Given the millions of prescriptions for insomnia drugs, Katz called the problem rare and said he was unaware of any deaths. But because sleep-driving is so dangerous — and there are precautions that patients can take — the FDA ordered a series of strict new steps yesterday.
First, the makers of 13 sleep drugs must put warnings on their labels about two rare but serious side effects:
Sleep-driving, along with other less dangerous “complex sleep-related behaviors” — like making phone calls, fixing and eating food, and having sex while still asleep.
Life-threatening allergic reactions, as well as severe facial swelling, both of which can occur either the first time the pills are taken or anytime thereafter.
