Dangers of Sleep Aid reduced by a label change?
Yesterday, the FDA approved the sleep aid Intermezzo. It is intended for those who wake up during the night and have trouble falling back asleep. In an article posted in WebMD, we learn that the FDA had twice refused to approve the drug based on concerns about individuals getting up and driving after taking the [...]
Yesterday, the FDA approved the sleep aid Intermezzo. It is intended for those who wake up during the night and have trouble falling back asleep. In an article posted in WebMD, we learn that the FDA had twice refused to approve the drug based on concerns about individuals getting up and driving after taking the drug and before the effects fully wear off.
In response, the manufacturer, Transcept Pharmaceuticals, changed the label to say it should only be taken if you have at least four hours to sleep and five hours until you drive when you take Intermezzo. What is odd to me is that the danger is still there– there’s just a labeling change. If everyone read and followed directions, then everything may be fine. But typically inserts and labels are thousands of words long. If the drug is taken too late in the night– problems can still arise.
Sleep is such an important part of our day and the suffering of those who have trouble sleeping is considerable. Insomniacs have a new tool at their disposal and if properly administered, it may help make the most of those precious hours of sleep. Personally, with three little kids around, days are so hectic that falling to sleep isn’t a problem. Although I’ve used our Sleep Tite now and again to encourage a deeper night’s sleep, especially when I know I really need the rejuvenation.
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