FDA finally releases the study that confimrs that sleeping pills can cause ‘sleep-driving’
“All prescription sleeping pills may sometimes cause sleep-driving,” federal health officials warned Wednesday.
Sleep driving is a variation of sleepwalking. It involves getting in the car in the middle of the night, driving around, and with absolutely no memory of the drive.
The Food and Drug Administration wouldn’t say exactly how many cases of sleep-driving it had linked to insomnia drugs, but neurology chief Dr. Russell Katz said the agency uncovered more than a dozen reports — and is worried that more are going uncounted.
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 Wednesday.
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.
• and 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.
Next, doctors this week will begin getting letters notifying them of the new warnings.
Ambien isn’t the only insomnia drug that can cause sleep-driving — any of the class known as “sedative-hypnotics” can, FDA’s Katz stressed Wednesday.
To lower the risk of a sleep-driving episode, he advised patients to never take any prescription insomnia drug along with alcohol or another sedating drug, or take higher-than-recommended doses of the pills.
Some of the insomnia drugs may be riskier than others, so FDA also recommended that manufacturers conduct clinical trials to figure that out.
The drugs that the FDA seem concerned about are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.
I have long thought that some of my client’s behavior has been related to their prescription use. It is now nice to have a FDA study to back my contention. Now, if I could just get the officers on the APD DWI Task Force to read the FDA study.