FDA Okays First Middle-of-the-Night Insomnia Drug

FDA Okays First Middle-of-the-Night Insomnia Drug

November 28th, 2011 // 1:20 pm @

Is there anything worse than waking up in the middle of the night and not being able to go back to sleep? Okay, lots of things, but for people who do it and hate it, the U.S. Food and Drug Administration (FDA) has, for the first time ever, approved a drug to treat middle-of-the-night insomnia.

According to the FDA, the newly approved prescription sleep aid drug, called Intermezzo (zolpidem tartrate sublingual tablets), should be used only when the person taking it can devote at least four more hours to staying in bed and should never be taken after drinking alcohol or in combination with any other sleep aid.

The sleep-inducing ingredient of Intermezzo — zolpidem tartrate – was first approved by the FDA in 1992 as the all-night sleep aid drug Ambien. Intermezzo includes a lower dosage of zolpidem than Ambien.

“For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking,” said the FDA’s Dr. Robert Temple, M.D., in a press release “With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.”

Side Effects? You bet! FDA advises that Intermezzo “like other sleep medicines,” can cause some seriously bizarre side effects like getting out of bed while still partially asleep and doing things you don’t remember doing later. According to the FDA, people under the influence of sleep medications have reported waking up to discover they had driven cars, cooked and eaten meals, taken walks outside, talked on the phone and had sex – without being aware of their actions at the time or remembering them later.

The most commonly reported adverse reactions to Intermezzo in its clinical trials were headache, nausea and fatigue. Since it can be abused and lead to dependence, Intermezzo is classified by the FDA as a federally controlled substance, available by prescription only.

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