderings from Brixton Capital. (Photo provided by the City of Everett)
Topgolf at the Everett Mall? Mayor’s hint still unconfirmed

After Cassie Franklin’s annual address, rumors circled about what “top” entertainment tenant could be landing at Everett Mall.

Everett
Everett man sentenced to 3 years of probation for mutilating animals

In 2022, neighbors reported Blayne Perez, 35, was shooting and torturing wildlife in north Everett.

Dorothy Crossman rides up on her bike to turn in her ballot  on Tuesday, Aug. 1, 2023 in Everett, Washington. (Olivia Vanni / The Herald)
Everett leaders plan to ask voters for property tax increase

City officials will spend weeks hammering out details of a ballot measure, as Everett faces a $12.6 million deficit.

Starbucks employee Zach Gabelein outside of the Mill Creek location where he works on Friday, Feb. 23, 2024 in Mill Creek, Washington. (Olivia Vanni / The Herald)
Mill Creek Starbucks votes 21-1 to form union

“We obviously are kind of on the high of that win,” store bargaining delegate Zach Gabelein said.

Lynnwood police respond to a collision on highway 99 at 176 street SW. (Photo provided by Lynnwood Police)
Police: Teen in stolen car flees cops, causes crash in Lynnwood

The crash blocked traffic for over an hour at 176th Street SW. The boy, 16, was arrested on felony warrants.

The view of Mountain Loop Mine out the window of a second floor classroom at Fairmount Elementary on Wednesday, Jan. 10, 2024 in Everett, Washington. (Olivia Vanni / The Herald)
County: Everett mining yard violated order to halt work next to school

At least 10 reports accused OMA Construction of violating a stop-work order next to Fairmount Elementary. A judge will hear the case.

Imagine Children's Museum's incoming CEO, Elizabeth "Elee" Wood. (Photo provided by Imagine Children's Museum)
Imagine Children’s Museum in Everett to welcome new CEO

Nancy Johnson, who has led Imagine Children’s Museum in Everett for 25 years, will retire in June.

Support local journalism

If you value local news, make a gift now to support the trusted journalism you get in The Daily Herald. Donations processed in this system are not tax deductible.