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DOH calls for labels on rare sleeping pill effects

There will soon be stronger warning labels on Ambien and six other brands of sleeping pills, alerting consumers to potential side effects including short-term amnesia and "sleep-driving."

The Department of Health's (DOH) Bureau of Pharmaceutical Affairs swiftly followed in the footsteps of the US Food and Drug Administration (FDA), which on Wednesday ordered the makers of 13 products to strengthen warnings on their labels about two rare but serious side effects: Sleep-driving and other "complex sleep-related behaviors," such as making telephone calls or fixing and eating food while asleep; and life-threatening allergic reactions and severe facial swelling, both of which can occur the first time the pills are taken.

This entire class of medicine, known as sedative-hypnotic products, pose these rare risks, the FDA said.

But some drugs may pose a higher risk than others. For this reason, the FDA recommended that manufacturers conduct clinical trials testing the risks posed by specific drugs.

The drugs that pose risks include Ambien, Butisol sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal and Sonata.

Bureau of Pharmaceutical Affairs Director Liao Chi-chou (廖繼州) urged doctors to carefully weigh the pros and cons of prescribing sleeping pills and to inform patients about the potential side-effects and what products to avoid while using the drugs.

"Taking Ambien while there is alcohol in your system causes a multiplier effect where one plus one might equal three" Liao said yesterday.

"It is a dangerous combination that can result in death is some cases," Liao said.

Wang Chun-yu (王春玉), director of Shinkong Hospital's pharmaceutical department, said 11,000 Ambien pills are proscribed each month at Shinkong alone.

"In terms of volume, it's our most popular sleep aid," Wang said. "Doctors and patients favor it because it is less likely to cause dependency and leaves little residual drowsiness the next day."

"I think every doctor who has prescribed Ambien has come across those side-effects in patients," said Chen Ning-hung (陳濘宏), director of the Taiwan Society of Sleep Medicine. "The elderly seem especially prone."

Chen said he had had patients who experienced sleepwalking and amnesia while taking the drug.

"They have no recollection of what they have done until being told by their families," he said, adding that the fast-acting drug can take effect in as little as 10 minutes.

"I tell my patients to take it at their bedside because if they take it before they have brushed their teeth they might end up on the bathroom floor," Chen said.

In the US, the FDA has told manufacturers to write to doctors to notify them of the new warnings.

All prescription sleeping pills will now come with special brochures called "Medication Guides" that spell out the risks for patients in easy-to-understand language.

The FDA did not say exactly how many cases of sleep-driving it uncovered, or if it knew of any car crashes, saying only that "there have been rare adverse events reported."
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