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November 5, 2004

Tranquilizers (minor tranquilizers or antianxiety pills) and sleeping pills are discussed together because the most commonly used drugs in both classes belong to the same family of chemicals, called benzodiazepines. Many of the benzodiazepines, along with another sleeping pill, zolpidem (AMBIEN), were among the 200 most dispensed drugs in community pharmacies in 2002. Although Zolpidem is not a benzodiazepine, it has many of the same effects, including the potential to cause drug-induced...

Tranquilizers (minor tranquilizers or antianxiety pills) and sleeping pills are discussed together because the most commonly used drugs in both classes belong to the same family of chemicals, called benzodiazepines. Many of the benzodiazepines, along with another sleeping pill, zolpidem (AMBIEN), were among the 200 most dispensed drugs in community pharmacies in 2002. Although Zolpidem is not a benzodiazepine, it has many of the same effects, including the potential to cause drug-induced dependence and addiction.

Older adults have a much more difficult time eliminating benzodiazepines and similar drugs from their bloodstreams and these drugs can thus accumulate in their bodies. Also, older adults are more sensitive to the effects of many of these drugs than are younger adults. For older adults the risk of serious adverse drug effects is significantly increased. Serious adverse effects may include: unsteady gait, dizziness, falling (causing an increased risk of hip fractures), increased risk of an auto accident, drug-induced or drug-worsened impairment of thinking, memory loss, and addiction.

Despite these significantly increased risks, sleeping pills and minor tranquilizers are prescribed much more often for older adults than they are for younger adults, for much longer periods of time, and usually not at the reduced dose that could decrease the risks. Commonly used sleeping pills or tranquilizers, in addition to the benzodiazepines, include the following:

Non-Benzodiazepine Sleeping Pills and Tranquilizers

  • Buspirone (BUSPAR)
  • Barbiturates: According to the World Health Organization, these drugs should not be used by older adults for anxiety or sleep disorders.[1] (Phenobarbital can be used for the treatment of convulsions or seizures.)
  • Meprobamate (MILTOWN, EQUANIL)
  • Hydroxyzine (ATARAX, VISTARIL) as a sleeping pill or tranquilizer
  • Glutethimide (DORIDEN)
  • Chloral hydrate (NOCTEC)
  • Methyprylon (NOLUDAR)
  • Diphenhydramine (BENADRYL, SOMINEX FORMULA)

How Often Are These Drugs Prescribed?

One study found that older adults, 65 or older, in good health were prescribed tranquilizers such as diazepam (VALIUM), sleeping pills, and sedatives 7.5 times more often than healthy people aged 18 to 64.[2]

In the United States, there was a large shift, between 1985 and 1997, in the use of psychotherapy to treat office visits in which patients had an anxiety disorder. In 1985, psychotherapy was offered, alone or in combination with prescription drugs, in 23% of office visits for anxiety disorders, but the use of psychotherapy dropped precipitously to only 5% of visits in 1997. This shift from psychotherapy to drug therapy was also accompanied by an extraordinary increase in the use of antidepressants in such visits. In 1985, in only 15.5% of visits by patients with anxiety disorders was an antidepressant prescribed, but by 1997, in 40.4% of such visits an antidepressant was prescribed, the increase mainly accounted for by the increased use of selective serotonin reuptake inhibitor (SSRI) antidepressants such as fluoxetine (PROZAC) and paroxetine (PAXIL).[3]

A survey in the United States of almost 6,000 people between the ages of 15 and 54 found that primary care physicians were much more likely than psychiatrists to prescribe antidepressants, tranquilizers, or sleeping pills for patients who did not have mood or anxiety disorders. Primary care doctors prescribed antidepressants to 22% of people, tranquilizers to 17% of people, and sleeping pills to 13% of people without mood or anxiety disorders. The author concluded that “primary care physicians are less selective in their use of psychoactive medicines, perhaps because of lower sensitivity and specificity of diagnoses in primary care settings.”[4]

How Much Use Is Justified in View of the Significant Risks?

