FDA announces stronger warning label requirements on sleeping pills
AUSTIN, Texas (FOX 7 Austin) - On Wednesday the U.S. Food and Drug Administration announced it is now requiring stronger warning labels on sleeping pill bottles.
Tom Schnorr, a pharmacist for 38 years, owns and works at Austin Compounding Pharmacy.
"The box label is a notice from the FDA to put responsibility on me as a practitioner and the doctor so we tell you as a patient this is a concern,” Schnorr said.
The agency says commonly used sleeping pills like Ambien, Sonata and Lunesta must now list potential side effects.
"We can no longer just casually mention, 'oh by the way you might have sleep walking', now we're going to say we guarantee it,” Schnorr said.
According to the Centers for Disease Control, 9 million Americans currently take sleeping pills. The new regulations come after several reports of sleepwalking, overdoses and even death of patients, a change Schnorr says should have come much sooner.
"This has been going on for ten years," Schnorr said. "The drug's been on the market for 15."
The FDA says it will also tighten restrictions on doctors prescribing sleep medications. Schnorr says dangerous side effects generally take place when there's misuse, usually using the medication more than three times a week.
"I have patients that are using two or more a day for weeks or months on end and I ask them if they wake up and find any bags from Walmart or any wrappers from Jack in the Box and McDonalds as in you're going and driving your car and not remembering it," Schnorr said. "They go oh my God I thought it was you, and I said you're having amnesia and sleepwalking. That's one of the risks you're taking a drug for too long."
Schnorr says that's when he takes off his pharmacist hat and puts on his nutritionist hat and suggests more natural ways to help the body, like melatonin, 5-HTP, or B-vitamins.
"I have some people that have two scoops of Epsom salt and just soak in a bath which instantly relaxes them," Schnoor said.
As for the new box labels, Schnorr says his pharmacy will probably receive them within the next week or so. When asked if he thinks the new labels will change anything, he said no.
“No I don't I'm sorry I'm a realist I've been doing this too many years," Schnorr said. "We'll give you a piece of paper and you'll just put it in the trash."