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Vol 42 No 12 December 2004

dtb
Drug and Therapeutics Bulletin

Whats wrong with prescribing hypnotics?

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Teriparatide for postmenopausal osteoporosis

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Thank you to contributors

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The independent review of medical treatment

Whats wrong with prescribing hypnotics?

Expert bodies have long advised that use of hypnotic drugs should be limited to short courses for acutely
distressed patients and should generally be avoided in elderly people.13 Despite this, more than 10 million
prescriptions for hypnotics continue to be dispensed each year in England alone, mostly for benzodiazepines
and drugs with similar actions such as zaleplon, zolpidem and zopiclone (so called Z-drugs).4 Around 80%
of all such prescriptions are for people aged 65 years or over,5 and many patients remain on the drugs for months
or years.6 Such prescribing carries many potential hazards for patients, including risk of dependence, accidents
and other adverse effects on health.7 Here we review how the risks from hypnotic drugs can be minimised.

Background
The term insomnia is used loosely to describe many symptoms, including difficulty getting to sleep, frequent nocturnal awakenings, early morning waking, and waking
unrefreshed.8,9 Depending exactly how insomnia is defined,
its reported prevalence in the general population has ranged
from 6% to 48%.810 Up to 15% of adults report persistent
and/or severe symptoms (i.e. on at least 3 nights per week,
for at least 1 month), and the rate is higher in women,
older people and those with medical or psychiatric disorders.9,11 Such symptoms may be associated with daytime
tiredness, functional impairment, susceptibility to accidents,
and medical and psychiatric morbidity.8
Potential causes of insomnia include external stimuli (e.g.
light, noise) or somatic stimuli (e.g. pain, heartburn, dyspnoea, restless legs); physiological disturbance (e.g. effects
of shift work or jet lag); psychological disorders (e.g. anxiety, depression, substance misuse); and sleep-disturbing effects of caffeine, alcohol and prescribed or over-the-counter
medicines (e.g. sympathomimetic drugs, beta-blockers, diuretics, selective serotonin re-uptake inhibitors).8,9 Primary
insomnia is a diagnosis of exclusion, and accounts for around
30% of chronic insomnia.12

Principles of management
General measures
The patient should be asked about the pattern, duration
and severity of their insomnia symptoms. Underlying causes
should be sought through a careful medical, psychiatric and
drug history and examination and, wherever possible, corrected before considering specific treatment for insomnia.
Sometimes the likely cause will be obvious to the patient.
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BNF 4.1.1

Patients should be asked specifically about their use of alcohol, which is often drunk inappropriately to aid sleep.
Such use often aggravates insomnia and has many other
potential problems.13 A diary of sleep (including daytime
naps) and daytime activities (e.g. recording mealtimes, work,
exercise and intake of coffee, tea and alcohol) may reveal
behaviour patterns unconductive to sound sleep, and can
provide a clearer picture of exactly how much sleep the patient is getting.8 All patients should be advised about lifestyle adjustments to promote restful sleep (sleep hygiene),
including moderating caffeine and alcohol consumption;
limiting daytime naps; avoiding large meals, vigorous exercise and stimulating activities late in the evening; keeping
regular hours, ideally going to bed and rising at the same
times each day; and ensuring that the bedroom is comfortable and quiet.8,12,13 For many patients, such measures may
be all that is required to restore a better sleep pattern.

Psychological treatments
Several types of brief cognitive and behavioural intervention and relaxation therapy can help to regulate the sleepwake cycle, curtail sleep-incompatible behaviour, and
re-establish normal sleep patterns in patients with insomnia.14 Evidence suggests that benefit from such interventions is comparable to that with current hypnotic therapy
in the short term (although slower in onset),11 is well maintained in the 6 months following therapy,14,15 and could
be delivered cost-effectively in primary care.15 Currently,
however, a lack of trained staff limits the scope for many
of these treatments in NHS primary care.

The role of hypnotic drugs

Currently marketed hypnotics are effective in promoting sleep
in the short term, but there is little evidence to support their
efficacy during long-term use.8,12,1618 Because of concerns
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Whats wrong with prescribing hypnotics?

about adverse effects, including the risk of dependence, a

hypnotic should only be used when sleep disturbance markedly affects the life of the individual or his or her family, and
when other approaches have failed.13 Even then, it should
be used in the lowest effective dose for the shortest possible
period, preferably intermittently (e.g. one night in three)
rather than regularly.7,8,12,13,17 For example, for a distressed
patient with insomnia following an acute traumatic event,
23 nights is probably the longest for which a hypnotic should
be prescribed. For insomnia associated with a predictably
limited illness or upset, intermittent treatment, say for up to
23 weeks at the most, is reasonable.12

short-acting: plasma concentration peaks around 1 hour after ingestion (of 10mg), and the elimination half-life is also
around 1 hour.22