Minor Tranquilizers

Although minor tranquilizers are prescribed more often and for longer periods of time for older adults than for younger adults, studies have shown that, if anything, older adults have lower levels of “psychic distress” or serious “life crisis” than younger adults. Worse yet, since older adults usually take more prescription drugs for the direct treatment of physical diseases, the prescribing of tranquilizers is all the more dangerous because of possibly dangerous interactions.

In 1979, Roche, then the maker of Valium, Librium, and Dalmane, sent doctors brochures encouraging the use of Valium for older adults as “an important component of treatment programs for the relief of excessive geriatric anxiety and psychic tension.”[5]

Faced with falling sales of Valium, the early 1980s saw Roche (and other drug makers) aggressively pursue the older adult market share. A series of handsomely illustrated brochures entitled Roche Seminars on Aging were mailed to doctors in 1982. Roche recommended Valium as appropriate for the elderly with “limited” coping skills, facing “not only the constraints brought about by their own reduced capabilities, but also those imposed by the social structure and environment.”

In a discussion about the use of tranquilizers and sleeping pills by older adults, World Health Organization (WHO) experts said the following: “Anxiety is a normal response to stress and only when it is severe and disabling should it lead to drug treatment. Long-term treatment...is rarely effective and should be avoided....Short-term use (less than two weeks) will minimize the risk of dependence.”

They concluded by saying that “discussion of the problems of sleeplessness and anxiety and the drawbacks of drug therapy will often help the patient to come to terms with his or her problem without the need to resort to drugs.”[1]

Two studies on alternatives to the use of minor tranquilizers further highlight how much of the present use is unnecessary. Ninety patients, suffering mainly from anxiety, were randomly divided into two groups when they went to see their family doctors. The first group was given the usual dose of one of the benzodiazepine tranquilizers. The other group was given a small dose of a much safer treatment consisting solely of “listening, explanation, advice, and reassurance.” The two treatments were equally effective in relieving the anxiety, but those receiving the informal counseling were more satisfied with their treatment than those given minor tranquilizers.[6]

In a second study, patients with anxiety were given either one of three different tranquilizers or a placebo (sugar pill). At the end of a month, with weekly evaluations of their anxiety levels being made by the patients themselves and by professional evaluators, the results showed “all four treatments to be efficacious in their therapeutic effects on relieving anxiety.”[7] That is, placebos worked as well as tranquilizers.

Sleeping Pills

The increases in the use of these drugs by older adults, noted above, flies strongly in the face of the conclusions and recommendations of an exhaustive study by the National Academy of Sciences’ Institute of Medicine in 1979.[8],[9]

Speaking generally about the use of sleeping pills, the study concluded that: “hypnotics (sleeping medications) should have only a limited place in contemporary medical practice: it is difficult to justify much of the current prescribing of sleeping medication. As a standard of prudent ambulatory medical care, the committee favors the prescription of only very limited numbers of sleeping pills for use for a few nights at a time....Hypnotic drugs should be selected carefully and prescribed cautiously, if at all, for patients...who are old.”

Commenting specifically on sleeping pill use by older adults, the authors said: “Of particular concern is the regular and prolonged use by this group of sleep-inducing medications that are of dubious value, and that add new hazards to their already complicated drug intake regimens.”

Although older people tend to complain more than younger people about sleeping problems, the study found that the time it takes to fall asleep does not increase with age, and that the total sleep time decreases very little, if at all. Older people who go to bed early and take catnaps during the daytime often do have sleeping problems. But, the study concluded, “it is this pattern of daytime sleep that must be changed instead of treating the night time insomnia that results from it.”

According to Dr. Marshall Folstein, a Johns Hopkins psychiatrist and expert in Alzheimer’s disease, “it is extraordinarily rare to find an older person who actually requires them [sleeping pills].”[10]

What Are the Main Risks of Sleeping Pills and Tranquilizers?

Drug-induced dependence, daytime sedation, confusion, memory loss, increased risk of an auto accident, poor coordination resulting in falls and hip fractures, impaired learning ability, slurred speech, and even death are adverse effects of these drugs. They are more likely to occur when these drugs are taken in combination with alcohol or other depressant drugs. They can happen to anyone at any age.

