Experts See Need for Further Study of Insomnia and Sleep Aids like Ambien

By Steven DiJoseph

Although there is no doubt that every drug has at least one side-effect, there is no way to ascertain just how many people are affected in an adverse way by any particular. To be sure, not every side-effect is life-threatening and many are relatively mild; however, since each person reacts differently to a given drug, there may be wide variances in the scope and severity of reactions.

Clinical tests are usually of limited value in this area for three reasons (at least):

· The test groups are too small to adequately represent all sub-groups such as specific ages (adults, children, adolescents, seniors, etc.), weights (a critical factor in dosage-determination), genetic profiles (family history, racial variances, etc.), medical history (pre-existing conditions, diseases, etc.), risk factors (smoking, diabetes, hypertension, cardiovascular problems, alcoholism, etc.), and possible drug interactions. In fact, most clinical trials eliminate many of the sub-groups in order to get the clearest picture of how a drug performs without such collateral influences.

· They are not long enough to demonstrate how a drug will perform over the treatment periods that are most likely to be encountered. Thus, drugs that are intended to be used for many years (or even decades) are often tested for less than a year before being approved.

· Post-approval testing, which is supposed to be done and is often a condition of approval, is practically never completed. In many cases it is never even started.

For these reasons, experts recognize that the public often becomes the guinea pigs upon which a drug is actually tested. As a result, it is not until widespread exposure to a drug that data is collected in sufficient quantity and scope to observe patterns of risk and adverse reactions.

Even then, however, it is estimated that only between 1% and 10% of the adverse reactions associated with any drug are ever conveyed to the manufacturer or the FDA. This makes the evaluation process take much longer than desired and may even prevent the meaningful analysis of a drug’s side-effects for years.

Over the past few years, a number of drugs have been linked to various side effects that are not commonly associated with medications. Even when doctors and patients realized that problems existed, they failed to connect them to the drugs they were taking until significant numbers of people suffering from the same conditions came forward.

Some of the more peculiar side effects have been: (1) compulsive gambling and other unhealthy addictions linked to Mirapex and Requip, which are used to treat Parkinson’s disease and Restless Leg Syndrome; (2) “rebound congestion” (medicamentosa), where nasal decongestants (like Afrin and Neosynefrin) have caused chronic cases of the very same condition the drugs were designed to treat; (3) loss of color vision caused by ONTAK (denileukin diftitox), a drug used to treat persistent or recurrent cutaneous T-cell lymphoma; and (4) loss of the senses of smell and taste caused by Zicam, a zinc-based non-prescription cold remedy.

Over the past few months, another group of unusual side effects (regarded by experts variously as “bizarre,” “weird,” or “strange”) have become more than just coincidentally linked to the blockbuster sleep medication, Ambien (zolbidem). When researchers took a closer look, they found that the problems had been occurring for quite some time without the association having been made.

Toxicology labs in a number of states have identified Ambien to be in the “top 10” drugs found in the blood of “impaired drivers” involved in dozens of accidents (usually running into stationary objects) or erratic driving while in “zombie-like” trances.

In addition, Ambien users have been found to have developed habitual behavior now referred to as “Ambien sleepwalking” in which people find themselves in a virtual “Twilight Zone” where they engage in various forms of binge eating.

This may include cooking sophisticated meals (with the risk of starting fires), eating food the person normally dislikes, or savagely ripping open and devouring entire packages or boxes of foods like peanut butter, margarine, hamburger rolls, or ice cream while asleep.

These people have no recollection of the behavior even though they have experienced significant weight gains or other problems (like beds full of food and kitchens left in a mess).

Some Ambien users have even done things while asleep that they were incapable of doing while awake, such as walking around in a body cast that confined the person to a wheel chair; shoplifting, or placing themselves in sexually awkward situations where they either engaged in acts they would not normally perform or became victims of sexual assaults.

The data from a small case study of the unusual effects of the drug on six drivers has also caused quite a stir among healthcare professionals and people who use the drug to help them sleep.

Laura Liddicoat, supervisor of the toxicology section of the Wisconsin State Laboratory of Hygiene in Madison, presented her findings at the American Academy of Forensic Sciences meeting.

According to Liddicoat, drivers under the influence of high doses of Ambien have crashed their cars and then had absolutely no memory of the accident. The sleeping pill apparently continued to impair drivers even after they have attempted to sleep off the effects.

The pattern considered in the study involved taking the drug and not sleeping, or taking more than the recommended dose. Some drivers, for example, got up and drove in the middle of the night, while others, who planned to go to sleep as soon as they got home, took the drug before driving.

