Ambien Sleep Driving: The Problem

January 25th, 2012 Allen Trapp Posted in Driving under the Influence of Drugs, Health Issues No Comments »

     Zolpidem Tartrate, sold under the brand name Ambien, is a non-benzodiazepine sedative hypnotic. The non-benzodiazepines are a class of psychoactive drugs that have pharmacological characteristics similar to the benzodiazepines, with similar benefits, side effects, and risks, although they have dissimilar chemical structures. A sedative hypnotic is a drug that depresses the activity of the central nervous system and is used chiefly to induce sleep and to allay anxiety.

     Barbiturates, benzodiazepines, and other sedative-hypnotics have diverse chemical and pharmacologic properties that share the ability to depress the activity of all excitable tissue, especially the arousal center in the brainstem. Sedative-hypnotics are used in the treatment of insomnia, acute convulsive conditions, and anxiety states and to facilitate the induction of anesthesia. Although sedative-hypnotics are generally sleep inducing, they may also interfere with rapid eye movement (REM) sleep that is associated with dreaming. It has also been noted that when administered to patients with fever some of these drugs may act paradoxically and cause excitement rather than relaxation.

Sedative hypnotics may interfere with temperature regulation, depress oxygen consumption in various tissues, and produce nausea and skin rashes. In elderly patients they may cause dizziness, confusion, and ataxia. Drugs in this group have a high potential for abuse that may cause physical and psychological dependence. Treatment of dependence involves gradual reduction of the dosage because abrupt withdrawal frequently causes serious disorders, including convulsions. Buspirone and zolpidem are among the newer non-barbiturate non-benzodiazepine sedative hypnotics.

     Zolpidem is a benzodiazepine receptor agonist with high binding affinity for the GABA receptor. It was developed as a drug with a structure different from the benzodiazepines in order to provide it with an affinity for only a subset of the benzodiazepine receptors resulting in hypnotic properties without significant anti-convulsant, anti-anxiety, or muscle relaxant properties associated with the various benzodiazepines. Therefore, Zolpidem may be said to “compete” with the benzo’s for the attention of only some of the same receptors.

     Zolpidem has been available in this country since 1993, and for several years has also been available in a time release formula. It is available in both a five milligram and ten milligram tablet. The manufacturer recommends that it only be taken when a person has eight hours available for uninterrupted sleep. The peak concentration of the drug usually appears in the bloodstream between one and a half to two and a half hours. Therapeutic levels are reported as 29 to 113 ng/ml following a 5 mg. dose and 58 to 272 ng/ml following a 10 mg. dose according to the package insert.

     By around 2005 reports of parasomnias began surfacing. These are undesirable motor, verbal, or experiential events that occur during sleep. One of the more common was uncontrolled sleep eating. Raw eggs, uncooked rice, loaves of bread - they were all fair game. Cooking - and we are not talking about dishes that are particularly appetizing - was also reported, as well as sleep walking and sleep driving.

     Initially the manufacturer, Sanofi-Aventis, took the position that four percent of the population already suffered from somnambulism, and that while “events of sleepwalking have occurred during treatment with Ambien, these instances cannot be systemically linked to the product.”

     Finally, in March of 2007 there were two important developments. First, the Food and Drug Administration demanded that the makers of thirteen sedative hypnotic drugs include warnings about possible unusual behavior including sleep driving and recommended that the manufacturers conduct clinical studies to investigate the frequency with which sleep driving and other parasomnias occur in association with each product. Second, the manufacturers notified health care providers (i.e, the doctors prescribing the stuff) that the precautions were being revised to warn patients about the possibility of sleep driving and that such “complex behaviors” had been reported. Sanofi Aventis conceded that these events could occur in sedative hypnotic naive as well as sedative hypnotic experienced persons. Ambien (Zolpidem) was not the only drug affected. The others included Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal, and Sonata. While Ambien related sleep driving cases have been encountered by all DUI defense attorneys, cases involving the other drugs are rare. Nevertheless, these drugs are on the same list as Ambien, so if a defense is viable for Ambien, it should be viable for these other medications as well.

     The question remains why would someone who has taken Ambien get out of bed and eat unappetizing food, cook stranger things, drive their cars into telephone poles, and have no memory of the event? A possible explanation for zolpidem induced nocturnal behavior is that after a person is aroused from sleep, he or she will walk, drive, or eat, and subsequently not recall the event after returning to sleep because of the sedation-mediated amnesic properties of zolpidem. Another possibility is that an arousal occurred out of deep sleep with the parasomnia occurring in this electroencephalographically verifiable stage of sleep. The author believes that at least in some cases the latter has been experienced, because the drivers’ interaction with police and other individuals was extremely incoherent, their behavior was “zombie-like”, and they stared blankly at the police as if looking through them.
Written by Allen Trapp who is board certified by the National College for DUI Defense and the author of Georgia DUI Survival Guide Visit Website

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Driving While under the Influence of Drugs

March 27th, 2011 Richard Blevins Posted in Driving under the Influence of Drugs, Field Sobriety Tests No Comments »

In Georgia you can be arrested and prosecuted for driving a motor vehicle under the influence of drugs.  Some law enforcement officers have completed the Advanced Roadside Impaired Driving Enforcement (A.R.I.D.E.) course and are trained to conduct additional tests to determine if someone should be arrested for operating a vehicle under the influence of drugs.  I just completed the course, the same one that law enforcement officer complete in their training.  I learned about the three additional tests that are used on the roadside to determine if someone is under the influence of a drug.  Drugs are broken down into seven categories:  CNS Depressants, CNS Stimulants, Hallucinogens, Dissociative Anesthetics, Narcotic Analgesics, Inhalants, and Cannabis.To test for a subject for operating a vehicle DUI-Drugs, the look at general indicators and place them into a matrix to determine what drug you are under the influence of.   They are required to administer the Horizontal Gaze Nystagmus (HGN), Vertical Gaze Nystagmus (VGN), Walk and Turn and One Leg Stand tests.  Next they perform three more evaluations:  Pupil Size Observation, Lack of Convergence and the Romberg Balance Test.  Written by Richard N. Blevins, visit my website.