Older adults, however, cannot clear many of these drugs from their systems as rapidly as younger people can. They are also more sensitive to the drugs’ adverse effects. Despite this evidence, older adults (1) are more likely to be given a prescription for tranquilizers or sleeping pills, (2) are not usually given the reduced dose that would at least diminish the odds of serious adverse effects, and (3) are prescribed these drugs for longer periods of time than are younger people. Therefore, it is not surprising that older adults are at much greater risk of suffering from adverse effects, and, when they occur, they are much more serious.

One of the biggest impediments to discovering and eliminating these drug-induced problems is their frequent attribution to the aging process instead of to the drugs. The onset of impaired intelligence with memory loss, confusion, or impaired learning, or the onset of loss of coordination in a younger person will more likely prompt an inquiry leading to the drug as culprit. But the same symptoms in an older person, especially if they develop more slowly, are often dismissed with a familiar remark, “Well, he (or she) is just growing old, what do you expect?” This lack of suspicion allows the drug to keep doing damage because the doctor keeps up the prescription.

Hip Fractures

A study of 1,021 older adults with hip fractures found that 14% of these life-threatening injuries are attributable to the use of mind-affecting drugs, including sleeping pills and minor tranquilizers, antipsychotics, and antidepressants.[11]

There are approximately 227,000 hip fractures each year in the United States, virtually all in older adults.[12] Since the above study found that 14% of hip fractures are drug-induced, this means that if the results of the study are projected nationally, approximately 32,000 hip fractures a year in older adults are caused by the use of mind-affecting drugs. Of these, about 30%, or almost 10,000 hip fractures a year, are caused by sleeping pills and minor tranquilizers, particularly the long-acting drugs such as Valium, Librium, and Dalmane.

In a random sample of more than 4,000 people aged 20–89 followed for 12 years, 8.2% had suffered falls sufficiently serious as to cause hospitalization or death. People who had had one such injurious fall were 3.4 times more likely to have been daily users of sleeping pills and were 2.2 times more likely to have sometimes used these medicines. Even more striking, those people who had suffered two or more injurious falls were 8.2 times more likely to be daily users of sleeping pills and 3.9 times more likely to be occasional users of sleeping pills. This confirms and better quantifies earlier studies clearly linking the use of sleeping pills with falls and serious injuries.[13]

Especially in older people, injurious falls cause hip fractures that frequently lead to an increased risk of death.

Automobile Crashes That Caused Injuries

A study involving 495 automobile crashes by older drivers in which an injury occurred found that a significant number of such crashes by older adults aged 65–84 were attributable to the use of benzodiazepine tranquilizers and cyclic antidepressants. The study was particularly impressive because its findings were strengthened by observing that the rate of crashes that caused injuries increased in the same group of people when they were using these drugs as opposed to when they were not using the drugs. The majority of the excess number of auto crashes were attributable to the benzodiazepines. The authors, stating that the study findings may be generalizable to the population at large, found that if the association is causal, out of the 217,000 crashes that cause injuries that occur each year among elderly drivers, at least 16,000 are attributable to psychoactive drug use (specifically benzodiazepines and tricyclic antidepressants).[14]

Drug-Induced or Drug-Worsened Senility (Decreased Mental Functioning)

Drug-induced impairment of thinking is one of the most reversible, or treatable, forms of dementia. It is a by-product of the increased use of drugs during the past few decades. Among the 33 million people 65 and over in the United States, approximately 5 out of every 100 have dementia, with an estimated 1 of these 5 due to “reversible” conditions such as treatable diseases (thyroid disease, for example) or adverse effects of drugs.[15]

A study of 308 older adults with significant intellectual impairment found that in 11.4% of these people the problem was caused or worsened by a drug.[16] This study, the first ever to systematically analyze this problem, revealed that after stopping the use of the dementia-causing drugs, all persons had long-term improvement of their mental function. The most common of drugs to cause the impair-of mental function was the sleeping pill/tranquilizer group. It accounted for 46% of the drug-induced or drug-worsened dementia.

The University of Washington researchers who did the study had two further observations:

1. “Most patients had used these drugs for years, and the side effect of cognitive (mental) impairment developed insidiously as a ‘late’ complication of a drug begun at an earlier age.”

