Painful diabetic neuropathy (under expert supervision)
▶ Adult: Apply 3–4 times a day for 8 weeks then review,
dose to be applied sparingly, not more often than every
Peripheral neuropathic pain in non-diabetic patients
(under the supervision of a physician)
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: (consult product literature)
Symptomatic relief in osteoarthritis
▶ Adult: Apply 4 times a day, dose to be applied
sparingly, not more often than every 4 hours
GENERAL CAUTIONS Avoid contact with broken skin . avoid
▶ With topical use Avoid contact with eyes . avoid hot shower
or bath just before or after application (burning sensation
enhanced). avoid inhalation of vapours . not to be used
▶ With transdermal use avoid contact with the face, scalp or in
proximity to mucous membranes . avoid holding near eyes
or mucous membranes .recent cardiovascular events . uncontrolled hypertension
▶ With transdermal use Sensation abnormal
▶ With topical use Sneezing . watering eye
▶ With topical use Asthma exacerbated . dyspnoea . skin
burning sensation (particularly if too much used or if
administered more than 4 times daily). skin irritation
▶ With transdermal use Monitor blood pressure during
▶ With topical use Wash hands immediately after use (or wash
hands 30 minutes after application if hands treated).
▶ With transdermal use Nitrile gloves to be worn while
handling patches and cleaning treatment areas (latex
gloves do not provide adequate protection).
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (January
2011) that capsaicin 179 mg (8%) patch (Qutenza ®) is
accepted for restricted use within NHS Scotland for the
treatment of postherpetic neuralgia in patients who have
not achieved adequate pain relief from, or who have not
tolerated conventional first and second line treatments.
Treatment should be under the supervision of a specialist
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Butylated hydroxyanisole
Capsaicin 179 mg Qutenza 179mg cutaneous patches |
EXCIPIENTS: May contain Benzyl alcohol, cetostearyl alcohol (including
Capsaicin 750 microgram per 1 gram Axsain 0.075% cream | 45 gram P £14.58 DT = £14.58
Capsaicin 250 microgram per 1 gram Zacin 0.025% cream | 45 gram P £17.71 DT = £17.71
Most anxiolytics (‘sedatives’) will induce sleep when given at
night and most hypnotics will sedate when given during the
day. Prescribing of these drugs is widespread but
dependence (both physical and psychological) and tolerance
occur. This may lead to difficulty in withdrawing the drug
after the patient has been taking it regularly for more than a
few weeks. Hypnotics and anxiolytics should therefore be
reserved for short courses to alleviate acute conditions after
causal factors have been established.
Benzodiazepines are the most commonly used anxiolytics
and hypnotics; they act at benzodiazepine receptors which
are associated with gamma-aminobutyric acid (GABA)
receptors. Older drugs such as meprobamate p. 346 and
. Benzodiazepines are indicated for the short-term relief
(two to four weeks only) of anxiety that is severe,
disabling, or causing the patient unacceptable distress,
. The use of benzodiazepines to treat short-term ‘mild’
. Benzodiazepines should be used to treat insomnia only
when it is severe, disabling, or causing the patient extreme
Withdrawal of a benzodiazepine should be gradual because
abrupt withdrawal may produce confusion, toxic psychosis,
convulsions, or a condition resembling delirium tremens.
The benzodiazepine withdrawal syndrome may develop at
any time up to 3 weeks after stopping a long-acting
benzodiazepine, but may occur within a day in the case of a
short-acting one. It is characterised by insomnia, anxiety,
loss of appetite and of body-weight, tremor, perspiration,
tinnitus, and perceptual disturbances. Some symptoms may
be similar to the original complaint and encourage further
prescribing; some symptoms may continue for weeks or
months after stopping benzodiazepines.
Benzodiazepine withdrawal should be flexible and carried
out at a reduction rate that is tolerable for the patient. The
rate should depend on the initial dose of benzodiazepine,
taper off within 2–4 weeks. However, long-term users should
be withdrawn over a much longer period of several months
A suggested protocol for withdrawal for prescribed longterm benzodiazepine patients is as follows:
. Transfer patient stepwise, one dose at a time over about a
week, to an equivalent daily dose of diazepam preferably
. Reduce diazepam dose, usually by 1–2 mg every 2–
4 weeks (in patients taking high doses of benzodiazepines,
initially it may be appropriate to reduce the dose by up to
one-tenth every 1–2 weeks). If uncomfortable withdrawal
symptoms occur, maintain this dose until symptoms
. Reduce diazepam dose further, if necessary in smaller
steps; steps of 500 micrograms may be appropriate towards
the end of withdrawal. Then stop completely.
