The driver was weaving her car across lanes. She eventually veered off the side of the road and hit a child on a bicycle.
When the police arrived, they suspected she had been drinking. Not only had her driving been erratic, but she could barely communicate and had a hard time walking. They were puzzled, however, by the Breathalyzer test that came back negative.
At police headquarters she nearly fell off the chair. The police concluded that she was impaired not by alcohol but by the prescription anti-anxiety medicine she had been taking.
Millions of people drive under the influence of prescription drugs. There is no instant test that can tell if a medicine has made a driver unsafe. Certain computer programs can assess a driver’s ability to navigate (Journal of Studies on Alcohol and Drugs, March, 2009). Unfortunately, few police departments are equipped to administer and interpret such tests.
Physicians may not always tell patients not to drive while taking certain medications. More than 100 million prescriptions are dispensed annually for anti-anxiety agents like alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium) and lorazepam (Ativan).
They may carry a warning such as, “Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery.”
It’s not just sedatives that impact driving skills. A medication for fibromyalgia called Lyrica is widely advertised on television. The announcer cautions viewers, “Don’t drive or use machinery until you know how Lyrica affects you.”
The trouble is that people are not good at assessing how prescription medications affect their driving ability. Ask anyone who has had several beers if he is safe to drive and the answer might well be “sure.” Sophisticated tests of reaction time and judgment could tell a different story.
Drug company warnings are not clear enough. The prescribing information for the stop-smoking drug Chantix, for example, warns:
“There have been postmarketing reports of traffic accidents, near-miss incidents in traffic, or other accidental injuries in patients taking CHANTIX. In some cases, the patients reported somnolence, dizziness, loss of consciousness or difficulty concentrating that resulted in impairment…in driving or operating machinery. Advise patients to use caution driving or operating machinery or engaging in other potentially hazardous activities until they know how CHANTIX may affect them.”
Very few people would be willing to take a drug that precludes driving, but Chantix is not the only problem.
Medications like Requip and Mirapex are prescribed for restless leg syndrome (RLS). Patients taking these drugs have fallen asleep while driving and ended up in accidents. Some had no warning signs of drowsiness and felt alert immediately before the event.
Even over-the-counter allergy medicines can be dangerous. Diphenhydramine (AllerMax, Benadryl) was found to have “a greater impact on driving than alcohol did” (Annals of Internal Medicine, March 7, 2000).
There are hundreds of drugs that can make drivers a menace on the roads. Doctors and pharmacists should tell patients “DO NOT DRIVE” when taking these medicines. Inconvenient, yes. Life-saving, quite possibly.

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  1. Carol D.

    Interesting post. I’d have to agree that nobody can tell whether or not the medication will impair your senses when you take it. I think it’s because medications have different effect from person to person. Still, I’m wondering. Is there really not a way to know?

  2. RMD

    Many knowledgeable people in the medical and pharmaceutical fields understandably question some of the FDA issued warnings. It appears sometimes that they use a “blanket” approach hoping to hit a success and avoid a disaster as they did with Thalidomide many years ago.
    One decision which has caused controversy within the medical and pharmaceutical communities was the FDA’s pressure on the drug companies to withdraw the very effective arthritis drugs Vioxx and Bextra. These COX-2 inhibitors effectively relieved severe arthritic pain in millions of patients with little or none of the side effects of normal NSAIDS, such as stomach upset and bleeding, among others.
    Clinical trials for Vioxx such as the VIGOR and Kaiser Permanente trials concluded that a percentage of people taking these drugs over a period of 18 months or more, developed cardiac and cardiac related problems. It should be noted that the VIGOR clinical trial was conducted on over 8,000 patients with Rheumatoid Arthritis and the dosage for Rheumatoid Arthritis was at least double the standard dosage of Vioxx for Osteoarthritis patients and that there was no placebo involved because of the severe pain nature of the disease, so Blind test patients were taking a different drug.
    The Kaiser Permanente trials, compared Vioxx to Celebrex and was taken from patients in a 1.4 million patient database. As far as I can find neither study gave the exact percentage of patients that developed cardiac and cardiac related problems from Vioxx. At this time it should be mentioned that Vioxx was used by over 80,000,000 people worldwide. In response to the FDA warnings many doctors refused to prescribe these drugs for fear of litigation and thus many patients with no history of cardiac problems who could have benefited from these drugs were forced to use older much less effective drugs and OTC NSAIDS, to help alleviate their arthritis pain.
    This is not merely anecdotal because the above incident happened to me, I had been prescribed Vioxx at the lowest effective dosage for arthritic pain and it had been very effective. A few months later when I asked my Orthopedic surgeon for a new Vioxx prescription he refused to issue it and told me to use Tylenol. His reason was that he was not prepared to face unnecessary lawsuits. Tylenol comes with it’s own problems; long term use, large dosages or use with alcohol can cause permanent liver damage.
    I have also spoken to a number of physicians who feel that the benefits that Vioxx and Bextra offered to severely handicapped arthritis patients far outweighed their risks. It should be noted here that Celebrex the remaining COX-2 inhibitor is considered by some doctors and by many former Vioxx and Bextra users including myself, to be less effective at relieving the symptoms and pain of arthritis than Vioxx and Bextra were.
    The FDA is a necessary watch dog organization who normally does an admirable job, but sometimes their decisions regarding warnings for prescription drugs are not as clear to those who look at the details as they should be.

