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FDA Includes Safety Recommendations on Sleep Medication Product Labels

FDA Revamps Sleep Medication Product Labels

The U.S Food and Drug Administration decided to implement changes to product labels of commonly prescribed sleep medications. The FDA approved revisions to the labeling of zolpidem items to warn patients about possible next-morning impairments after using the drugs. Zolpidem products, such as Ambien, Ambien CR and Edluar, are extended-released medications that can hinder an individual's ability to drive or perform other activities that require the person's complete attention.

Custom Labels for Products Get Dosing Recommendations
The FDA says that applying custom labels for products with known risk of decreased alertness will increase consumer awareness about the medication. In January, the FDA had asked zolpidem manufacturers to reduce the dosage of the medication, recommending doses of 5 mg for women and 5 mg or 10 mg for men, according to Reuters. The news source cites that women have an increased risk of drowsiness after taking sleep medication, as the drug takes a longer time to leave a woman's system than it would a man's.

Changes to labeling medications have been instituted across the board, with sleep drugs just the latest to receive safety warnings.