The FDA has requested that new warnings be placed on the labels of various prescription sleep medications. The warning includes the risk of “sleep-driving.” Yes, sleepdriving, just like sleep-walking and sleep-eating is one of the risks. Here is an ABC news story about the risks of driving while taking Ambien. It is estimated that 26 million prescriptions were written for the drug last year. People that have any quantity of alcohol and then take a sleep aid are at greater risk for this occurance. The people that this happens to are charged with DUI even thought they had no intent to drive and don’t even usually remember the driving or the encounter with police.
Sleep-driving
March 15th, 2007 Rob Leonard Posted in Driving under the Influence of Drugs, Health Issues No Comments »
Sleeping Driving: Ambien, Lunesta, etc.
March 15th, 2007 Allen Trapp Posted in Driving under the Influence of Drugs No Comments »
FDA Requests Label Change for All Sleep Disorder Drug Products
The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. “However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks.”
In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:
Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.
In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.
Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.
The medications that are the focus of the revised labeling include the following 13 products:
Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)
For more information on the sedative hypnotic products and sleep disorders, visit http://www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm;
www.fda.gov/womens/getthefacts/sleep.html and www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html.
How can you be under the influence of drugs when you aren’t?
January 16th, 2007 Allen Trapp Posted in Driving under the Influence of Drugs 2 Comments »
“Every state needs a law … defining, in essence, a crime divorced from impairment; … that says if you use an illicit drug and drive, you have broken the law. … We need to treat DUID as important [an offense] as murder, rape, and child molestation.” – John Bobo, Director, National Traffic Law Center. “Enforcement and Prosecution of Drugged Driving Laws,” speech given February 23, 2004.
– John Bobo, Director, National Traffic Law Center. “Enforcement and Prosecution of Drugged Driving Laws,” speech given February 23, 2004.There’s a new front in the “War on Drugs” and its name is DUID. DUID, short for “driving under the influence of drugs,” is the latest buzzword among politicians and police; however, in this case, words can be deceiving.
Though billed by their sponsors as a necessary tool to crack down on “drugged driving” offenses, the increasingly popular “zero tolerance” laws have nothing to do with promoting public safety or keeping dangerous drivers off the roadways. On the contrary, the goal is simply to punish those who have consumed a contraband substance - particularly marijuana - at some time in the past.
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Most states still have “effect based” laws that forbid the operation of a motor vehicle if a person is either “under the influence” or sometimes “incapable of driving safely” due to the use of a drug. Virtually nobody objects to such laws. However “per se” laws prohibit the operation of a motor vehicle if an individual has any amount of a drug or its metabolite in his/her system. This approach is based on convenience - not science. It is, in the words of one of its chief proponents, “divorced from impairment.”
In the case of marijuana, these laws are particularly troublesome. Marijuana’s primary metabolite, THC-COOH, is inactive (i.e., no intoxicating effects whatsoever), but is detectable in urine for days and weeks after use. Consequently, under a “zero tolerance” law someone who smoked a joint in Amsterdam on Monday could be arrested the following Friday in Detroit and charged with driving under the influence even though he or she is clearly no longer impaired.
This is the next great frontier for NHTSA, and they have plans to withhold Federal highway funds from states that don’t adopt draconian “zero tolerance” legislation. And don’t think it’s just marijuana. Your grandmother’s Valium is also in their cross-hairs.
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