  3. Greg Pharmacy Student

    Thank you again. I apologize for not putting my comments into proper perspective.
    Perspective is the crux of many posts I read. One does not typically post their favorable experiences with medications.
    Perspective would be a great addition to medication labeling.
    I’d like to see medications labeled with the number of people that need to treated to show benefit and likewise the number needed to harm due to side-effects.
    It is sometimes difficult to determine as a regular consumer or even a pharmacist if a positive outcome is likely or just a shot in the dark. Conversely it is difficult to determine if a side-effect is one that happens to nearly everyone or just 1 in 1000, and if that side-effect is severe or usually tolerable.

  4. RMD

    Thank for the clarification regarding Dalmane and Ambien warnings. I agree with your statement “I would encourage everyone to read the prescribing information of all the medications you are taking to get a better idea of the benefits you should expect and the risks that you may be exposed to.”
    As I have stated, I am only in favor of prescription drugs like Ambien when other more benign methods have not proven successful.
    The issue I take is with the cavalier term “Sleep-Driving”. It implies if you take Ambien at the recommended dosage and then sleep for 8 hours or more, you may all of a sudden fall asleep at the wheel in the daytime during your normally alert waking hours. I suspect many more people encounter Sleep Deprived Driving than Sleep-Driving. I have not seen any conclusive clinical trials or studies that indicate Sleep-Driving is a valid medical term. The FDA requested that Pharmaceutical companies issue this warning in 2007 shortly after a study issued by the Toxicology Section of the Wisconsin State Laboratory of Hygiene came out in March 2006. The study was presented at the American Academy of Forensic Sciences, Feb 23, 2006
    This study was conducted on Six patients. Quoting the report. A standard 10 mg dose of Ambien, she said, produces serum levels of 121 ng/mL (58 ng/mL to 272 ng/mL). If a patient goes to sleep, eight hours later blood levels would be zero or close”. “However, in the six cases reported at the meeting, levels were as high as 1,000 ng/mL, and in one case 4,400 ng/mL. One patient with an out-of-date Ambien prescription was buying her drugs on-line.” “The researcher said that the pattern involved taking the drug and not going to bed, or taking more than the recommended dose. Some got up and drove in the middle of the night. Others took the drug with the idea of driving home and then going to sleep. “”They haven’t slept it out and the drug was still in their system,” she said. In addition, Ambien was sometimes taken along with other antidepressants, although alcohol was not involved in these six cases”.
    This is hardly conclusive evidence of Sleep-Driving. All these patients were forcing themselves to stay awake under the influence of a Sleeping medication. In other words they were either forcing themselves to stay awake or they exceeded the dosage. Almost any drug would cause ill effects under these circumstances. This is analogous to a hypertensive eating a meal containing 4000 mg salt and then doubling or tripling his Doctor prescribed dosage Blood Pressure medication in an attempt to manage the salt overload. A recipe for disaster. As they say in IT, the results may be unpredictable.
    The 2007 FDA statement implies that there were other conclusive studies. There may have been, but I can’t find any prior to the FDA’s warning. Quoting Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research, “after reviewing the available post-marketing adverse event information for these products, the FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks.” In addition, Russell Katz, M.D., director of the FDA’s division of neurology products is quoted as “He repeatedly emphasized that the allergic reactions, including anaphylaxis and angioedema, and the complex sleep-related behaviors,”are rare by any definition” and he said the FDA has not received any reports of death associated with either side effect.” Dr. Katz said that the FDA believes that the risk of complex sleep-related behavior might be increased when the consumers exceed the recommended dose or when the drugs are combined with alcohol or other drugs that depress the nervous system. Dr. Katz said that adverse drug event reports have not been received for all drugs in the sedative-hypnotic class but “we believe that the risk extends to all drugs in this class.” There were 13 drugs in all. He said the FDA’s action was triggered by two events — reports of “angioedema in the wake of the most recently approved hypnotic (ramelteon [Roserem])” and recently published studies of sleep driving and other complex sleep-related behavior.
    Lacking any other evidence of published studies in 2007, the only thing one can assume is that Dr. Katz is referring to the above mentioned Wisconsin State Laboratory Study which I feel is hardly conclusive. I will leave it up to you to decide that.
    What I fear is that the term Sleep-Driving will be bandied about by the public and will scare off the people who most need these drugs, those for whom all other conventional methods have failed. After all what sane person would not be afraid of being severely injured while sleeping and driving or worse dying in their sleep while driving.
    I am still not convinced that Sleep-Driving is either a valid term or a valid concern with patients who take Ambien at the regular Doctor prescribed dosage, in a responsible fashion, for a limited amount of dosages and at home 30 minutes before bed. As always if you have to take any prescription drug take it for a few days as a trial to see that you have no adverse reactions. Common Sense should be the rule.

