Sleep Aid Medication Not Safe Enough Says FDA

Regulators at the US Food and Drug Administration have denied for a second time, a sleep aid drug over safety concerns.  Trancept Pharmaceuticals formulation of zolpidem tartrate (the same drug used in Ambien) has been trying to get approval for a sublingual tablet they hope to market as "Intermezzo".  This sleep aid would be marketed towards those who wake in the middle of the night and can't get back to sleep.  

The problem is regulators have doubts over safety.  Taking a dose of this drug with less than 4 hours of sleep time may result in severe morning drowsiness.  The stories of sleep driving, sleep walking and sleep falls have all been documented and are receiving attention. 

Driving While Drowsy is Unsafe

According to the Centers for Disease Control and Prevention, drowsy driving contributes to an estimated 100,000 motor vehicle crashes and about 1,500 deaths each year.

In fact,  in 2007, FDA regulators requested that all manufacturers of sedative-hypnotic drugs include stronger product language warning of the potential risks because of the rising number of sleep driving incidents.

Waking in the middle of the night is a pattern is sleeplessness that is one of the most common problems today. If you saw the Dr. Oz show on Chinese Medicine (you can see it here) you probably heard that jujube seed is an herb which can help with this sleeplessness. 

This 100% natural herbal sleep aid that has been used for thousands of years throughout Asia, yet is little known in the West. It is effective and safe!  Research has proven it's ability to calm the mind and stop the repetitive thoughts that so often keep us awake at night.  It is one of the main herbs in iSleep Herb Pac.   iSleep can be used sublingually before bed or in the middle of the night.   There are no harmful side effects and no morning drowsiness.  You can find iSleep Herb Pac here and at many fine health food stores.

One thought on “Sleep Aid Medication Not Safe Enough Says FDA

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