Treatment with a hypnotic drug is not usually appropriate for chronic insomnia. Here, it is particularly crucial
that treatment is primarily aimed at alleviating the underlying cause, such as depression. A hypnotic should be
offered only as an adjunct to non-drug treatment of insomnia, and should be reserved for patients with the most
severe symptoms. It should be given intermittently, not
continuously, again, for at most 23 weeks.8,12

Zolpidem and zopiclone appear to have short-term efficacy similar to that of benzodiazepine hypnotics.16,18,21
However, data comparing zaleplon with currently used
benzodiazepine hypnotics are sparse. Zaleplon reduces sleep
latency compared with placebo,22 and so might help people who have difficulty falling asleep. However, it does not
seem consistently to improve the quality or duration of sleep
or reduce nocturnal awakenings.22

In the short term, benzodiazepine hypnotics hasten sleep

onset, decrease nocturnal awakenings, and increase total
sleep time in patients with insomnia.18 However, tolerance
to the hypnotic effects may develop within a few weeks of
regular use.7,17 Abrupt cessation of benzodiazepine hypnotics
(particularly short-acting drugs) may be followed by rebound insomnia.17,23

While annual prescriptions for benzodiazepine hypnotics

fell from 10 million to around 6 million in England between 1993 and 2003, those for the Z-drugs, zaleplon,
zolpidem and zopiclone, rose from 0.3 million to over 4
million over the same period4 (1993 data available from
the Prescription Pricing Authority). This suggests that
prescribers may believe that changing to a Z-drug can
avoid the problems associated with regular hypnotic use.
However, in reality, the precautions needed are just as stringent as those for benzodiazepines.

Studies of varying design and duration have reported that

tolerance occurs infrequently with Z-drugs in healthy adults
and patients with insomnia.21,22,24 Nevertheless, the summaries of product characteristics (SPCs) for all three Zdrugs warn that tolerance can occur after repeated use for a
few weeks, and none of the drugs is licensed for treatment
for longer than 4 weeks (2 weeks for zaleplon), including
tapering of the dose.2527 Rebound insomnia is reported to
be uncommon on cessation of Z-drugs.21,22,24 However, in
general, published randomised comparisons with
benzodiazepines have not given data on the frequency of
symptoms associated with withdrawal of the drugs.10

Mode, speed and duration of action

Adverse effects

While the Z-drugs are chemically distinct from benzodiazepines, both classes of drug work in the same way. Both
enhance neuronal inhibition by gamma-aminobutyric acid
(GABA), by binding to specific sites (benzodiazepine
receptors) on GABAA receptors in the brain.19,20 Various
benzodiazepine receptor subtypes are thought to mediate
different functional effects (e.g. 1 subtypes have been linked
to sedative, hypnotic and amnesic effects; 2 and 3 to
anxiolytic effects).20 Benzodiazepines and zopiclone are nonselective agonists at these sites,19,20 while zolpidem and
zaleplon are more selective for 1 subtypes (which, in theory,
should minimise non-hypnotic effects).21,22 However, the
clinical relevance of such selectivity is unproven.

Hypnotics can cause dose-related over-sedation and cognitive impairment, which may manifest as residual, next-day
hangover effects. The problems are best minimised by use of
a drug with a short or medium duration of action (less than
8 hours) given only intermittently in the lowest effective
dose.20 Elderly people are especially vulnerable to over-sedation because they eliminate the drugs more slowly, are more
susceptible to CNS depression, and are more likely to be on
potentially interacting drugs.5 These are compelling reasons
for trying to avoid use of hypnotics completely in elderly
people. If a hypnotic is given, the dose for people aged over
65 years should be no more than half the usual adult dose.

Benzodiazepines and Z-drugs

Both benzodiazepine hypnotics and Z-drugs have a rapid

onset of action (between 30 and 90 minutes), but Z-drugs
are shorter-acting than any currently licensed benzodiazepine
hypnotic.20 Among the latter, the duration of action of loprazolam (elimination half-life 612 hours) and lormetazepam
(half-life 1012 hours) is relatively short, and that of lorazepam
(half-life 1020 hours) and temazepam (half-life 822 hours)
intermediate.7 Nitrazepam (half-life 1538 hours) and diazepam and its active metabolites (half-life 20200 hours)
are long-acting.7 The elimination half-life of zopiclone, following a usual adult dose (7.5mg), is 3.56 hours.19 For
zolpidem (10mg), it is around 2.5 hours.21 Zaleplon is very
90