  5. Greg Pharmacy Student

    Thank you for the detailed response. Great advice. Medications are often the last thing we should try.
    The prescribing information is for Ambien. Please see the manufacturers site:
    While sleep driving is also listed in the prescribing information for Dalmane ( ) it might only be due to a blanket warning mandated by the FDA; not case reports from those on Dalmane.
    Although it maybe difficult, I would encourage everyone to read the prescribing information of all the medications you are taking to get a better idea of the benefits you should expect and the risks that you may be exposed to.

  6. Cindy B

    I guess some people can be quite impaired and get behind the wheel, thinking they’re driving just fine…. but I CAN’T IMAGINE how this would be possible! Surely when you can’t talk clearly, can’t concentrate, can’t walk a straight line, head spinning, etc., you WOULD BE AWARE OF THAT! I know when I have more than one beer in a single sitting, I can really feel it and if I have to drive, I’m going like 15 mph with white knuckles…

  7. Rmd

    I think you mean Dalmane, not Delmane. I’m not sure in your “The prescribing information lists:” you are referring to Dalmane or Ambien. If your speaking of Dalmane the PDR doesn’t support “sleep driving” or hallucinations as a normal side effect. Of course if Dalmane is taken with alcohol, which should never be done when taking any prescription drug, the results can be serious and may be extreme.
    If you are speaking of Ambien, I can speak to that because I have taken it. Unfortunately a lot of the information we have gotten on it is anecdotal and becomes “he says she says” without any scientific basis. Did the person take it during the daytime? Did they take it while drinking alcohol? Did they take it with other medications or drugs? The list goes on of unsubstantiated claims. Having said that, there is no doubt that there is a long list of known side effects for Ambien that may include:
    Anterograde amnesia
    Hallucinations, through all physical senses, of varying intensity
    Altered thought patterns
    Ataxia or poor motor coordination, difficulty maintaining balance
    Euphoria and/or dysphoria
    Increased appetite
    Decreased libido
    Impaired judgment and reasoning
    Uninhibited extroversion in social or interpersonal settings
    Increased impulsivity
    When stopped, rebound insomnia may occur
    Headaches in some people
    Short term memory loss
    This is why it is important to use a drug for the use it is intended. The patient should understand the contra-indications, drug interactions and side effects. Ambien is a sleeping aid and as such should be taken 30 minutes before bedtime as prescribed by a doctor. It should never be taken with alcohol, during the daytime or when driving or operating machinery. As always there should be a time trial of a few nights so the patient understands the effects that Ambien will have on them when they’re not sleeping; and on the advice of a doctor, should be discontinued if any of the known side effects occur. I say on the advice of a doctor because many of the side effects may lie dormant or may already be present in a patient who is not sleeping well due to other medical problems.
    In addition, Ambien should not be taken for prolonged periods of time unless under the advice of a Doctor, because like any drug when taken over an extended period of time, its dosage effectiveness decreases and higher dosages are required to get the same effect.
    As far as Ambien causing “sleep driving”, I believe this is anecdotal and has never been scientifically proven. It is probably confused with the normal boredom and tired feeling that results from driving long distances without a break, particularly at night. Regarding “sleep walking” there are many factors besides Ambien that can cause that. Many sleep walkers have never taken a sleeping pill. As always your first line of defense against drug side effects is Common Sense. If you are not sleeping properly a sleeping pill such as Ambien should be used only after proper exercise, eating properly, meditation and relaxation have failed to help you. If you are not sleeping well, a Prescription drug like Ambien should be the last thing you try, not the first.