It appears that in these situations, the patients haven’t slept all of the drug out of their system and some had also taken Ambien along with other antidepressants. Alcohol was not involved in any of the six cases reviewed.

According to Liddicoat, a standard 10 mg dose of Ambien produces serum levels of 121 ng/mL (58 ng/mL to 272 ng/mL). After eight hours of sleep, that level should be close to zero. In the six reported cases, however, levels were as high as 1,000 ng/mL, and in one case 4,400 ng/mL.

The results of having high amounts of the sleeping pill in their bodies have produced a variety of strange effects on drivers, including: driving on the wrong side of the road; crashing into stationary objects; and suffering confusion, imbalance, and memory loss. Some patients had no idea why they were in the hospital or were being arrested.

Liddicoat described extreme mental and physical effects when driving within five hours of taking the drug. “Drugged driving cases have been steadily increasing over the last five years, and Ambien cases have mirrored this trend…”

Tests on subjects the morning after taking a single dose 10 mg (5 mg in the elderly) right before bedtime revealed no significant residual effects on memory or actual driving. In large doses, and without ample sleep, however, Ambien patients displayed confusion or loss of memory.

Sanofi-Aventis, the makers of Ambien, instructs patients to take the drug right before going to bed and only when they can devote a full eight hours to sleep. The company also cautions against operating heavy machinery or driving.

According to the New York Times, Sanofi-Aventis maintains that “the drug’s record after 13 years of use in this country shows it is safe when taken as directed.” The company has provided the FDA with reports of people driving while sleep walking due to residual effects of the drug.

The six examples of impaired drivers Liddicoat presented are: (1) Driver taking 670 ng/mL while driving, reported to be “very out of it;” (2) Driver taking 500 ng/mL plus Celexa (citalopram) crashed into a parked car, bizarre behavior, couldn’t follow simple instructions; (3) Driver taking 820 ng/nL, poor comprehension, nearly fell over; (4) Driver taking 190 ng/mL plus other antidepressants driving southbound in northbound lane; (5) Driver taking 1,000 ng/mL plus Zoloft (sertraline) crashed into a truck; got drug online and continued to increase doses; (6) Driver taking 4,400 ng/mL drove on rim of flat tire, hit mailboxes, very confused.

It seems, however, that as medical experts, law enforcement agencies, and individual patients have started to compare notes, the strange side effects associated with Ambien are being found even in situations where the drug was not abused or taken in excessive dosages.

A federal class action has been filed in the United States District Court for the Southern District of New York to try to do something about all of this by seeking increased warnings to consumers and doctors about the possible side effect of risky or unwanted behavior while asleep.

The problem with these Ambien-related trances, however, is that they are not simply humorous. A growing number of them are (or have been without proper attribution until now) causing people (the user or third-parties) to suffer serious or potentially life-threatening injuries.

Reports of falling down stairs, walking (or driving) into stationary objects, being burned by hot ovens or stoves (that may also be left on all night after the person returns to bed), or being sexually assaulted are beginning to surface.

Law firms are being approached in steadily increasing numbers by Ambien users who are claiming that they have been injured in unusual occurrences that they are now associating with their use of the sleep medication.

As a result, Sanofi-Aventis (Sanofi-Synthelabo of France and Sanofi-Synthelabo Inc. of the U.S.) is likely to see more than simply a class action seeking to require it to include enhanced warnings on Ambien’s label.

Personal injury claims are now being investigated and reviewed by pharmaceutical litigation experts around the country and there is little doubt that many of these claims will evolve into lawsuits seeking monetary damages from Ambien’s manufacturer, which, until now, has seen annual sales in the $2 billion-plus range from over 26 million prescriptions.

Medical experts, including those familiar with sleep disorders (specifically insomnia), and the National Institutes of Health (NIH) are concerned about a number of issues. First, and foremost, is the fact that so many people are now being treated for chronic sleep disorders (over 50 million), according to the Institutes of Medicine. Annual spending on sleep medications is approaching $3 billion.

Other concerns are: (1) the misuse of drugs that are not intended to treat insomnia, such as antihistamines and antidepressants; (2) the lack of longitudinal (long-term) testing of sleep aids that some patients take for years even though they are recommended for short-term use only; and (3) the link between insomnia drugs like Ambien and the adverse events being attributed to them.

Consumer advocates like Dr. Sidney Wolfe (Public Citizen) see the medications as marginally useful and simply not worth the risks.

Thus, the NIH and sleep experts are advocating additional research into the cause of the epidemic-like increase in sleep disorders (especially insomnia) and the safety and side-effects of the various drug therapies used as treatments for sleeplessness.

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