. For long-term patients, the period needed for complete
withdrawal may vary from several months to a year or
Approximate equivalent doses, diazepam 5 mg
Withdrawal symptoms for long-term users usually resolve
within 6–18 months of the last dose. Some patients will
recover more quickly, others may take longer. The addition
of beta-blockers, antidepressants and antipsychotics should
Counselling can be of considerable help both during and
Before a hypnotic is prescribed the cause of the insomnia
should be established and, where possible, underlying
factors should be treated. However, it should be noted that
some patients have unrealistic sleep expectations, and
others understate their alcohol consumption which is often
the cause of the insomnia. Short-acting hypnotics are
preferable in patients with sleep onset insomnia, when
sedation the following day is undesirable, or when
prescribing for elderly patients. Long-acting hypnotics are
indicated in patients with poor sleep maintenance (e.g. early
morning waking) that causes daytime effects, when an
anxiolytic effect is needed during the day, or when sedation
the following day is acceptable.
Transient insomnia may occur in those who normally sleep
well and may be due to extraneous factors such as noise,
shift work, and jet lag. If a hypnotic is indicated one that is
rapidly eliminated should be chosen, and only one or two
Short-term insomnia is usually related to an emotional
problem or serious medical illness. It may last for a few
weeks and may recur; a hypnotic can be useful but should
not be given for more than three weeks (preferably only one
week). Intermittent use is desirable with omission of some
doses. A short-acting drug is usually appropriate.
Chronic insomnia is rarely benefited by hypnotics and is
sometimes due to mild dependence caused by injudicious
prescribing of hypnotics. Psychiatric disorders such as
anxiety, depression, and abuse of drugs and alcohol are
common causes. Sleep disturbance is very common in
depressive illness and early wakening is often a useful
pointer. The underlying psychiatric complaint should be
treated, adapting the drug regimen to alleviate insomnia. For
example, clomipramine hydrochloride p. 373 or mirtazapine
p. 372 prescribed for depression will also help to promote
sleep if taken at night. Other causes of insomnia include
daytime cat-napping and physical causes such as pain,
Hypnotics should not be prescribed indiscriminately and
routine prescribing is undesirable. They should be reserved
for short courses in the acutely distressed. Tolerance to their
effects develops within 3 to 14 days of continuous use and
long-term efficacy cannot be assured. A major drawback of
long-term use is that withdrawal can cause rebound
insomnia and a withdrawal syndrome.
Where prolonged administration is unavoidable hypnotics
should be discontinued as soon as feasible and the patient
warned that sleep may be disturbed for a few days before
normal rhythm is re-established; broken sleep with vivid
dreams may persist for several weeks.
Benzodiazepines and the Z–drugs should be avoided in the
elderly, because the elderly are at greater risk of becoming
ataxic and confused, leading to falls and injury.
Some anxious patients may benefit from the use of hypnotics
during dental procedures such as temazepam p. 488 or
diazepam p. 343. Temazepam is preferred when it is
important to minimise any residual effect the following day.
Benzodiazepines used as hypnotics include nitrazepam
p. 487 and flurazepam p. 486 which have a prolonged action
and may give rise to residual effects on the following day;
repeated doses tend to be cumulative.
Loprazolam p. 487, lormetazepam p. 487, and temazepam
act for a shorter time and they have little or no hangover
effect. Withdrawal phenomena are more common with the
If insomnia is associated with daytime anxiety then the
use of a long-acting benzodiazepine anxiolytic such as
diazepam given as a single dose at night may effectively treat
not licensed for long-term use; dependence has been
reported in a small number of patients. Both zolpidem
tartrate and zopiclone have a short duration of action.
There is no convincing evidence that they are particularly
useful in the elderly and their role as hypnotics is now very
Clomethiazole p. 489 may be a useful hypnotic for elderly
patients because of its freedom from hangover but, as with
all hypnotics, routine administration is undesirable and
Some antihistamines such as promethazine hydrochloride
p. 286 are on sale to the public for occasional insomnia; their
prolonged duration of action can often cause drowsiness the
following day. The sedative effect of antihistamines may
diminish after a few days of continued treatment;
antihistamines are associated with headache, psychomotor
impairment and antimuscarinic effects.
Alcohol is a poor hypnotic because the diuretic action
interferes with sleep during the latter part of the night.
Alcohol also disturbs sleep patterns, and so can worsen sleep
Melatonin p. 489 is a pineal hormone; it is licensed for the
short-term treatment of insomnia in adults over 55 years.
Benzodiazepine anxiolytics can be effective in alleviating
anxiety states. Although these drugs are sometimes
prescribed for stress-related symptoms, unhappiness, or
minor physical disease, their use in such conditions is
inappropriate. Benzodiazepine anxiolytics should not be
used as sole treatment for chronic anxiety, and they are not
appropriate for treating depression or chronic psychosis. In
bereavement, psychological adjustment may be inhibited by
Anxiolytic benzodiazepine treatment should be limited to
the lowest possible dose for the shortest possible time.