Hypnotic efficacy

Dose-related over-sedation with benzodiazepine hypnotics

may manifest as ataxia, motor inco-ordination and mental
confusion, and may contribute to falls and fractures in the
elderly,28,29 and to accidents in the home, at work or while
driving.20,30 In elderly patients, even small doses can cause
acute confusional states, night-time wandering and, occasionally, paradoxical excitement;3 also, treatment-related impairment of memory and cognitive function may be wrongly
diagnosed as features of dementia.5,7,17
Because Z-drugs are shorter-acting than benzodiazepine
hypnotics, they might be expected to cause fewer residual
daytime effects. However, few randomised trials have
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Whats wrong with prescribing hypnotics?

directly compared Z-drugs with equivalent doses of currently

available short- or intermediate-acting benzodiazepines, such
as temazepam, and these have not shown consistent differences in safety or tolerability in people with insomnia.10 The
SPCs for all the Z-drugs caution that, like other sedative
and hypnotic drugs, they may cause daytime drowsiness, impaired concentration, confusion and amnesia.2527
Published studies have shown that zopiclone, in a usual nighttime dose, can impair memory and driving ability for up to
11 hours in healthy adults, and taking the drug may increase
the likelihood of being involved in a road accident.20,30 Nextday impairment has also been shown with higher doses of
zolpidem, or doses taken during the night,20,21 and use of the
drug has been associated with an increased risk of hip fracture in older patients.29 In usual dose (10mg), zaleplon appears to have no detectable effects on psychomotor
performance or driving when taken late in the night, up to
2 hours before scheduled waking time.20 Nevertheless, the
company advises that patients should not use or undertake
activities requiring full psychomotor co-ordination for 4 hours
or more after taking zaleplon.27 Like benzodiazepines, Zdrugs occasionally produce paradoxical stimulant effects and
adverse psychiatric reactions. Other effects include
gastrointestinal disturbance (nausea, dyspepsia) and, with
zopiclone, a bitter or metallic taste.
All patients (and especially those who drive or operate machinery) must be warned about the risks of hangover effects
if prescribed any hypnotic drug. All hypnotics can depress
respiration, so should be avoided in patients with respiratory
failure and obstructive sleep apnoea; all have additive effects
with alcohol and other CNS depressants. Prescribers must
check that the patient is not using potentially interacting
prescribed or over-the counter medicines or herbal remedies.

Risk of dependence and misuse

All currently marketed hypnotics have been associated with
at least some features of physical and/or psychological dependence, and have demonstrated a potential for misuse
and dose escalation in at least a minority of patients.7,17,19
Dependence on benzodiazepines can develop within a few
weeks or months of regular use, and may manifest as chronic
reliance on regular prescriptions; unsuccessful efforts to cut
down or stop; and rebound insomnia or other withdrawal
symptoms on stopping treatment.7 Withdrawal effects occur in around 3045% of patients taking regular therapeutic doses long term.7 They may include acute anxiety
symptoms, perceptual distortions, hallucinations, depression and, uncommonly, seizures and delirium.7,17
Misuse of benzodiazepines is common among people with
alcohol dependence and in polysubstance misuse.31,32 Also,
very high doses of benzodiazepines (often temazepam)
are sometimes swallowed, snorted or injected intravenously as euphoriants in their own right.17 Such misuse
can cause severe problems, including fatal overdose and,
in those who inject, tissue necrosis, gangrene and transmission of hepatitis and HIV.31,32

Although tolerance and rebound insomnia are reported

to be uncommon phenomena with Z-drugs, the SPCs
for all three warn of the possibility of physical and psychological dependence and withdrawal effects. Dependence on Z-drugs is a recognised risk for some patients
and its incidence may be increasing.33 Misuse of zopiclone
or zolpidem, characterised by massive dose escalation and
withdrawal symptoms, has mainly been reported in patients with a history of drug or alcohol misuse or other
psychiatric disorder.19 However, misuse of zolpidem for
anxiolytic and stimulant actions has also been reported in
patients without these characteristics.34
Although the worldwide number of reports of dependence and misuse of Z-drugs is low, there is a clear need
for vigilance, particularly given the slowness, historically,
in recognising problems with psychoactive drugs. Importantly, studies designed to test comparative risks of dependence with benzodiazepines and Z-drugs have not
been carried out a major gap in knowledge. As with
other hypnotic drugs, Z-drugs are best avoided in people
with a history of alcohol or drug misuse, and should only
be used in strict accordance with their SPCs.