2. “The improvement experienced by patients in this study was usually surprising to family and caregivers. The patients noted an improved sense of well-being and were better able to care for themselves.”

If these important findings are applied to all of the estimated 1.43 million Americans 65 and over who have dementia, there are 163,000 people whose mental impairment has either been entirely caused by or worsened by drugs. For approximately 75,000 older adults, their impaired mental functioning is caused by sleeping pills or minor tranquilizers.

Drug-Induced Dependence

Drug-induced dependence is often called addiction by drug companies and doctors who seek to shift blame to the patients who were prescribed a drug but were not told that the drug could cause physical dependence. The withdrawal from drug-induced dependence includes symptoms of sweating, nervousness, or when more severe, hallucinations or seizures that are often accompanied by psychological dependence.

The myth used to be that only people who were prone to addiction, as judged by a prior history of alcoholism or other drug problems, would possibly become addicted to benzodiazepine tranquilizers or sleeping pills. Even then they would have to use very large doses of these drugs for a long period of time before addiction could occur.

This attitude, intended to cover up a major national problem, was “pushed” by the president of Hoffman-la Roche, the world’s biggest benzodiazepine maker (Valium, Librium, and Dalmane). Testifying in 1979 before U.S. Senate hearings on the abuse of these drugs, Robert Clark said that “true addiction is probably exceedingly unusual and, when it occurs, is probably confined to those individuals with abuse-prone personalities who ingest very large amounts.”[17]

It was clear then and is now even clearer that a large fraction, probably the overwhelming majority, of people who use any of the benzodiazepines at the recommended dose for more than one or two months will become dependent.

Another study showed that a large proportion of people became dependent on these drugs and experienced an unpleasant withdrawal syndrome when they suddenly stopped taking the drug (as opposed to gradually tapering the dose to reduce, if not eliminate, the withdrawal symptoms). The only difference between addiction to the longer-acting drugs such as Valium and Dalmane, and the shorter-acting drugs such as Ativan and Serax, was the time, after the drug was suddenly stopped, that it took before withdrawal symptoms occurred. With the longer-acting drugs the day of worst symptoms was the tenth; for the shorter-acting drugs it was the first. Withdrawal symptoms included anxiety, headache, insomnia, tension, sweating, difficulty concentrating, tremor, fear, and fatigue.

The authors of the study concluded that “when withdrawal was abrupt, symptoms were more frequent and more severe than when a gradual tapering technique was used....there is little justification for abrupt withdrawal.”[18]

Serious Breathing Problems

Another serious adverse effect of the benzodiazepines is their effect on respiration. One effect of these drugs has to do with sleep apnea, a common condition in older adults in which, for varying periods of time while asleep, breathing stops. Dr. William Dement, an expert in sleep research, has found that older people with sleep apnea who use sleeping medications can stop breathing for much longer—dangerously longer—periods of time as a result of the respiration-suppressing effects of the drugs. He told a government task force on sleeping problems that people over 65 should not use Dalmane because of the risk of worsening sleep apnea.[19]

A second problem in this category affects people with severe lung disease. Anyone with severe lung disease should not use benzodiazepines because they decrease the urge to breathe, which can be life-threatening.[20] Asthmatics should also avoid benzodiazepine sleeping pills and tranquilizers.

Other Adverse Effects[21]

  • Frequent: drowsiness and lack of coordination that can affect walking or driving a car.
  • Occasional: confusion, forgetfulness, rebound insomnia (more difficulty sleeping when the drug wears off), or, especially with triazolam (HALCION), excitement instead of sedation.
  • Rare: low blood pressure, bone marrow toxicity, liver disease, allergies, and rage reactions.

Reducing the Risks from Sleeping Pills and Tranquilizers

The best way to reduce the risks of these powerful drugs is to avoid using them for most of the conditions for which they are now prescribed, especially in older adults.