Dependence is particularly likely in patients with a history of
alcohol or drug abuse and in patients with marked
Some antidepressant drugs are licensed for use in anxiety
and related disorders. Some antipsychotic drugs, in low
doses, are also sometimes used in severe anxiety for their
sedative action, but long-term use should be avoided
because of the risk of adverse effects. The use of
antihistamines (e.g. hydroxyzine hydrochloride p. 285) for
their sedative effect in anxiety is not appropriate.
Beta-adrenoceptor blocking drugs do not affect
psychological symptoms of anxiety, such as worry, tension,
and fear, but they do reduce autonomic symptoms, such as
palpitation and tremor; they do not reduce non-autonomic
symptoms, such as muscle tension. Beta-blockers are
therefore indicated for patients with predominantly somatic
symptoms; this, in turn, may prevent the onset of worry and
Benzodiazepines are indicated for the short-term relief of
severe anxiety; long-term use should be avoided. Diazepam,
alprazolam p. 342, chlordiazepoxide hydrochloride p. 343,
and clobazam p. 336 have a sustained action. Shorter-acting
compounds such as lorazepam p. 339 and oxazepam p. 345
may be preferred in patients with hepatic impairment but
they carry a greater risk of withdrawal symptoms.
In panic disorders (with or without agoraphobia) resistant
to antidepressant therapy, a benzodiazepine may be used;
alternatively, a benzodiazepine may be used as short-term
adjunctive therapy at the start of antidepressant treatment
to prevent the initial worsening of symptoms.
Diazepam or lorazepam are very occasionally administered
intravenously for the control of panic attacks. This route is
the most rapid but the procedure is not without risk and
should be used only when alternative measures have failed.
The intramuscular route has no advantage over the oral
Buspirone hydrochloride p. 342 is thought to act at specific
serotonin (5HT1A) receptors. Response to treatment may
take up to 2 weeks. It does not alleviate the symptoms of
benzodiazepine withdrawal. Therefore a patient taking a
benzodiazepine still needs to have the benzodiazepine
withdrawn gradually; it is advisable to do this before starting
buspirone hydrochloride. The dependence and abuse
potential of buspirone hydrochloride is low; it is, however,
licensed for short-term use only (but specialists occasionally
Meprobamate p. 346 is less effective than the
benzodiazepines, more hazardous in overdosage, and can
also induce dependence. It is not recommended.
The intermediate-acting barbiturates have a place only in
the treatment of severe intractable insomnia in patients
already taking barbiturates; they should be avoided in the
elderly. Intermediate-acting barbiturate preparations
containing amobarbital sodium, butobarbital, and
secobarbital sodium are available on a named patient basis.
The long-acting barbiturate phenobarbital is still
sometimes of value in epilepsy but its use as a sedative is
The very short-acting barbiturate thiopental sodium p. 338
Increased hostility and aggression after barbiturates and
alcohol usually indicates intoxication.
▶ Adult: 15–30 mg once daily, dose to be taken at
bedtime, for debilitated patients, use elderly dose
▶ Elderly: 15 mg once daily, dose to be taken at bedtime
l CONTRA-INDICATIONS Not for use alone to treat chronic
psychosis . not for use alone to treat depression (or anxiety
associated with depression).respiratory depression
l CAUTIONS Acute porphyrias p. 1058 . hypoalbuminaemia . muscle weakness
▶ Paradoxical effects A paradoxical increase in hostility and
aggression may be reported by patients taking
benzodiazepines. The effects range from talkativeness and
excitement to aggressive and antisocial acts. Adjustment
of the dose (up or down) sometimes attenuates the
impulses. Increased anxiety and perceptual disorders are
l INTERACTIONS → Appendix 1: flurazepam
▶ Common or very common Taste altered
▶ Rare or very rare Abdominal discomfort. skin eruption
▶ Frequency not known Agranulocytosis . extrapyramidal
symptoms . leucopenia . pancytopenia . suicide attempt. thrombocytopenia
l BREAST FEEDING Benzodiazepines are present in milk, and
should be avoided if possible during breast-feeding.
Dose adjustments Manufacturer advises dose of 15 mg in
Dose adjustments Start with small doses in severe
l NATIONAL FUNDING/ACCESS DECISIONS
NHS restrictions Flurazepam capsules are not prescribable
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 19
▶ Dalmane (Meda Pharmaceuticals Ltd)
Flurazepam (as Flurazepam hydrochloride) 15 mg Dalmane 15mg
Flurazepam (as Flurazepam hydrochloride) 30 mg
capsules | 30 capsule P £6.73d Dalmane 30mg
capsules | 30 capsule P £8.63d
▶ Adult: 1 mg once daily, then increased to 1.5–2 mg
once daily if required, dose to be taken at bedtime, for
debilitated patients, use elderly dose
▶ Elderly: 0.5–1 mg once daily, dose to be taken at
l CONTRA-INDICATIONS Not for use alone to treat chronic
psychosis . not for use alone to treat depression (or anxiety
associated with depression).respiratory depression
l CAUTIONS Acute porphyrias p. 1058 . hypoalbuminaemia . muscle weakness
▶ Paradoxical effects A paradoxical increase in hostility and
aggression may be reported by patients taking
benzodiazepines. The effects range from talkativeness and
excitement to aggressive and antisocial acts. Adjustment
of the dose (up or down) sometimes attenuates the
impulses. Increased anxiety and perceptual disorders are
l INTERACTIONS → Appendix 1: loprazolam
l SIDE-EFFECTS Adjustment disorder. cognitive disorder. muscle tone decreased . speech disorder
l BREAST FEEDING Benzodiazepines are present in milk, and
should be avoided if possible during breast-feeding.
