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ANXIETY AND INSOMNIA
Mental Health Foundation Publication
UK · 1994
Early in 1990, two thousand former tranquilliser addicts represented by 485 firms of solicitors banded together to sue the two big drug companies that market Valium and Ativan, the most popular tranquillisers in the UK. The first writs claimed that the drugs were marketed without warning – not only that there was no proof that long-term use was beneficial, but also that it could lead to addiction with physical symptoms of withdrawal.
In a classic case of "blame the patient", Roche Products, the Swiss-owned manufacturer of Valium, made their position clear in hand-outs to doctors and in the Data Sheet Compendium: addiction largely occurs in those people with addictive personalities, particularly if high doses are administered.
Defending tranquilliser use, Dr James Le Fanu, the then resident Second Opinion of the Independent newspaper (January 28, 1990) opined that clear-cut evidence of the addictive nature of Valium is "difficult to demonstrate. Patients with chronic anxiety helped by Valium might be suffering from deficiency of a Valium-like neurotransmitter in the brain. The fact that over half the patients who stop tranquillisers are back on them within a year supports this."
Although the tranquilliser case collapsed, the safety and efficacy of tranquillisers continues to be hotly debated, but what is clear is that there are many things which your doctor should be telling you about them before he hauls out his prescription pad.
Valium and Ativan belong to a category of drugs called benzodiazepines. They were introduced in the 1960s as a so-called safer alternative to what were considered the more dangerous habit-forming barbiturates. Although some benzodiazepines are marketed as tranquillisers (that is, anti-anxiety pills or anxiolytics) and some as sleeping pills (hypnotics), all benzodiazepines do much the same thing – although some do it faster or longer than others and each drug has its own idiosyncrasies.
Those that are long acting-diazepam (Valium), flurazepam (Dalmane), nitrazepam (Mogadon) and flunitrazepam (Rohypnol) – have intermediate-to-fast absorption, but take several days to clear the body. Intermediate acting drugs like oxazepam, lorazepam (Ativan) and temazepam (Normison) have slow-to-intermediate absorption and clear the body in 21 to 24 hours. The short-acting products like triazolam (Halcion) and midazolam (Hypnoval) take a moderate time to absorb and leave the body in a few hours.
Despite the fact that the Committee on Safety of Medicines recommends that these drugs should only be taken for two or four weeks (and that sleeping pills use should be intermittent if possible) some one and a quarter million people are long-term users. According to Professor Malcolm Lader of the Institute of Psychiatry, who pioneered studies on the danger of tranquillisers in the late 1970s, at any one point eight out of every 100 people will be taking benzodiazepines, which places them among the most popular drugs prescribed.
Chronic usage is even more pronounced among older adults and women of all ages. The Health Research Group in America found that nearly one-fifth of all Americans 65 and older used tranquillisers daily for at least one year and 11 per cent, hypnotics for the same time period. The Association of Community Health Councils report in Britain identified two-thirds to three-quarters of all those taking tranks or sleeping pills as women.
No benefit over time
Absolutely no proof exists that there is any benefit to taking this category of drugs over time. In a round-up report on sleeping pills in the New England Journal of Medicine (January 25, 1990) authors Drs J Christian Gillian and William Byerley pointed out that there havenít been any extensive studies of long-term use at recommended doses. As far as the drugs' effectiveness, "In the average sleep laboratory study, total sleep time increased by only about 30 minutes (about 8 to 12 per cent) during the first three nights of treatment with hypnotic drugs, as compared with a placebo," they wrote.
The authors also argue that improvement with some drugs occurred within one week, but not after that. "The implication is that in many patients chronic insomnia slowly improves, either spontaneously or because of the circumstances of the study" (by that they mean that the study required patients to sleep at regular times, which tends to promote sleep). In another study, "no substantial improvement was observed at any point during a two-week trial, even though rebound insomnia [difficulty sleeping once the drug wears off] occurred during the first night after withdrawal", they added.
As for the drugís effectiveness with anxiety, the British Journal of Psychiatry reported a study of 90 patients, half given benzodiazepines and half a brief dose of counselling (Catalan et al, 1984). The non-medical group recovered as quickly as those given the drug. In at least three published studies, sugar pills have worked as well as tranquillisers in getting patients better.
