Labelling changes approved by the Food and Drug Administration

15th May 2013 - Fine Cut

The FDA (Food and Drug Administration) has approved a proposed labelling change to any sleeping medications containing zolpidem.

This will see labels for relevant medications changed to display a lower recommended dosage, as the pills' effects can continue into the 24 hours after a person first takes them.

The FDA itself asked manufacturers such as Novadel Pharma Inc and Meda a while ago to make changes to their labelling. Now, it has approved these companies' changes and, according to medicaldaily.com, this could reduce the risks associated with taking said medications.

A spokesperson for the Substance Abuse and Mental Health Administration, Pamela Hyde, seemed to welcome the news. In a statement, she said: "Although short-term sleeping medications can help patients, it is exceedingly important that they be carefully used and monitored.

"Physicians and patients need to be aware of the potential adverse reactions associated with any medication, and work closely together to prevent or quickly address any problems that may arise."

The FDA's recommended guidelines included a change to the suggested dose of fast and extended-releasing products, reuters.com revealed. For immediate-release drugs like Ambien, labels should recommend a five-milligram dose for women and a 10-milligram dose for men.

Extended-release drugs should be kept at a 6.25-milligram dose for females and for males, a 12.5-miligram dose. 

Categories: Articles
back to Insights