Alternatives for Anxiety

According to noted British psychiatrist Dr. Malcolm Lader: “Until recently most anxious patients in the United Kingdom were treated with tranquilizers, usually a benzodiazepine. However, recognition that these drugs can cause dependence even at normal therapeutic dosages has led to a re-evaluation of drug therapy, and the value of non-pharmacologic treatments is increasingly being recognized.”[22]

Two British doctors use a nondrug alternative for the treatment of mild to moderate anxiety (and similar problems). They say that “the best treatment is likely to be brief counseling provided by the general practitioner or by another professional working in the practice. Such counseling need not be intensive or specially skilled. It should always include careful assessment of the causes of the patient’s distress. Once these have been identified, anxiety may often be reduced to tolerable levels by means of explanation, exploration of feelings, reassurance, and encouragement.”[6]

What else can be done? Talking to nonmedical people—a friend, a spouse, a relative, a member of the clergy, may help to identify causes of anxiety and potential solutions. Gathering the courage to talk about difficult concerns will generally be a better solution than taking pills. For some people, a specialized form of psychotherapy can treat anxiety. If indeed medication is needed, it is best to see a psychiatrist. Getting regular exercise can also help relieve anxiety.

In addition, the use of foods, beverages, and over-the-counter (nonprescription) or prescription drugs that have significant stimulant effects can also cause a chemically induced anxiety that can be remedied. (See the list of such substances below, under alternatives for sleeping problems.)

Alternatives for Sleeping Problems

Experts in sleep and aging have recently stated that:

  • Many old people have exaggerated expectations of what sleep should be like and they “spend too much time in bed chasing sleep.”
  • Many older people use sleep as an escape from boredom.
  • “It’s extraordinarily rare to find an old person who actually requires [sleeping pills].”[10]

If the cause of the sleeping problem is depression, the depression should be addressed rather than simply treating the symptom by prescribing sleeping medication. If the cause is a medical condition, with pain as one of the components, the pain has to be treated rather than using a sleeping pill to induce sleep despite the pain. In the case of senile brain disease, such as Alzheimer’s, the sleep disturbance will probably not respond to sleeping medications.[8]

Drugs can produce stimulating effects and a chemically induced anxiety, making sleep more difficult:

  • Over-the-counter (nonprescription) drugs: Sleeplessness can be caused by caffeine, found in Anacin and other drugs, the stimulants found in Actifed, Contac, Sudafed, and other decongestant products, and the ingredients in many asthma drugs.
  • Prescription drugs: Sleeping problems may be caused by asthma drugs containing theophylline or aminophylline such as Slo-bid and Somophyllin, amphetamines such as Dexedrine and diet pills, steroids such as cortisone and prednisone, thyroid drugs, and the withdrawal from the use of sleeping pills, tranquilizers, and antidepressants. (See list of drugs that can cause insomnia)

If you have a sleeping problem and use one of these drugs, or if the problem began when you started using another drug, talk to your doctor. Tell him or her all the drugs (over-the-counter and prescription) you are taking. It might be possible to change the drug or lower the dosage to help you sleep. Returning to sleeping pills to get past withdrawal effects will only place you in a vicious cycle.

An excellent review of nonpharmacologic approaches to managing insomnia offers suggestions far more sensible, less dangerous, and less expensive than reliance on prescription drugs. As the authors of this review stated, “Nonpharmacological treatments not only cause fewer side effects, but they can sustain long-term improvements more successfully than pharmacological treatments.”[23]

We review some of the suggestions from this review below:

Stimulus Control

Instructions given to patients for this “treatment” include the following:

  1. Go to bed only when you feel tired.
  2. Use the bed and bedroom for sleep and sex. For example, do not read books or magazines, watch TV, eat, or worry while in bed.
  3. Leave the room if you do not fall asleep within 15–20 minutes. Remain in the other room for as long as you wish or need. Return to bed only when you feel sleepy again.
  4. If you still cannot sleep, repeat step 3. Do this as often as necessary throughout the night.
  5. Get up at the same time every morning regardless of how much sleep you obtained the night before (use an alarm clock if necessary).
  6. Avoid napping.

