FDA Alert: FDA Requests New Warnings on Sleep Aids

The FDA has requested that the warning labeling be strengthened on 13 sedative-hypnotic sleep aids. Risks to be highlighted include anaphylaxis, angioedema, and what the agency calls “complex sleep-related behaviors” such as driving, eating, and making phone calls while not fully awake. Manufacturers of the drugs — which include Ambien, Halcion, Lunesta, and Sonata — will begin sending out letters to healthcare providers discussing the new warnings and will develop patient medication guides to be handed out when the drugs are dispensed.

The FDA has also recommended that manufacturers conduct studies to determine the risks for specific complex sleep behaviors on a drug-by-drug basis.

The FDA press release is available online.