Friday, January 18, 2013

FDA Issues Sleep Aids Dosage Safety Announcement

 "Waking Up" to a TV ad

Television ads are designed to grab our attention. Did you ever notice that pharmaceuticals ads spend a lot of time discussing side-effects, warnings, and a suggestion not to start any new medication without first checking with your doctor and/or pharmacist?  This morning we saw a new ad for Intermezzo.


If you are having trouble viewing the ad, you can see it here. We shared the ad here, as it is a current example of a sleep aid medication and over the past week the news was filled with articles about a new FDA requirement regarding sleep aid medication.

FDA issues safety recommendation for women taking sleep aids containing zolpidem

You might be surprised to learn that Americans have been using sleeping aids containing zolpidem for just over two decades. These include products such as Ambien. The New York Times reports: "According to IMS, a health care information and technology company, about 60 million prescriptions were dispensed in 2011, up about 20 percent since 2006. About 40 million were for products containing zolpidem."

On January 10, 2013, the Food and Drug Administration (FDA) issued what they refer to as a "safety announcement" titled:  Risk of next‐morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist).

The FDA's website allows a viewer access to: drug facts, data summary, dosing recommendations, additional info for patients, additional info for Health Care Professionals and insomnia medicines. Importantly, the FDA's safety announcement points out:
"FDA urges health care professionals to caution all patients (men and women) who use these zolpidem products about the risks of next-morning impairment for activities that require complete mental alertness, including driving. For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men (see Data Summary)."
You might wonder if the FDA is requiring the manufacturers of other insomnia medicines to revise their dosing recommendations. Again, according to the FDA's frequently asked questions: "No. At this time, FDA is only requiring the manufacturers of certain zolpidem-containing products to revise their dosing recommendations. FDA is continuing to evaluate ways to lower the risk of next-morning impairment with other insomnia medicines."

Sleep is important for good health

We often talk about the importance of sleep. Wikipedia offers the following definition of sleep: "Sleep is a naturally recurring state characterized by reduced or absent consciousness, relatively suspended sensory activity, and inactivity of nearly all voluntary muscles. It is distinguished from quiet wakefulness by a decreased ability to react to stimuli, and is more easily reversible than being in hibernation or a coma. Sleep is a heightened anabolic state, accentuating the growth and rejuvenation of the immune, nervous, skeletal and muscular systems. It is observed in all mammals, all birds, and many reptiles, amphibians, and fish."

We recognize the importance of sleep regarding our health. We hear new parents wishing they could have one good night's sleep. Our friends and family members offer suggestions:
  • Don't eat after 8:00PM
  • Avoid caffeinated drinks in the evening hours
  • Sleep in a cool room
  • Turn off the television
  • Read a little before going to bed
  • Take a walk after dinner
  • Have a routine for bedtime which might include always trying to go to bed at the same time 
  • Have a routine morning wake-up time, don't change it on the weekends
At Cottonwood Tucson we promote an holistic approach to recovery, whether it is recovery from substance addictions and/or mood disorders. Good and balanced nutrition is important to our holistic approach to health. Carbohydrates, specifically complex carbohydrates, are the body’s main source of the amino acid tryptophan - a necessary precursor in the brain’s synthesis of the chemical messenger serotonin - used to facilitate a happy, stable mood, curb food cravings, increase pain tolerance and aid in sleep, all of these key components of a healthy recovery effort.

Going forward...

The FDA reports: In 2011, about 39 million prescriptions for zolpidem products were dispensed, and about 9 million patients received zolpidem products from U.S. outpatient retail pharmacies, of which 63% of the patients were female. Extended-release zolpidem products (Ambien CR® and generics) accounted for 11% (4.4 million prescriptions) of the zolpidem market, immediate-release products accounted for 89% (35 million prescriptions) of the market in Y2011.

We can watch television ads and try to absorb all of the information being provided; however, each patient needs to read the Medication Guide that comes along with any prescription for additional information and if you still have questions, then take the time to discuss them with your healthcare provider and/or pharmacist. 



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1 comment:

  1. This is interesting! At least now, we will see ads that are not only meant to advertise but also to deliver good information to the public. I hope this will not only be for sleep aids dosage but will also be true to other products.

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