In many instances, some of these drugs actually increase anxiety or sleeplessness, particularly after they are stopped. Although the most common side effects are drowsiness or lack of co-ordination, these drugs can also cause agitation, excitement or rebound insomnia. According to the British Medical Journal (Feb 17,1990), "In some patients the very short acting triazolam may increase wakefulness in the early hours, presumably by a withdrawal mechanism." Author Brian Ballinger also points out that rebound insomnia can occur when you've stopped the drug after only using it for a few weeks.
Valium's paradoxical effect
In the Physicians' Desk Reference, the drug handbook of most American doctors, Roche itself admits that Valium can often have a "paradoxical effect", causing "acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation." And though the benzodiazepines are often taken for the anxiety accompanying sexual problems, larger doses (10 mg a day or more) can actually impair a man's potency and prevent a woman from achieving orgasm. Once again, these drugs can cause the very problem they're supposed to cure.
One of the biggest risks of using tranquillisers, if you're over 60, is breaking your hip – a serious health risk in older adults. Because these drugs can cause drowsiness in the day and have hangover effects, particularly in older adults or those whose liver function is impaired, using tranquillisers can cause you to fall. The Health Research Group estimates that of the 227,000 hip fractures that occur each year in America, almost exclusively in older people, some 10,000 are due to the use of sleeping pills or tranquillisers. An uncomfortable break in a younger person, a hip fracture can be life-threatening in an older person.
The medical profession and the drug companies now virtually take as read the fact that benzodiazepines in regular therapeutic doses can be highly addictive. "We knew from the start that patients taking markedly increased doses could get dependent, but thought only addictive personalities could become dependent and that true addiction was unusual," says Professor Lader. "We got that wrong. What we didn't know, but know now, is that even people taking therapeutic doses can become dependent."
Dr Sandra File of the London University School of Pharmacy has estimated that two-fifths of people on normal doses of tranquillisers are addicted to them. Professor Lader believes that estimate is unduly conservative and that the truer figures are closer to between one-sixth and one-third of all long-term users. The Health Research Group goes as far as to say that "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 addicted." Peter Tyrer and Siobhan Murphy writing in the British Journal of Psychiatry (1987) say that treatment of just four to six weeks can be "followed by a significant incidence of withdrawal problems if the drug is stopped suddenly." Even Roche, in a leaflet to doctors, notes that one-quarter of all benzodiazepine patients will never come off the drug!
Wyeth-Ayerst Laboratories, which produces Ativan, tacitly acknowledges the addictive potential of their product in their Information for Patients section of their entry in the PDR: "To assure the safe and effective use of Ativan (lorazepam) patients should be informed that benzodiazepines may produce psychological and physical dependence. It is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing the drug."
According to Wyeth, withdrawal symptoms include convulsions, abdominal and stomach cramps, vomiting, sweating, tremors, agitation, nervousness and sleeplessness. The reaction causes many patients mistakenly to think that they still need the drug and perpetuates their dependence on it. Both short- and long-acting drugs cause withdrawal symptoms. The main difference is how long it takes for them to produce their worst symptoms (in short-acting drugs, one day; in long-acting ones, 10 days). In Professor Lader's experience, twice as many Ativan patients become addicted to the drug than patients on other drugs, particularly as the dosage levels are twice that of other benzodiazepines. Roche has even launched a drug called Anexate to help ease withdrawal symptoms in patients by substituting a longer acting drug for a shorter acting one.
Benzodiazepines decrease mental functions, according to many studies. Professor Lader has conducted two small studies showing that people with a history of benzodiazepine use (particularly Ativan) have slightly abnormal brain scans (to be fair, this could be from alcohol use or have been present before the patient's anxiety problem, he points out).
In a study of 308 older adults with decreased mental functioning at the University of Washington, quoted by the Health Research Group, in over 11 per cent the problem was caused by a drug and in nearly half of those, by tranquillisers or sleeping pills. The HRG uses these figures to extrapolate that some 75,000 cases of drug induced senility in the US are likely to be caused by this category drug. What is often thought of as the forgetfulness or senility of old age may simply be chemically produced.