Dose adjustments Start with small doses in severe
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 19
▶ Loprazolam (Non-proprietary)
Loprazolam (as Loprazolam mesilate) 1 mg Loprazolam 1mg
tablets | 28 tablet P £18.00–£27.00 DT = £18.00d
▶ Adult: 0.5–1.5 mg once daily, dose to be taken at
bedtime, for debilitated patients, use elderly dose
▶ Elderly: 500 micrograms once daily, dose to be taken at
l CONTRA-INDICATIONS Not for use alone to treat chronic
psychosis . not for use alone to treat depression (or anxiety
associated with depression).respiratory depression
l CAUTIONS Acute porphyrias p. 1058 . hypoalbuminaemia . muscle weakness
▶ Paradoxical effects A paradoxical increase in hostility and
aggression may be reported by patients taking
benzodiazepines. The effects range from talkativeness and
excitement to aggressive and antisocial acts. Adjustment
of the dose (up or down) sometimes attenuates the
impulses. Increased anxiety and perceptual disorders are
l INTERACTIONS → Appendix 1: lormetazepam
▶ Common or very common Asthenia
pulmonary disease exacerbated . pancytopenia . saliva
altered . sexual dysfunction . SIADH . speech slurred . thrombocytopenia
▶ Frequency not known Suicide attempt
l BREAST FEEDING Benzodiazepines are present in milk, and
should be avoided if possible during breast-feeding.
Dose adjustments Start with small doses in severe
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension
CAUTIONARY AND ADVISORY LABELS 19
▶ Lormetazepam (Non-proprietary)
Lormetazepam 500 microgram Lormetazepam 500microgram
| 30 tablet P £12.38 DT = £3.08d
▶ Adult: 5–10 mg daily, dose to be taken at bedtime, for
debilitated patients, use elderly dose
▶ Elderly: 2.5–5 mg daily, dose to be taken at bedtime
l CONTRA-INDICATIONS Not for use alone to treat chronic
psychosis . not for use alone to treat depression (or anxiety
associated with depression).respiratory depression
l CAUTIONS Acute porphyrias p. 1058 . hypoalbuminaemia . muscle weakness
▶ Paradoxical effects A paradoxical increase in hostility and
aggression may be reported by patients taking
benzodiazepines. The effects range from talkativeness and
excitement to aggressive and antisocial acts. Adjustment
of the dose (up or down) sometimes attenuates the
impulses. Increased anxiety and perceptual disorders are
l INTERACTIONS → Appendix 1: nitrazepam
▶ Common or very common Movement disorders
▶ Uncommon Concentration impaired
▶ Frequency not known Drug abuse
l BREAST FEEDING Benzodiazepines are present in milk, and
should be avoided if possible during breast-feeding.
Dose adjustments Start with small doses in severe
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension
CAUTIONARY AND ADVISORY LABELS 19
▶ Nitrazepam (Non-proprietary)
Nitrazepam 500 microgram per 1 ml Nitrazepam 2.5mg/5ml oral
suspension | 70 ml P £114.00 DT = £114.00d
CAUTIONARY AND ADVISORY LABELS 19
▶ Nitrazepam (Non-proprietary)
Nitrazepam 5 mg Nitrazepam 5mg tablets | 28 tablet P £5.00
DT = £0.80d| 500 tablet P £14.29d
▶ Mogadon (Meda Pharmaceuticals Ltd)
Nitrazepam 5 mg Mogadon 5mg tablets | 30 tablet P £5.76d
▶ Adult: 10–20 mg once daily, alternatively 30–40 mg
once daily, higher dose range only to be administered
in exceptional circumstances, dose to be taken at
bedtime, for debilitated patients, use elderly dose
▶ Elderly: 10 mg once daily, alternatively 20 mg once
daily, higher dose only to be administered in
exceptional circumstances, dose to be taken at bedtime
Conscious sedation for dental procedures
▶ Adult: 15–30 mg, to be administered 30–60 minutes
Premedication before surgery or investigatory procedures
▶ Adult: 10–20 mg, to be taken 1–2 hours before
procedure, alternatively 30 mg, to be taken 1–2 hours
before procedure, higher alternate dose only
administered in exceptional circumstances
▶ Elderly: 10 mg, to be taken 1–2 hours before procedure,
alternatively 20 mg, to be taken 1–2 hours before
procedure, higher alternate dose only administered in
l UNLICENSED USE Temazepam doses in BNF may differ
from those in product literature.
