Revised FDA Dosages for Popular Sleeping Pills: Lunesta and Ambien

sleeping pills

If you have taken or currently take the prescription pills Lunesta or Ambien, it’s important to know that the US Food and Drug Administration has lowered the recommended dose for these sleeping pills.

Lunesta and Ambien are among the most popular sleeping pills on the market. After taking them, the individual not only feels tired enough to fall asleep, but the pills help them stay asleep.

However, the US Food and Drug Administration (FDA) examined the frequency of occurrences of people that were still drowsy and lacked proper alertness the morning after taking these prescription sleeping medications, and decided to lower the dose. The agency believes that with a lower recommended dose, people taking these sleeping pills will still get the desired effect for sleep, but not be impaired upon waking, and be able to drive and work safely.

Lunesta

Lunesta, which was first approved by the FDA in 2004 as a treatment for insomnia, has had its dose adjusted by the FDA. The dose was previously set at 2 mg for men and women. Now, though, it has been adjusted to 1 mg for men and women, according to a May 2014 FDA news release.

The bottle will now suggest that people who do not see a positive effect from 1 mg can increase the dose to  2 or 3 mg, but that they should be aware of possible next-day drowsiness and impairment the following morning.

According to the FDA, approximately a million patients in the US are taking Lunesta, which is the brand name for eszopiclone. The new dosage applies to both to the brand name Lunesta, and generic forms of the drug.

The new decision comes after a study of 91 adults between 25 and 40 that showed severe impairments of memory and the ability to operate a motor vehicle the following morning when taking a 3 mg dose of Lunesta the night before. Signs of drowsiness of up to 11 hours after taking the drug were reported.

Ambien

Prior to Lunesta receiving its lowered recommended dose, the FDA reduced the recommended dosage on another prescription sleep medication, Ambien, which is the brand name for zolpidem.

The dose for Ambien was previously 10 mg for immediate-release Ambien, which includes Ambien, Zolpimist and Edluar, and 12.5 mg for extended-release Ambien CR. Ambien CR dosage was reduced to 6.25 mg and Ambien, Zolpimist and Edluar was reduced to 5 mg.  Like Lunesta, the FDA reduced the dosage to cut down on daytime drowsiness and reduce hazards while driving or at work.

While sleeping pills are generally considered safe to take, it is vital that people taking them follow the dosage recommendations. The FDA advises people to take the lowest dose possible to treat insomnia. Patients taking these medications should also speak to their health care professionals if unsure about the safe dosage amounts.

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