FDA Requests Label Change for "Sleeping Pills"
@trobert Health Guide
The FDA has has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
The medications covered by this labeling request are:
- Ambien/Ambien CR
- Butisol Sodium
- Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
- Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
FDA News. FDA Requests Label Change for All Sleep Disorder Drug Products. March 14, 2007.
Published On: March 14, 2007