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FDA halves recommended Lunesta dose, warns effects can persist into next day

Lunesta

(CNN) — Lunesta may help you doze off at night, but it’s the morning after that has officials concerned — which is why on Thursday they halved the recommended dosage for the well-known sleep aid.

The U.S. Food and Drug Administration cited data showing that a person may be less alert and do things such as driving less safely the day after taking Lunesta.

In particular, the federal agency pointed to one study of 91 healthy adults between the ages of 25 and 40, some of whom were given 3 mg of Lunesta, while the others got a placebo, or inactive pill.

Men and women who took the active drug had “severe next-morning psychomotor and memory impairment” some 7½ hours later, as well as “impairment to driving skills, memory and coordination as long as 11 hours after the drug is taken,” according to an FDA news release.

As a result, the FDA decided to decrease the recommended starting dose of Eszopiclone, as sold by Sunovion under the brand name Lunesta, from 2 mg to 1 mg.

The federal agency noted that health care professionals could increase the dosage as high as 3 mg while warning of the consequences.

“To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,” said Dr. Ellis Unger, a drug evaluation director at the FDA.

Sunovion, the company that makes and markets Lunesta, did not immediately respond Thursday to CNN requests for comment on the recommended dosage change.

According to the product’s website, Lunesta is “the No. 1 prescribed branded sleep aid,” with more than 31 million prescriptions for the drug written. The same site states that “more than 30 studies” have shown Lunesta “to be effective in many different types of insomnia patients,” adding that “there are no restrictions on duration for taking Lunesta.”

1 Comment

  • Chrystal

    I took Lunesta for over 4 yrs., yes it did help but it did cause me to do some strange things. I was a college student on line and needed to retake a test due to a mistake the test locked me out. I said to myself, “I got to contact the instructor so she can let me back in, “ll do it tomorrow”! I then took my pill and went to bed! The next day I went to send the instructor an email and saw what looked like a reply from her. It said “Okay”! I said, “Okay what”? Then I scrolled down to see what looked like an email sent to her written by a 6 yr. old, only it came from me! It had no punctuation and broken words worse then texting! It was also written about 2:30 in the morning, heck I didnt do that I was sleep, So I thought! It was obvious to me that I had been sleep walking and performed the last thing on my mind. Also I would only awake to either a bell ringing or the sound of a hand clap! None of the situation “I felt” were to serious so I didn’t worry about them. The good thing was after 4 yrs or so I was returned to my normal sleep pattern! Also let me say that I never slept over 71/2 hrs. and when I awoke, I could hop right out the bed without any drowsyness!

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