Not licensed for conscious sedation for dental
l CONTRA-INDICATIONS CNS depression . compromised
airway . hyperkinesis . not for use alone to treat chronic
psychosis . not for use alone to treat depression (or anxiety
associated with depression). obsessional state . phobic
states .respiratory depression
l CAUTIONS Hypoalbuminaemia . muscle weakness . organic
▶ Paradoxical effects A paradoxical increase in hostility and
aggression may be reported by patients taking
benzodiazepines. The effects range from talkativeness and
excitement to aggressive and antisocial acts. Adjustment
of the dose (up or down) sometimes attenuates the
impulses. Increased anxiety and perceptual disorders are
l INTERACTIONS → Appendix 1: temazepam
l SIDE-EFFECTS Drug abuse . dry mouth . hypersalivation . speech slurred
l BREAST FEEDING Benzodiazepines are present in milk, and
should be avoided if possible during breast-feeding.
Dose adjustments ▶ When used for Insomnia Manufacturer
advises initiate at 5 mg once daily, increase to 10 mg or
20 mg once daily in extreme cases. Dose to be taken at
Dose adjustments Start with small doses in severe
Driving and skilled tasks Patients given sedatives and
analgesics during minor outpatient procedures should be
very carefully warned about the risks of undertaking
skilled tasks (e.g. driving) afterwards. Responsible persons
should be available to take patients home afterwards. The
dangers of taking alcohol should be emphasised.
l PROFESSION SPECIFIC INFORMATION
Dental practitioners’ formulary
Temazepam Tablets and Oral Solution may be prescribed.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
CAUTIONARY AND ADVISORY LABELS 19
Temazepam 2 mg per 1 ml Temazepam 10mg/5ml oral solution
sugar free sugar-free | 300 ml P £183.26 DT = £183.25c
CAUTIONARY AND ADVISORY LABELS 19
HYPNOTICS, SEDATIVES AND ANXIOLYTICS ›
NON-BENZODIAZEPINE HYPNOTICS AND
Insomnia (short-term use), using chloral hydrate
▶ BY MOUTH USING ORAL SOLUTION
▶ Adult: 430–860 mg once daily (max. per dose 2 g), dose
to be taken with water or milk at bedtime
Insomnia (short-term use), using chloral betaine 707 mg
(: 414 mg chloral hydrate) tablets
▶ Adult: 1–2 tablets, alternatively 414–828 mg once
daily, dose to be taken with water or milk at bedtime;
maximum 4 tablets per day; maximum 2 g per day
l CONTRA-INDICATIONS Acute porphyrias p. 1058 . gastritis . severe cardiac disease
l CAUTIONS Avoid contact with mucous membranes . avoid
contact with skin . avoid prolonged use (and abrupt
withdrawal thereafter).reduce dose in debilitated .reduce
l INTERACTIONS → Appendix 1: chloral hydrate
discontinuation). drug use disorders . gastrointestinal
discomfort. gastrointestinal disorders . headache . injury . ketonuria . kidney injury
l BREAST FEEDING Risk of sedation in infant—avoid.
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
Dose adjustments Manufacturer advises consider dose
reduction in the elderly with hepatic impairment.
l RENAL IMPAIRMENT Avoid in severe impairment.
l DIRECTIONS FOR ADMINISTRATION For administration by
mouth dilute liquid with plenty of water or juice to mask
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include black currant.