Sleep Hygiene Education

  1. Avoid the use of caffeine-containing products (including tea, coffee, and chocolate), nicotine, and alcohol, especially later in the day.
  2. Avoid heavy meals within two hours of bedtime.
  3. Avoid drinking fluids after supper to prevent frequent nighttime urination.
  4. Avoid environments that will make you really active after 5:00 p.m. (i.e., avoid noisy environments).
  5. Only use your bed for sleep. Sit in your chair when you just want to relax.
  6. Avoid watching television in bed (i.e., watch it in your chair).
  7. Establish a routine for getting ready to go to bed.
  8. Set time aside to relax before bed, and utilize relaxation techniques.
  9. Create an atmosphere conducive to sleep: Keep yourself at a comfortable temperature by modifying the number of blankets you use. Use earplugs if it is too noisy. Make the room darker if there is too much light (e.g., close the door). Put an extra mattress on your bed if it is uncomfortable.
  10. When in bed, relax and think pleasant thoughts to help you fall asleep.
  11. Get up at the same time every day, including weekends. Use an alarm clock if it will help.
  12. Avoid taking daytime naps. If you have to take them, make sure you do so before 3.00 p.m. and that the total time napping does not exceed one hour.
  13. Pursue regular physical activity, such as walking or gardening, but avoid vigorous exercise too close to bedtime.

Which Tranquilizers or Sleeping Pills Should You Use, If Any?

Although we strongly discourage the use of these drugs in most situations, especially for older adults, there are some perfectly competent physicians who, in very well defined circumstances and for very short periods of time, will prescribe them. But even the labeling approved by the Food and Drug Administration for all of the tranquilizers has to state, “Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic [tranquilizer].”[24],[25] (See the six rules for safer use below)

As mentioned at the beginning of this section, older adults should never use barbiturates as sleeping pills or tranquilizers. Other drugs such as meprobamate (MILTOWN, EQUANIL), hydroxyzine (VISTARIL, ATARAX) for sleep, glutethimide (DORIDEN), chloral hydrate (NOCTEC), and methyprylon (NOLUDAR) should also not be used.[26]

 We do not recommend the use of any benzodiazepines. Here is how the large proportion of older adults who are using these drugs to their physical and mental detriment can stop using them, more safely. If you have been taking any of these drugs for longer than several weeks continuously, there is a good chance that you have become addicted. Stopping the drugs suddenly (going “cold turkey”) is a bad idea. With the help of your doctor, work out a schedule for slowly tapering down the amount of tranquilizer or sleeping pill by an average of 5 to 10% each day. Keep a written record of the dosage reduction schedule with you. This will greatly reduce the difficulty of stopping the use of these drugs.

These 13 benzodiazepine drugs are different from each other, and the difference has to do with the different ways in which they are dangerous for older adults. The World Health Organization specifically recommends that older adults should not use the sleeping pill DALMANE (flurazepam), “owing to a high incidence of adverse effects.”[27]

Seven other benzodiazepines are also more slowly cleared out of the body, especially in older adults, and can therefore accumulate, leading to higher blood levels and increased risks. These drugs, which also should be avoided by older adults, are diazepam (VALIUM), chlordiazepoxide (LIBRIUM), clorazepate (TRANXENE), prazepam (CENTRAX), halazepam (PAXIPAM), quazepam (DORAL), and estazolam (PROSOM).

Another widely used sleeping pill, triazolam (HALCION), should also be avoided by older adults because it is so short-acting that it can cause rebound insomnia (increased sleeping problems when the drug effect has worn off), anxiety, serious amnesia (forgetfulness or memory loss in which long periods of time can completely disappear from memory), and violent, aggressive behavior. In 1992, Public Citizen’s Health Research Group petitioned the Food and Drug Administration to ban Halcion. The sleeping pill estazolam (PROSOM) is in the same class as Halcion and, according to The Medical Letter, there is no reason to use it.[27] It also has the disadvantage of slow clearance from the body.

In an article on how 11 of these benzodiazepines compare with one another as far as memory loss (a serious problem especially in older adults), geriatric drug expert Dr. Peter Lamy stated that oxazepam had less memory impairment than all other benzodiazepines except clorazepate,[28] a long-acting tranquilizer that should not be used by older adults for the reasons mentioned above. However, WorstPills.org categorizes oxazepam as Do Not Use.

In summary, the only prescription tranquilizer or sleeping pill that we advise for limited use in older adults is buspirone (BUSPAR).