  8. Greg Pharmacy Student

    I suppose I would have mentioned other possibly causes of passing out. Thanks for introducing many other possible explanations. In talking with my friend it turns out it was Dalmane (flurazepam) NOT Ambien.
    Is there a page on Ambien in here? It definatley has many side-effects that are not well know. I read about sleep eating not long ago.
    The prescribing information lists:
    – Abnormal thinking, behavioral changes, complex behaviors: May include “sleep-driving” and hallucinations. Immediately evaluate any new onset behavioral changes (5.3)
    – Depression: Worsening of depression or, suicidal thinking may occur. Prescribe the least amount feasible to avoid intentional overdose

  9. RMD

    People can blackout for a variety of reasons. Blood pressure, severe allergies, hardening of the arteries, loss of blood (from excessive use of aspirin or other NSAIDS), minor strokes and drugs or drug interactions. The fact that she took one Ambien and later in the day blacked out is odd. Normally if a drug is going to affect you that severely it does so within one hour after taking it. If she had felt sleepy or light headed, that could point to the Ambien, but a complete blackout may indicate a more serious problem either not related to Ambien or exacerbated by it.

  10. Greg Pharmacy Student

    I heard about a woman who “luckily” hit a utility pole just before she almost drove in to the river. She was on Ambien and just had a blackout in the middle of the day driving.

  11. RMD

    While I agree that the above mentioned drugs should contain a warning and many do, it’s a bit like telling a person not to swim too far out if they’re not a good swimmer. People have to use common sense.
    Some people are affected much more by these drugs than others. A person can take 1 5mg Xanax and function calmly with no motor impairment. Another can take half that amount and get sleepy. A doctor can only advise you, they can not tell you exactly how you will react to a drug until you take the drug.
    As such the prudent approach is to not drive a car or operate machinery until you have had a trial run with any suspected drug (taking it a few times) and know how you will react. We have to be responsible for our own actions and not make Doctors and Pharmacists responsible for our irresponsible actions. I think it will be nearly impossible to get most people not to drive while taking these drugs unless they want to or absolutely have to.
    I suspect that if a Doctor or a Pharmacist insists that a patient not Drive while on a given drug, many patients would look for another drug, another Doctor or another Pharmacist. We don’t seem to be able to stop people from smoking and second hand smoke kills many people each year. We don’t seem to be able to stop people from drinking alcohol and driving and the statistics are undeniable that this causes many deaths each year.
    I don’t think we will be too successful stopping people from taking prescription drugs and driving. Many people on these prescription drugs must drive as part of their jobs or to get to and from work. It’s laudable to want to require people not to drive while on these prescription drugs, but I’m not sure it is practical. It’s sort of like world peace, it’s a noble ambition but almost impossible to achieve.
    The only way that I can think of that people may not drive while on these prescription drugs is in addition to issuing clear warnings on the drugs, make driving while taking these drugs a felony with very stiff penalties, but we do this now for alcohol with little success. This is definitely a conundrum, not easily solved. Human nature and habits are always the hardest things to change.

  12. Kris M.

    I totally agree that people shouldn’t be allowed to drive while on prescription meds. After I had my wisdom teeth removed, I was put on Vicodin, and I knew from the moment it started working that I was not going to be able to drive. I refused to come into work until I was off the med. If you can’t stay home from work while you’re on a prescription med, find someone who would be willing to drive you to and from work. That can also be a good motivation for you to get off the prescription med as soon as possible. Remember, these meds aren’t designed for you to use forever.

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