Other drugs
The risk of adverse effects (e.g. dependence, dangerous
respiratory depression in overdose) generally outweigh potential benefits of the older hypnotics, clomethiazole* and
chloral hydrate, and these drugs are best avoided.13 Barbiturates too are obsolete as hypnotics, because of the dangers of dependence and overdose.
In patients in whom sleep disturbance is thought to be a
manifestation of underlying depression, treatment with an
antidepressant with sedative properties (e.g. amitriptyline,
mirtazapine, trazodone), in full therapeutic dose, is reasonable. There is no evidence that such treatment helps to relieve insomnia in patients who do not have depression, and
its use risks potentially serious adverse effects (e.g.
antimuscarinic effects and cardiotoxicity with amitriptyline).8
Sedative antihistamines, such as promethazine and diphenhydramine, are widely purchased over-the-counter as sleep
aids. However, sound evidence for their efficacy is lacking,
hangover effects are common, and rebound insomnia can
occur after prolonged use. Other products used include
herbal preparations, such as valerian (which occasionally
causes cardiotoxicity or hepatotoxicity) and the hormone
melatonin. Melatonin is not licensed in the UK, so products are not subject to the usual statutory safety testing or
quality-control checks. Evidence for its hypnotic efficacy
is weak and no large-scale studies have been published.

Withdrawing hypnotics
There is little justification for repeat prescribing of
hypnotics. Although patients often insist that their sleeping tablet is helping them, for many, if not most, of those
on long-term hypnotics, gradual withdrawal is desirable

* This new spelling reflects the use of recommended International Non-proprietary Names (rINNs) instead of former British Approved Names (BANs), as required by European
law. For more information, see the British National Formulary, or http://medicines.mhra.gov.uk/inforesources/productinfo/banslist.pdf
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Whats wrong with prescribing hypnotics?

and achievable. In a recent study, 81 of 104 patients (mean

age 77 years), who wished to stop benzodiazepine hypnotics
after many years of use, were able to withdraw successfully
with blinded tapering of the dose (i.e. with gradual substitution of placebo), plus psychological support, over 89
weeks.5 In the study group as a whole, cognitive function
improved, without detrimental effects on sleep or an increase in anxiety, when compared with a control group who
opted to stay on hypnotics. In a recent randomised trial,
involving 284 patients on long-term benzodiazepines
(mainly hypnotics), 39% of those receiving either of two
brief interventions (a short consultation or a letter from
their GP advising gradual reduction in benzodiazepine intake) achieved at least a 25% reduction in their use of
benzodiazepines;35 24% of a control group who completed
an assessment and were randomised to usual GP care
also reduced their benzodiazepine intake by at least 25%.
These studies excluded several categories of patients (e.g.
because of psychiatric illness, or because withdrawal of
hypnotics was considered inappropriate), and other patients declined to take part. Nevertheless, the findings,
together with those of earlier studies36,37 demonstrate that,
in selected patients, a high rate of success can be achieved,
even after many years of benzodiazepine use, using fairly
simple interventions. The key strategies are gradual tapering of dosage plus, when necessary, psychological support.38 The same approach seems reasonable for long-term
users of other hypnotics. For those who have difficulty
withdrawing, switching to an equivalent dose of a longacting benzodiazepine, such as diazepam, followed by
dosage reductions in small steps, is suggested.3

Cost considerations

92

adverse effects specifically related to that drug does NICE

recommend switching to a different hypnotic.
The cost of commonly used licensed hypnotic drugs, given
at usual adult doses for 14 days, ranges from around 0.50
0.80 for temazepan to around 3.404.00 for zaleplon.

Conclusion
The current and long-standing high level of prescribing of
hypnotic drugs, mostly in older people, represents a risk to
individual and public health and cannot be justified. A change
in culture, and education about sleep and sleeping tablets, is
needed. Hypnotic drugs should, in general, be given only for
very short periods (ideally, intermittently and for no more
than a few days) to alleviate acute distressing insomnia caused
by short-lasting events, illnesses or upsets. They should only
be given after careful assessment, and after education and
appropriate non-drug measures have proved insufficient. To
minimise residual next-day sedative effects, a shorter-acting
drug, given in the lowest effective dose, is a better choice
than a longer-acting drug. However, in elderly people, it is
safer to avoid hypnotics altogether, wherever possible.
Long-term use of hypnotic drugs has not been proven to
be effective for patients with chronic insomnia, and should
generally be avoided. In such individuals, first-line management should be directed at identifying and treating
any underlying cause (such as depression); alongside this,
psychological and/or behavioural treatments are a more
suitable approach than hypnotic drugs. To enable full implementation of this approach, there should be an increase
in the number of appropriately trained staff in the NHS.

The National Institute for Clinical Excellence (NICE)

recently recommended that because of lack of compelling evidence to distinguish between zaleplon, zolpidem,
zopiclone or the shorter-acting benzodiazepine hypnotics,
the drug with the lowest purchase cost (taking into account daily required dose and product price per dose)
should be prescribed.33 Only if the patient experiences

All currently available drugs appear capable of causing dependence with regular use, and should be treated as such.
Patients should be advised of this risk, and should not be
issued with repeat prescriptions without reassessment.
Many long-term users of benzodiazepine hypnotics are able
to reduce or stop their use of these medications, with benefit to their health and without detriment to their sleep, if
given simple advice and support during dose-tapering.

[M=meta-analysis; R=randomised controlled trial]

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