Prescription Sleeping Pills to Carry New Warnings about Sleep-Driving

March 17th, 2007

The FDA warned in mid-March that all prescription sleeping pills have the potential to cause bizarre behaviors, such as “sleep-driving.” In extremely rare instances, patients have been known to get up in the night and drive, with no later memory of the event.

About one out of 1,000 persons on these medications has experienced unusual behaviors such as sleep driving, preparing and eating food, making phone calls, or even having sex while asleep. More common than middle-of-the-night excursions is driving while still feeling dangerously drowsy, for example, during an early morning commute.

Although extremely rare, another reported risk is a life-threatening allergic reaction and severe facial swelling. This side effect can occur with first use or anytime thereafter when the pills are taken. Seek immediate emergency treatment for such an occurrence.

Later this year, pharmaceutical companies that manufacture 13 prescription sleep medications will include new, extensive warnings in a special “medication guide” brochure. Some insomnia drugs may be riskier than others. The FDA has recommended clinical trials to compare their complications and frequencies with which they occur.

Ambien and a second drug Phenergan were implicated in sleep-driving headlines last year when Rep. Patrick Kennedy crashed into a barrier outside the U.S. Capitol building.  Kennedy stated that he did not recall being behind the wheel.

To lower the risk of sleep-driving and other risky behaviors, patients are advised never to take any prescription insomnia drug with alcohol or another sedating drug. Also, never exceed the recommended dosage.

The thirteen drugs for insomnia, so-called “sedative-hypnotics,” which will carry the new warnings are:  Ambien, Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; and Sonata.

Source:  CNN.com 

Entry Filed under: SLEEP DISORDERS, COGNITIVE DISORDERS, Amnesia, PRESCRIPTION DRUGS, SENIORS HEALTH