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Government says Driving Under the Influence of Drugs is Up.

July 28th, 2009 Allen Trapp Posted in Driving under the Influence of Drugs, Current Events, Studies No Comments »

     Fewer Americans are driving drunk, but roughly one in six drivers on weekend nights is driving under the influence of drugs, according to a data released Monday by the National Highway Traffic Safety Administration survey.  In a survey conducted in 2007, 2.2 percent of drivers had a blood-alcohol content of 0.08 percent or higher, which would exceed the limit for driving while intoxicated in all 50 states and the District of Columbia, the agency said in a news release.

     The first such survey, conducted in 1973, found 7.5 percent of drivers above the 0.08 limit, the release said. Other surveys were conducted in 1986 and 1996.
“I’m pleased to see that our battle against drunk driving is succeeding,” Transportation Secretary Ray LaHood  said in the news release.  “However, alcohol still kills 13,000 people a year on our roads and we must continue to be vigilant in our efforts to prevent drunk driving.”

     The 2007 survey was the first to also check for drug use while driving. It found that 16.3 percent of nighttime weekend drivers tested positive for drugs, according to the statement.  What the NHTSA report does not explain is what percentage of these drivers was under the influence of drugs or even impaired to the slightest degree.  The drugs used most commonly by drivers were marijuana (8.6 percent), cocaine (3.9 percent) and over-the-counter and prescription drugs (3.9 percent), it said.  The last group would include such popular medications as Xanax, Lorcet, and Valium.  “This troubling data shows us, for the first time, the scope of drugged driving in America and reinforces the need to reduce drug abuse,” said Gil Kerlikowske, director of the Office of National Drug Control Policy.

     The survey involved setting up random sites across the country to question drivers who participated voluntarily and on condition of anonymity.  In total, almost 11,000 eligible drivers entered the survey sites, with 9,413 drivers agreeing to breath-alcohol measurements, 7,719 providing oral fluid samples and 3,276 nighttime drivers submitting blood samples, the news release said.

Written by Allen Trapp who is board certified by the National College for DUI Defense and the author of Georgia DUI Survival Guide Visit Website
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Urine Testing: The Basics

March 19th, 2009 Allen Trapp Posted in Driving under the Influence of Drugs, Urine Test No Comments »

     Urine samples are usually tested for drugs by using a screening test followed by gas chromatography-mass spectroscopy (GCMS).  The screening test is normally an enzymatic method of analysis that determines if the “signal strength” is at or above a cut-off level.  These tests employ reagents that interact with several different but related compounds (e.g., metabolites) and measure the total “signal strength” of all those compounds. 

     GCMS should be able to identify both the parent drug and any metabolite(s).  If a parent drug is identified, the metabolite should also be present.  For example, if a urine sample is positive for methamphetamine, it should also be positive for amphetamine. 

     In order for a test result to be reported as positive the amount of a compound should equal or exceed the cut-off level.  If the cut-off limit for the GCMS is not met, the result should be reported as negative.   In other words, sound science dictates that reports reading “lower than the lowest calibrator” should not be reported as positive.

     One final word about metabolites: Most metabolites are less psychoactive than the parent drug or are inactive, which means that they have no impact on the person.  If only an inactive metabolite such as carboxy THC is found in a urine sample, the metabolite did not affect driving. 

Written by Allen Trapp who is board certified by the National College for DUI Defense and the author of Georgia DUI Survival Guide Visit Website
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Combined Influence of Alcohol and Drugs

March 19th, 2009 Allen Trapp Posted in Driving under the Influence of Drugs, Blood Test, Chemical Test No Comments »

     We are seeing more arrests for DUI where the breath alcohol concentration is not consistent with the manifestations of impairment described in the arrest report or captured on video.  In some, but not all of these cases, the culprit is detected by a blood test, and that culprit is some drug other than alcohol that the client has consumed.  As more and more people take selective serotonin reuptake inhibitors (SSRI’s) such as Paxil and Prozac, we will see more and more of these cases.

     Alcohol and many drugs do not simply have an additive effect; they have a synergistic effect.  That is to say that the effects of the two substances are not merely added together but are essentially multiplied.  When even an adult dose of acetaminophen may produce impairment equivalent to a BAC of .05, it is not difficult to understand how prescription medications combined with alcohol can cause serious impairment. 

     One of the other commonly abused drugs is oxycodone.  It is the narcotic found in Percoset (with acetaminophen) and Percodan (with aspirin).  It is a synthetic opioid and like its natural cousins can cause addiction and then withdrawal symptoms. 

     When we represent an individual with these drugs in his or her system at the time of arrest, it is almost always necessary to retain a pharmacologist or toxicologist.  Otherwise, an employee of the state crime lab will be the only “expert” in the courtroom, and that employee’s testimony, if unrefuted, will seal the defendant’s fate. 

Written by Allen Trapp who is board certified by the National College for DUI Defense and the author of Georgia DUI Survival Guide Visit Website
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Sleeping Driving: Ambien, Lunesta, etc.

March 15th, 2007 Allen Trapp Posted in Driving under the Influence of Drugs No Comments »

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:

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.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.

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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.

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.

Written by Allen Trapp who is board certified by the National College for DUI Defense and the author of Georgia DUI Survival Guide Visit Website
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