Driving and skilled tasks Drowsiness may persist the next
day and affect performance of skilled tasks (e.g. driving);
l LESS SUITABLE FOR PRESCRIBING Chloral hydrate is less
suitable for prescribing in insomnia.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 19, 27
▶ Chloral hydrate (Non-proprietary)
Cloral betaine 707 mg Cloral betaine 707mg tablets | 30 tablet P £138.59 DT = £138.59
CAUTIONARY AND ADVISORY LABELS 1(paediatric solution only), 19
(solution other than paediatric only), 27
▶ Chloral hydrate (Non-proprietary)
Chloral hydrate 28.66 mg per 1 ml Chloral hydrate 143.3mg/5ml
oral solution BP | 150 ml P £244.25 DT = £244.25
Severe insomnia (short-term use)
▶ Elderly: 192–384 mg once daily, dose to be taken at
▶ BY MOUTH USING ORAL SOLUTION
▶ Elderly: 5–10 mL once daily, dose to be taken at
▶ Elderly: 192 mg 3 times a day
▶ BY MOUTH USING ORAL SOLUTION
▶ Adult: Initially 2–4 capsules, to be repeated if
necessary after some hours. 9–12 capsules daily in
3–4 divided doses on day 1 (first 24 hours), then
6–8 capsules daily in 3–4 divided doses on day 2, then
4–6 capsules daily in 3–4 divided doses on day 3, dose
then to be gradually reduced over days 4–6, total
duration of treatment for no more than 9 days
▶ BY MOUTH USING ORAL SOLUTION
▶ Adult: Initially 10–20 mL, to be repeated if necessary
after some hours, then 45–60 mL daily in 3–4 divided
doses on day 1 (first 24 hours), then 30–40 mL daily in
3–4 divided doses on day 2, then 20–30 mL daily in
3–4 divided doses on day 3, dose then to be gradually
reduced over days 4–6, total duration of treatment for
l CAUTIONS Avoid prolonged use (and abrupt withdrawal
thereafter). cardiac disease (confusional state may
higher doses);. history of drug abuse . marked personality
disorder.respiratory disease (confusional state may
indicate hypoxia). sleep apnoea syndrome
l INTERACTIONS → Appendix 1: clomethiazole
l PREGNANCY Avoid if possible—especially during the first
l BREAST FEEDING Use only if benefit outweighs risk—
present in breast milk but effects unknown.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate to severe impairment (risk of increased
Dose adjustments Manufacturer advises consider dose
reduction in moderate hepatic disorders associated with
l RENAL IMPAIRMENT Increased cerebral sensitivity.
Dose adjustments Start with small doses in severe
Driving and skilled tasks Drowsiness may persist the next
day and affect performance of skilled tasks (e.g. driving);
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 19
EXCIPIENTS: May contain Alcohol
▶ Clomethiazole (Non-proprietary)
Clomethiazole (as Clomethiazole edisilate) 50 mg per
1 ml Clomethiazole 31.5mg/ml oral solution sugar free sugar-free | 300 ml P £30.00
CAUTIONARY AND ADVISORY LABELS 19
▶ Clomethiazole (Non-proprietary)
Clomethiazole 192 mg Clomethiazole 192mg capsules | 60 capsule P £32.80 DT = £32.80
▶ BY MOUTH USING MODIFIED-RELEASE TABLETS
▶ Adult 55 years and over: 2 mg once daily for up to
13 weeks, dose to be taken 1–2 hours before bedtime
l CAUTIONS Autoimmune disease (manufacturer advises
avoid—no information available)
l INTERACTIONS → Appendix 1: melatonin
▶ Common or very common Arthralgia . headaches . increased
disorders . urine abnormalities . weight increased
▶ Frequency not known Angioedema . galactorrhoea
l PREGNANCY No information available—avoid.
l BREAST FEEDING Present in milk—avoid.
l HEPATIC IMPAIRMENT Manufacturer advises avoid (risk of
decreased clearance; limited information available).
l RENAL IMPAIRMENT No information available—use with
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: modified-release
CAUTIONARY AND ADVISORY LABELS 2, 21, 25
Melatonin 3 mg Melatonin 3mg modified-release tablets | 120 tablet P s
Melatonin 2 mg Circadin 2mg modified-release tablets | 30 tablet P £15.39 DT = £15.39
Melatonin 1 mg Slenyto 1mg modified-release tablets | 60 tablet P £41.20
Melatonin 5 mg Slenyto 5mg modified-release tablets |
▶ Adult: 10 mg daily for up to 4 weeks, dose to be taken at
bedtime, for debilitated patients, use elderly dose
▶ Elderly: 5 mg daily for up to 4 weeks, dose to be taken
sleep apnoea . psychotic illness . severe respiratory
depression . unstable myasthenia gravis
l CAUTIONS Avoid prolonged use (and abrupt withdrawal
l INTERACTIONS → Appendix 1: zolpidem
▶ Common or very common Abdominal pain . anterograde
▶ Uncommon Confusion . diplopia . irritability
disorder. muscle weakness . psychosis .respiratory
depression . skin reactions . speech disorder. withdrawal
l PREGNANCY Avoid regular use (risk of neonatal
withdrawal symptoms); high doses during late pregnancy
or labour may cause neonatal hypothermia, hypotonia,
l BREAST FEEDING Small amounts present in milk—avoid.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment (risk of decreased
clearance); avoid in severe impairment.
Dose adjustments Manufacturer advises initial dose
reduction to 5 mg daily in mild to moderate impairment.
l RENAL IMPAIRMENT Use with caution.
