Most people are aware that sleep deprivation can have a dangerous effect on driving ability. In some cases sleep deprivation can impair your abilities as much as alcohol. Many people are not aware of the residual effects of sleep medications on driving ability the next day.
Sleep experts warn that people should exercise caution before deciding to take medication to help them sleep. Health officials are concerned that medication levels can remain high enough in the blood that people can have trouble driving the next morning.
Earlier this year the US Food and Drug Administration announced it is requiring the manufacturer of Ambien and Zolpimist to cut the recommended dosage for women in half, after laboratory studies showed that the medicines can leave patients drowsy in the morning and at risk for car accidents.
The agency decided to take action after recent driving simulation studies showed that, in some patients, drug levels remained high enough to cause difficulty driving. The FDA recommended that manufacturers extend the new dosage cuts to men as well, who process the drug at a faster rate; however, the reasons men and women catabolize the drugs at different rates are still unknown.
In May 2013, the FDA approved label changes specifying new dosage recommendations for zolpidem products (brand names Ambien, Ambien CR, Intermezzo, Stilnox, Sublinox and Zolsana), because of concerns regarding next-morning impairment.
The market for sleeping medications has increased dramatically in recent years. 60 million total prescriptions written for all sleep medications in 2011, contributing to a $1.6 billion market. Popular sleeping drugs include zolpidem, as well as eszopiclone (Lunesta), temazepam (Restoril), and triazolam (Halcion). Since its approval in 1992 for the treatment of insomnia, zolpidem has been the best-selling sleep medication – a trend that continues to climb. Prescriptions for all forms of zolpidem have increased in 29.8 percent from 2007 to 2011, with 44.8 million prescriptions written in 2011, 95 percent of which are for the generic version.
The main danger from sleep medications is usually a result of people driving too soon after taking the drug. Package inserts recommend at least seven to eight hours of sleep before engaging in activities such as driving. The developer of the sleeping pill Ambien, Sanofi-Aventis, says it stands behind the safety and efficacy of Ambien “when used as directed”.
Despite this warning, many people may be driving before the drug is out of their system. In an American study the data showed that 33 percent of women and 25 percent of men taking extended-release zolpidem had enough of the drug in their blood to interfere with driving as much as eight hours later.
One recent study from the Netherlands revealed that “benzodiazepine hypnotics significantly impaired driving ability the morning following bedtime administration. Impairment was sometimes also significant in the afternoon (16-17 hours after administration). Similar driving impairment was observed with zopiclone. However, the magnitude of impairment depends on various factors including the half-life and dosage of the drug, and the time after administration. The results from on-the-road driving studies are supported by evidence obtained in driving simulators and laboratory tests. Epidemiological data and on-the-road studies show that tolerance develops to the impairing effects of hypnotics. However, this is a slow process, and impairment may persist. Patients treated with benzodiazepine hypnotics or zopiclone should be cautioned when driving a car." See http://www.ncbi.nlm.nih.gov/pubmed/15233958
Ambien has been blamed for several recent high-profile driving accidents in the past year, including Tom Brokaw in September and Kerry Kennedy in July. Personal injury lawyers acting for the injured plaintiff should always question and review the medication history of the defendant. The goal is to assess the potential effects of prescription and non-prescription medications on the defendant’s ability to drive safely at the time of the accident.
For those not involved in accidents, “prevention is the best medicine”.
‘All sleep drugs have the potential to cause this, so health professionals should prescribe – and patients should take – the lowest dose that is capable of preventing insomnia,’ said Dr. Ellis Unger, a director in FDA’s Office of Drug Evaluation. If you must take sleep medications, make sure your dose is reduced to the new lower levels to ensure you can drive safely the next day. Take as low a dose as possible, and make sure you do not drive too soon.
Paul Mitchell, Q.C.is a BC personal injury lawyer who has extensive experience with severe injury claims, including brain injury claims, spinal injury claims, death claims, ICBC claims, medical malpractice claims, and other catastrophic injury claims. He acts for injured clients all over BC and Alberta, and will not act for ICBC or any other insurance company.
For more information on this article, or for a confidential discussion of your personal injury claim, contact Paul Mitchell, Q.C. at 250-869-1115 (direct line), or send him a confidential email at [email protected]
