The FDA has announced that it is requiring the manufacturer of Lunesta, a popular sleep aid, to change the drug label and lower the current recommended starting dose out of concern that it may impair some users' abilities to perform activities the morning after usage, even if they feel fully awake.
The recommended starting dose for Lunesta has been reduced from 2 mg to 1 mg for both men and women. The lower starting dose will mean that less of the drug remains in the bloodstream the next morning. Users who are currently taking the 2 mg and 3 mg doses of Lunesta should contact their doctors for instructions on how to proceed.
The dose change follows a study that showed that Lunesta 3 mg is associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug. The study found that the recommended doses can lead to impaired driving skills, memory and coordination up to 11 hours after the drug is taken. Many users were unaware that they were impaired.
The dosage and label changes will also apply to generic versions of Lunesta.
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