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FDA lowers Lunesta dose: Next morning impairment seen with higher dosages

FDA lowers starting dose of Lunesta after "severe" impairment seen the next morning when higher dosages used the night before.
FDA lowers starting dose of Lunesta after "severe" impairment seen the next morning when higher dosages used the night before.
Lunesta/ Facebook

The FDA has just lowered their recommended dosage for the sleep aid Lunesta after reports of drowsiness the next morning spark concerns of causing interference with the patient’s drive to work. The original recommended dosage was a two milligram pill at night before bed, but that has been cut in half and the new dosage is a one milligram pill at bedtime, according to Fox News on May 16.

There’s nothing like a good night’s sleep, but for many a sleep aid is needed to award them those precious hours of slumber. The problem starts when it’s hard to wake-up in the next morning because you are in a drowsy haze. Driving to work impaired like this can be dangerous and unfortunately this can be a side effect of any sleep aid.

Other sleep aids have seen their recommended dosage lowered within the last year, like Ambien. Starting folks on a two milligram pill of Lunesta was shown to impair alertness in some people the next morning, reports ABC News.

While the two milligram and three milligram dosage of the sleep medication is still available, it will be the individual’s prescribing physician to make a determination on what the patient needs. The FDA is recommending that a patient is started on a one milligram dosage, instead of a two milligram dose when the medication is prescribed to someone who has never taken the drug before.

A study showed that Lunesta in a three milligram dosage was associated with “severe next-morning psychomotor and memory impairment in both men and women.” The study also showed that a patient can have impairment in driving skills and memory without realizing this is the case.

These side effects that render the patient drowsy and impairing the patient were shown to last up to 11 hours after the pill was ingested. Again, there was little awareness on the part of the patient that this was the case, making it an even more dangerous situation.

Most folks wouldn’t get behind the wheel of a car impaired, but if they don’t recognize that they are not functioning with a normal level of alertness, they would have no qualms about driving. The FDA is allowing the one milligram dose to be increased to two or three milligrams if needed and at the discretion of the prescribing doctor.

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