The most significant mental side-effect, says Professor Lader, is memory impairment. A patient's memory may return to normal after he stops the drug – or his amnesia may persist for a long time. Benzodiazepines also affect his ability to concentrate. One study showed that drugs which take a long time to leave the system are more likely to impair performance. And most symptoms get worse, the higher the dose.
Concerned about the addictive potential of benzodiazepines, the Committee on Safety of Medicines has issued recommendations to doctors and drugs companies for prescribing. The Royal Pharmaceutical Society has followed the committee's lead in advising pharmacies to counsel patient's on the risks of addiction before filling out medium- or long-term prescriptions for these drugs. This may help to curb the all too common practice that Dr Lader describes of doctors refilling requests for prescriptions for tranquillisers and sleeping pills without reviewing a patient's history or seeing him in person.
Nevertheless, most of us must count upon the good will of our local GP or chemist to warn us about benzodiazepines, as the information given to us by drug companies often differs markedly from that given to our doctors. The European Community is now implementing plans to rectify this situation to some extent. Patient Packet Inserts (PPIs) will be required to include comprehensive information on all drugs. This represents a major step forward in helping patients to decide for themselves whether a few weeks of quick relief are worth all the problems of withdrawal or the risk of numbering among the one-quarter or so who remain permanent tranquilliser junkies.
A natural approach to anxiety
There are several effective and safe ways to help alleviate anxiety in your life.
Counselling or therapy may help identify and manage the sources of anxiety in your day-to-day life. For many people anxiety and depression form a vicious cycle, so many of the alternatives to depression are also applicable to anxiety as well. While you are working through your anxieties there are alternative methods such as herbs which you can use to support yourself.
When anxiety is due to stress, Panax ginseng may prove to be helpful. In one study, nurses who switched from day to night duty were asked to rate themselves for competence, mood, and general well being and were given an objective test of psychophysical performance, blood counts and blood chemistry The group administered ginseng had higher scores in competence, mood parameters and objective psychophysical performance, when compared with those receiving placebo (Comp Med East West,1982; 6: 277-82).
The herb Ashwagandha (sometimes referred to as "Indian ginseng", though it is not part of the Panax family) has been used in Ayurvedic medicine for more than 2500 years to treat stress. There are several studies to show its beneficial effects (Ind J Med Res,1991; 94(B): 312-5; Acta Nerv Super,1990; 32(1):1-5).
WDDTY panellist Harald Gaier believes that some insomnia can be caused by food allergies or sensitivities. In his experience there is about a six-hour delay between eating a food you may be allergic to and a feeling of being wide awake-probably due to an outpouring of various neurohormones and thyroid hormones (Paediatrics,1985; 76(6): 880-4).
Although it is well known that caffeine, in the form of tea, coffee, chocolate or cocoa causes insomnia (Clin Pharmacol Ther,1976; 20: 682-9), less is known about alcohol. In spite of a sedative, effect at first, drinking alcohol can significantly interfere with the quality of sleep (Electroencephalogram Clin Neurophysiol,1980; 48(6): 706-9).
When the cause isn't food or drink, insomnia is often linked to depression. It's also caused by tension, pain, emotional arousal, discomfort, disruption of one's surroundings or a change in environment or even a fear of sleeping.
A very effective over-the-counter remedy is Passiflora Lehning Drops, which contains Avena sativa, Pass flora, Belladonna, Secale and Valerian – all in low homeopathic potencies. Studies show it to be significantly superior to orthodox remedies (Editions Lehning,1992; Passiflora:1-6).
Valerian root on its own has also been shown to combat insomnia (RF Weiss, Herbal Medicine, Gottenburg: A B Arcanum, 1988; Pharmacol Biochem Behav,1989; 32:1065-6).
Nicotinamide, a form of vitamin B3, also known as niacinamide, appears to have hypnotic effects comparable to those to the benzodiazepine drugs (Nature,1979; 278: 563-5).
Finally, regular exercise – that is, elevating you heartbeat by 50 per cent for at least 20 minutes during the day and not before retiring – should also improve sleep quality.
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