Driving and skilled tasks Drowsiness may persist the next
day—leave at least 8 hours between taking zolpidem and
performing skilled tasks (e.g. driving, or operating
machinery); effects of alcohol and other CNS depressants
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Guidance on the use of zaleplon, zolpidem, and zopiclone for
the short-term management of insomnia (April 2004)
Zolpidem is recommended for the short-term
management of severe insomnia that interferes with
normal daily life, and should be prescribed for short
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 19
▶ Zolpidem tartrate (Non-proprietary)
Zolpidem tartrate 5 mg Zolpidem 5mg tablets | 28 tablet P £
Zolpidem 10mg tablets | 28 tablet P
Zolpidem tartrate 5 mg Stilnoct 5mg tablets | 28 tablet P £1.10
0.90d Stilnoct 10mg tablets | 28 tablet P £1.00 DT = £0.92d
▶ Adult: 7.5 mg once daily for up to 4 weeks, dose to be
▶ Elderly: Initially 3.75 mg once daily for up to 4 weeks,
dose to be taken at bedtime, increased if necessary to
Insomnia (short-term use) in patients with chronic
▶ Adult: Initially 3.75 mg once daily for up to 4 weeks,
dose to be taken at bedtime, increased if necessary to
l CONTRA-INDICATIONS Marked neuromuscular respiratory
weakness .respiratory failure . severe sleep apnoea
syndrome . unstable myasthenia gravis
l CAUTIONS Avoid prolonged use (risk of tolerance and
withdrawal symptoms). chronic pulmonary insufficiency
(increased risk of respiratory depression). elderly . history
of drug abuse . muscle weakness . myasthenia gravis (avoid
if unstable). psychiatric illness
l INTERACTIONS → Appendix 1: zopiclone
▶ Common or very common Dry mouth .taste bitter
▶ Uncommon Anxiety . dizziness .fatigue . headache . nausea . sleep disorders . vomiting
▶ Frequency not known Cognitive disorder. concentration
impaired . delusions . depressed mood . diplopia . drug
dependence . dyspepsia . movement disorders . muscle
weakness . paraesthesia .respiratory depression . speech
l PREGNANCY Not recommended (risk of neonatal
withdrawal symptoms). Use during late pregnancy or
labour may cause neonatal hypothermia, hypotonia, and
l BREAST FEEDING Present in milk—avoid.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment
(risk of decreased elimination).
Dose adjustments Manufacturer advises dose reduction to
3.75 mg in mild to moderate impairment, dose can be
increased with caution if necessary.
l RENAL IMPAIRMENT Increased cerebral sensitivity.
Dose adjustments Start with reduced dose of 3.75 mg.
Driving and skilled tasks Drowsiness may persist the next
day and affect performance of skilled tasks (e.g. driving);
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Guidance on the use of zaleplon, zolpidem and zopiclone for
the short-term management of insomnia (April 2004)
Zopiclone is recommended for the short-term
management of severe insomnia that interferes with
normal daily life, and should be prescribed for short
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
CAUTIONARY AND ADVISORY LABELS 19, 25
Zopiclone 3.75 mg Zopiclone 3.75mg tablets | 28 tablet P £2.49
Zopiclone 7.5mg tablets | 28 tablet P £3.75 DT
Zopiclone 3.75 mg Zimovane LS 3.75mg tablets | 28 tablet P £
2.24 DT = £0.88dZimovane 7.5mg tablets | 28 tablet P £3.26 DT
Other drugs used for Narcolepsy Dexamfetamine sulfate,
p. 350 . Methylphenidate hydrochloride, p. 348
CENTRAL NERVOUS SYSTEM DEPRESSANTS
l DRUG ACTION A central nervous system depressant.
Narcolepsy with cataplexy (under expert supervision)
▶ Adult: Initially 2.25 g daily, dose to be taken on retiring
and 2.25 g after 2.5–4 hours, then increased in steps of
1.5 g daily in 2 divided doses, dose adjusted according
to response at intervals of 1–2 weeks; dose titration
should be repeated if restarting after interval of more
than 14 days, maximum 9 g daily in 2 divided doses
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Manufacturer advises reduce dose by 20 % with
concurrent use of sodium valproate or valproic acid.
l CONTRA-INDICATIONS Major depression . succinic semialdehyde dehydrogenase deficiency
l CAUTIONS Body mass index of 40 kg/m2 or greater (higher
risk of sleep apnoea). elderly . epilepsy . heart failure (high
sodium content). history of depression . history of drug
abuse . hypertension (high sodium content).respiratory
disorders .risk of discontinuation effects including
rebound cataplexy and withdrawal symptoms
l INTERACTIONS → Appendix 1: sodium oxybate
paralysis . snoring .taste altered .tremor. urinary
disorders . vertigo . vision blurred . vomiting . weight
consciousness . mood altered .respiratory depression . seizure . sleep apnoea
l HEPATIC IMPAIRMENT Manufacturer advises caution (risk
Dose adjustments Manufacturer advises initial dose
l RENAL IMPAIRMENT Caution—contains 3.96 mmol Na+ per
l DIRECTIONS FOR ADMINISTRATION Dilute each dose with
60 mL water; prepare both doses before retiring. Observe
the same time interval (2–3 hours) each night between the
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer sodium oxybate oral
Driving and skilled tasks Leave at least 6 hours between
taking sodium oxybate and performing skilled tasks (e.g.
