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

Girl, 11, missing from Lynnwood

Sha’niece Watson’s family is concerned for her safety, according to the sheriff’s office. She has ties to Whidbey Island.

A cyclist crosses the road near the proposed site of a new park, left, at the intersection of Holly Drive and 100th Street SW on Thursday, May 2, 2024, in Everett, Washington. (Ryan Berry / The Herald)
Everett to use $2.2M for Holly neighborhood’s first park

The new park is set to double as a stormwater facility at the southeast corner of Holly Drive and 100th Street SW.

The Grand Avenue Park Bridge elevator after someone set off a fire extinguisher in the elevator last week, damaging the cables and brakes. (Photo provided by the City of Everett)
Grand Avenue Park Bridge vandalized, out of service at least a week

Repairs could cost $5,500 after someone set off a fire extinguisher in the elevator on April 27.

Riaz Khan finally won office in 2019 on his fifth try. Now he’s running for state Legislature. (Kevin Clark / The Herald)
Ex-Democrat leader from Mukilteo switches parties to run for state House

Riaz Khan resigned from the 21st Legislative District Democrats and registered to run as a Republican, challenging Rep. Strom Peterson.

Shirley Sutton
Sutton resigns from Lynnwood council, ‘effective immediately’

Part of Sutton’s reason was her “overwhelming desire” to return home to the Yakima Valley.

Michelle Bennett Wednesday afternoon during a meet-and-greet with Edmonds Police Chief finalists at the Edmonds Library on August 4, 2021.  (Kevin Clark / The Herald)
Edmonds police chief accidentally fires gun inside police vehicle

Michelle Bennett was at a city fueling facility when her gun went off. Nobody was injured. Edmonds Mayor Mike Rosen was reviewing the incident.

Logo for news use featuring the municipality of Darrington in Snohomish County, Washington. 220118
Gunshot prompts massive police response near Darrington; ends peacefully

A man wanted for robbery fired a shot when deputies converged. Authorities shut down Highway 530 near Darrington. No deputies were injured.

Everett
Dog rescued, 10 displaced after apartment fire south of Everett

Fire crews rescued a dog from the third floor of an apartment building, where sprinklers confined the fire.

Marysville
Marysville man arrested in alleged murder conspiracy in Anacortes

Jesse Michael Allen, of Marysville, is the fifth suspect police believe participated in an alleged kidnapping in September.

Construction occurs at 16104 Cascadian Way in Bothell, Washington on Tuesday, May 7, 2024. (Annie Barker / The Herald)
What Snohomish County ZIP codes have seen biggest jumps in home value?

Mill Creek, for one. As interest rates remain high and supplies are low, buyers could have trouble in today’s housing market.

Rylee Fink, 3, left, stomps through the sand while other children run through the water during a low tide at Howarth Park on Tuesday, May 7, 2024 in Everett, Washington. (Olivia Vanni / The Herald)
Stock up on sunblock: Highs in 80s could be coming to Snohomish County

Everett could hit a high of 79 on Saturday. Farther inland, temperatures could reach as high as 86 this weekend.

Neighbors stand in Lisa Jansson’s yard to get a view of the wall of processed wood remains, or “hog fuel,” building up along the property’s border with DTG on Tuesday, March 5, 2024, in Snohomish, Washington. (Ryan Berry / The Herald)
After complaints, county shuts down DTG’s Maltby recycling facility

For months, neighbors have reported constant noise and pollution at the facility. By July 15, DTG must stop accepting material there.

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.