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FDA seeks to learn more about drugs that may cause drowsy driving

When evaluating the safety of a drug intended to help people get to sleep, the U.S. Food and Drug Administration first looks at whether the drug does what it is intended to do safely. An emerging safety concern, however, is whether the drug can cause drowsiness the morning after use. The fear is that users may be getting behind the wheels of their cars even though they may be impaired and pose a serious threat of causing a car accident.

It is clear that the FDA is taking these safety concerns seriously. Earlier this summer, the FDA refused to approve the sleep aid suvorexant, which is produced by Merck. The rejection was caused by numerous studies finding that people who used the drug had trouble driving safely the following day. The FDA also required that the manufacturers of Ambien, also known as zolpidem, reduce the dosage intended for women by half. 

The FDA is not only concerned about sleep aids. In May of this year, it warned consumers to think twice about driving on mornings after evenings when they had taken allergy medications such as Benadryl. In some cases, these drugs can affect a person’s ability to drive safely even after a good night’s sleep.

A big part of the problem with these drugs is that many people simply ignore warnings on labels to avoid driving or operating heavy machinery after taking a dose. Although the FDA is attempting to address this emerging problem the best it can, it also needs consumers to be more attentive about their own medications. 

Source: New York Times, "To Judge Sleep Aids, U.S. looks at Drowsy Driving in the Morning," Katie Thomas, Aug. 13, 2013. 

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