driving or operating machinery); effects of alcohol and
other CNS depressants enhanced.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 13, 19
ELECTROLYTES: May contain Sodium
Sodium oxybate 500 mg per 1 ml Xyrem 500mg/ml oral solution
sugar-free | 180 ml P £360.00 DT = £360.00b
l DRUG ACTION Pitolisant is a histamine H3-receptor
antagonist which enhances the activity of brain
Narcolepsy with or without cataplexy (initiated by a
▶ Adult: Initially 9 mg once daily for 1 week, then
increased if necessary to 18 mg once daily for 1 week,
then increased if necessary to 36 mg once daily, dose to
be taken in the morning with breakfast, dose can be
decreased (down to 4.5 mg per day) or increased (up to
36 mg per day) according to response and tolerance
l INTERACTIONS → Appendix 1: pitolisant
altered . nausea . sleep disorders .tremor. vertigo . vomiting
reactions . sweat changes .tinnitus . urinary frequency
increased . visual acuity decreased . weight decreased
(review treatment if significant). weight increased (review
treatment if significant) . yawning
▶ Rare or very rare Behaviour abnormal . cognitive
impairment. confusion . loss of consciousness . memory
loss . obsessive thoughts . photosensitivity reaction . sense
of oppression . swallowing difficulty
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception in women of childbearing potential
for at least 21 days after treatment discontinuation—
pitolisant may reduce the effectiveness of hormonal
l PREGNANCY Manufacturer advises avoid unless potential
benefit outweighs risk—toxicity in animal studies.
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment; avoid in severe impairment.
Dose adjustments Manufacturer advises consider dose
increase two weeks after initiation in moderate
impairment; maximum daily dose of 18 mg.
Dose adjustments Manufacturer advises use with caution;
maximum daily dose should not exceed 18 mg.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Wakix (Lincoln Medical Ltd) A
Pitolisant (as Pitolisant hydrochloride) 4.5 mg Wakix 4.5mg
tablets | 30 tablet P £310.00 DT = £310.00
Pitolisant (as Pitolisant hydrochloride) 18 mg Wakix 18mg tablets
| 30 tablet P £310.00 DT = £310.00
CNS STIMULANTS › CENTRALLY ACTING
Excessive sleepiness associated with narcolepsy with or
▶ Adult: Initially 200 mg daily in 2 divided doses, dose to
be taken in the morning and at noon, alternatively
initially 200 mg once daily, dose to be taken in the
morning, adjusted according to response to
200–400 mg daily in 2 divided doses, alternatively
adjusted according to response to 200–400 mg once
▶ Elderly: Initially 100 mg daily
l CONTRA-INDICATIONS Arrhythmia . history of clinically
significant signs of CNS stimulant-induced mitral valve
prolapse (including ischaemic ECG changes, chest pain
and arrhythmias). history of cor pulmonale . history of left
ventricular hypertrophy . moderate uncontrolled
hypertension . severe uncontrolled hypertension
psychosis . possibility of dependence
l INTERACTIONS → Appendix 1: modafinil
abnormal . sleep disorders .thinking abnormal . vasodilation . vision disorders
disorders . skin reactions . speech disorder. suicidal
ideation .taste altered .thirst.tremor. urinary frequency
increased . urine abnormal . vertigo . vomiting . weight
▶ Rare or very rare Hallucination . psychosis
SIDE-EFFECTS, FURTHER INFORMATION Discontinue
treatment if rash develops. Discontinue treatment if
l BREAST FEEDING Avoid—present in milk in animal studies.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment (risk of increased plasma
Dose adjustments Manufacturer advises dose reduction of
l RENAL IMPAIRMENT Use with caution—limited
l PRE-TREATMENT SCREENING ECG required before
l MONITORING REQUIREMENTS Monitor blood pressure and
heart rate in hypertensive patients.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
Modafinil 100 mg Modafinil 100mg tablets | 30 tablet P £52.60
Modafinil 200 mg Modafinil 200mg tablets | 30 tablet P £105.21 DT = £7.35
Modafinil 100 mg Provigil 100mg tablets | 30 tablet P £52.60
Substance dependence 08-Apr-2018
Guidance on treatment of drug misuse
The UK health departments have produced guidance on the
treatment of drug misuse in the UK. Drug Misuse and
Dependence: UK Guidelines on Clinical Management (2017) is
See Alcohol dependence p. 494.
The management of opioid dependence requires medical,
social, and psychological treatment; access to a
multidisciplinary team is recommended. Treatment for
opioid dependence should be initiated under the supervision
of an appropriately qualified prescriber.
Untreated heroin dependence shows early withdrawal
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