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Dosages of Ambien and other sleeping pills to be halved after study links increased risk of car accidents to morning drowsiness  with women at greater risk than men

The FDA is forcing manufacturers of zolpidem, commonly sold as Ambien, to reduce recommended dosages after tests found it stays in the bloodstream

Tests also found that women process the drug much slower than men 

Ambien is the most widely prescribed sleeping aid in the U.S.

It has been blamed for several recent high-profile driving accidents, including Tom Brokaw and Kerry Kennedy

By Daily Mail Reporter

Published: 17:43 BST, 11 January 2013 , Updated: 17:46 BST, 11 January 2013




The Food and Drug Administration has announced that it will require manufacturers of zolpidem, a popular sleeping pill commonly sold as brands including Ambien and Edluar, to reduce recommended dosages amid concerns about morning drowsiness caused by the pills.

New research released Thursday shows that the drugs remains in the bloodstream at levels high enough to interfere with alertness and coordination, which increases the risk of car accidents.

Regulators are ordering drug manufacturers to cut the dose of the medications in half for women, who process the drug more slowly.

Hidden dangers: New research shows that zolpidem remains in the bloodstream at levels high enough to interfere with alertness and coordination

The FDA has recommended drug companies reduce the recommended dosage of Ambien because it causes morning drowsiness

Doses will be lowered from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations.

The FDA is recommending that manufacturers apply these lower doses to men as well, though it is not making them a requirement.

A Scripps Health study published in the British Medical Journal last year found that sleeping pill usage may have contributed to as many as 500,000 'excess deaths' in the United States in 2010,  and noted that sleeping pill users have a fivefold increased risk of 'early death.'





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The new doses apply to all insomnia treatments containing the drug zolpidem, which is sold under different brands including Ambien, Edluar, Zolpimist, Stilnox, Sublinox and in generic forms.

It is the most widely prescribed sleeping aid in the U.S. The changes don't affect other popular sleeping medicines like Lunesta and Sonata, which use different drugs.

FDA officials pointed out that all sleeping drugs carry warnings about drowsiness.

Morning drowsiness caused by sleeping pills containing zolpidem has been found to interfere with alertness and coordination, increasing the risk of car accidents

Ambien has been blamed for high-profile driving accidents involving Tom Brokaw and Kerry Kennedy

‘All sleep drugs have the potential to cause this, so health professionals should prescribe - and patients should take - the lowest dose that is capable of preventing insomnia,' said Dr. Ellis Unger, a director in FDA's Office of Drug Evaluation.

Unger added that the FDA will begin requiring developers of sleep drugs to conduct driving simulation studies going forward.

Ambien has been blamed for several recent high-profile driving accidents in the past year, including Tom Brokaw in September and Kerry Kennedy in July.

The FDA has received more than 700 reports of driving-related problems connected to zolpidem over the years.

‘But in most cases it was very difficult to determine if the driving impairment was actually related to zolpidem,' Unger said. ‘Usually the reports did not contain information about when the accident happened or how much time had lapsed since taking the drug.'

The agency decided to take action after recent driving simulation studies showed that, in some patients, drug levels remained high enough to cause difficulty driving. The data came from company studies of Intermezzo, a new form of zolpidem which was approved in 2011 for people who wake late at night and can't get back to sleep.

The data showed that 33 percent of women and 25 percent of men taking extended-release zolpidem had enough of the drug in their blood to interfere with driving as much as eight hours later.

Zolpidem is present in sleeping aids including Zolpimist and has been found to have a much stronger effect on women than men

When the dose was cut in half only 15 percent of women and five percent of men had those same drug levels.

FDA analysis was unable to determine why women metabolize zolpidem so much more slowly than men. According to FDA staff, the difference cannot be accounted for by usual factors like size and weight.

For now, patients should continue taking their currently prescribed dose until they can talk to their doctor about the best way to proceed.

‘We really don't want people to change the dose they're on. We want them to talk to their health care provider,' Unger said.

Ambien is marketed by Sanofi, Intermezzo by Purdue Pharma LP and Zolpimist by NovaDel Pharma Inc.


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