FDA: Lower insomnia product doses

Health officials say zolpidem levels could cause drowsiness next morning

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JACKSONVILLE, Fla. - The Food and Drug Administration is requiring manufacturers of insomnia products, such as Ambien, Edluar and Zolpimist, to lower their current recommended doses.

The FDA says it's because of an ingredient that is so strong, it could effect a person's commute to work the next day after taking it the night before.

"There's some medications that last longer in the body, so you do have what we used to call the 'hangover effect,' or the 'morning after effect' now," said Gary Roberts, of Roberts' South Bank Pharmacy.

The insomnia drugs contain an active ingredient called zolpidem, which causes drowsiness. Researchers have found high levels of zolpidem in the blood of some patients the morning after a dose -- so much so that it affects patients' cognitive skills, including their ability to drive.

"I think the FDA needs to do something like this to set a guideline so you know people will have something to follow," Roberts said of the new ruling.

The FDA says using lower doses of zolpidem will cut down on the amount of the drug found in the bloodstream the following morning. It's also recommended the dosage should be lower for women because they don't process zolpidem out of their system as quickly as men.

Patients who use the extended-release forms of these drugs have an even higher risk for next-morning impairment, according to the FDA.

The FDA said new labeling on the insomnia products will let doctors know they should consider a lower dose for men, especially for those who are having difficulty concentrating the next morning.

"No matter what dose you're on, when you wake up in the morning, if you don't feel like you're in full control, you don't get behind the wheel of your car," Roberts said.

There are other options besides prescribed insomnia products, such as over-the-counter sleep aids.

"There are some herbal remedies, milk, of course, melatonin is one, and there is another drug called Valerin that some people use," Roberts said.

Doctors say morning impairment is not limited to products with zolpidem. Drowsiness is a symptom listed on a number of insomnia drugs, and alertness may be impaired even if the person doesn't feel sleepy.

So check with your doctor when taking any sleep aid about the potential problems it could cause the morning after.

Ambien's manufacturers released a statement reacting to the new FDA requirement. They say: "As with all of our products, sanofi-aventis continues to closely monitor the safety profile of AMBIEN and we regularly communicate with Health Authorities as part of regular post-marketing safety evaluation of our products."

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