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Regulatory Focus™ > News Articles > FDA Finalizes Changes to Sleep Drug Labeling to Alleviate Risks of Impaired Driving

FDA Finalizes Changes to Sleep Drug Labeling to Alleviate Risks of Impaired Driving

Posted 15 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has finalized labeling changes for zolpidem-containing products, the main ingredient in the sleep-aid drugs Ambien CR and Edluar, after issuing a warning earlier this year regarding the potential for those products to impair next-morning activities, especially in women.


FDA's January 2013 announcement on zolpidem required manufacturers to submit labeling changes to the agency that reduced the recommended daily intake for the drug. Unusually, FDA's announcement generally left dosing recommendations for men who take the product unchanged. Men who took the product at either the 10 mg or the 12.5 mg dose level had the option of either staying at that dose, or having a doctor prescribe them lower doses of 5 mg or 6.25 mg per day.

The labeling for women, however, would reflect new dose recommendations that were exactly half of what they were previously (from 10 mg to 5 mg and 12.5 mg to 6.25 mg, respectively).

Regulators said the change was spurred by reports that some patients, and women in particular, experienced impaired motor skills and reaction times the morning after taking the drug, putting other people at risk if the patient were behind the wheel of a vehicle.

"Over the years, FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people's mental alertness and ability to drive," Ellis Unger, director of the Office of Drug Evaluation, said. "Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment."

"To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient's insomnia," said Unger. "Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate."

Changes Approved

The new requirements, he said, are aimed at making sure patients wake up with a reduced amount of zolpidem remaining in the blood stream, reducing the chance that they will get into an accident or otherwise harm themselves or others by participating in an activity while impaired. "In some individuals, zolpidem blood levels the morning after use appear capable of impairing driving to a degree that increases the risk of a motor vehicle accident," FDA officials wrote.

And as of 14 May 2013, those changes to the drug's labeling have come into effect, FDA announced. Affected drugs include Sanofi's Ambien and Ambien CR, Meda Pharmaceuticals' Edluar and Novadel's Zolpimist, a spray version of the drug. Another drug, Intermezzo, a lower-dose zolpidem product, already meets the proposed changes, FDA said.

A press call in January 2013 on the changes indicated that FDA would require similar sleep drugs to submit driving study data to the agency in order to support approval. One such driving simulation study would be sufficient to support approval so long as "it is conducted well," Unger said on the call. 

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