FDA Warning: Sleep Medications May Cause Dangerous Side Effects


The U.S. Food and Drug Administration (FDA) will begin to require the manufacturers of sleeping medications called sedative hypnotics (listed below) to strengthen the warning labels on their products to let consumers know about two very rare but dangerous side effects: allergic reactions and complex sleep-related behaviors.

chart

The first side effects of sedative hypnotic medications are allergic-type reactions that involve difficulty breathing and may be accompanied by swelling of the tongue, a tight feeling in the throat or chest, or swelling of the face. This severe drug allergy can actually happen with any drug and is a medical emergency. Patients experiencing difficulty breathing should seek immediate medical attention.

The second reported side effects, although rare, are complex sleep behaviors including sleep-driving (in which the individual drives when not fully awake and has no memory of the event), making phone calls, and eating or cooking while asleep. The cause of these behaviors is unknown.

Remember, it can be dangerous to abruptly discontinue or to stop taking prescription medications. Always speak with your doctor if you have any concerning side effects and before making any changes to your drug therapy.


Back to top