Screenshot of FDA Label Warning

FDA Issues Warning on Sedative/Hypnotics

In March 2007, the FDA issued a request for a label change for all sedative-hypnotic drugs, which are sleep drugs. The FDA requested that they use stronger language concerning the potential risks of these drugs, which include "complex" sleep-related behaviors such as sleep-driving, making phone calls, and preparing and eating food while asleep.

Among the most recognizable medications whose labels needed to be changed were:

The FDA requested that each sleep medication manufacturer send letters to health care providers and notify them about the new warnings.

Along with the labeling revisions, the FDA also requested that the manufacturers develop Patient Medication Guides to go along with their prescriptions. Patient Medication Guides are handouts included in the package of the medication. The guides were meant to inform consumers about the risks and offer advice as to precautions that should be taken before taking the medication.

Because it wasn't sure what the differences in reactions were among the products, the FDA recommended that the drug manufacturers conduct clinical studies to determine the frequency of sleep-driving and other complex behaviors associated with the individual drug products.