U.S. FDA lowers starting dose of sleep drug Lunesta over safety

(Reuters) - U.S. health regulators on Thursday said they required a label change for the sleep drug Lunesta to cut the recommended starting dose over concerns it could impair alertness in some people the following morning. The Food and Drug...

"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,"

Related News

Anybody who has ever seen a drug advertisement or talked over the pros and cons of a medicine with a doctor can be forgiven for being confused. Sorting out the risks and benefits of taking a medicine can be complicated even for professionals. i i hide captionThis 2007 ad for the sleeping pill Lunesta stresses insomnia relief — not the relative usefulness of the drug. 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...

The Food and Drug Administration is worried that a sleeping pill you take tonight could make for a riskier drive to work tomorrow. In its latest effort to make sure that the millions of Americans who take sleep medications do not drowsily endanger themselves or others, the agency on Thursday said it will require the manufacturer of the popular drug Lunesta to lower the...

Travel deals Because insomnia and poor sleep are major health complaints for older adults, people 50 and older are most likely to receive a prescription for a sleep aid. If you are taking Lunesta, be aware that the Food and Drug Administration is requiring the sleeping pill's manufacturer to lower the recommended starting dose on the label to 1 mg from 2 mg. The FDA says...

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...

These new medications—known as dual orexin receptor antagonists (DORA)—target a more specific region of the brain than popular sleep drugs such as Ambien and Lunesta, promoting sleep without affecting learning and memory (also called "cognition"), according to the new research. "We've shown that these compounds improve sleep at doses that don't impact cognition," said Jason...

Eszopiclone is a short acting nonbenzodiazepine sedative hypnotic. According to its manufacturer, it has been shown to be safe and effective for the short term treatment of primary insomnia in the elderly and safe in younger adults for 6–12 months. All clinical trials of eszopiclone published so far have been funded by the manufacturer of eszopiclone, Sepracor. There were 43 million prescriptions issued for insomnia medications during 2005 in the USA which generated a total of $2.7 billion for pharmaceutical companies. Eszopiclone (Lunesta) along with other "Z Drugs" including zolpidem (Ambien), zaleplon (Sonata) are the most commonly prescribed sedative hypnotics in the USA.

Eszopiclone is not marketed in the European Union following a 2009 decision by the EMA denying it new active substance status, in which it ruled that eszopiclone was too similar to zopiclone to be considered a new patentable product.