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 302 Sleep disorders
6 Sleep disorders
6.1 Insomnia
4 l INDICATIONS AND DOSE
Hypnotics and anxiolytics
Nervous system
Overview
Most anxiolytics (‘sedatives’) will induce sleep when given at
night and most hypnotics will sedate when given during the
day. Hypnotics and anxiolytics should be reserved for short
courses to alleviate acute conditions after causal factors have
been established.
The role of drug therapy in the management of anxiety
disorders in children and adolescents is uncertain; drug
therapy should be initiated only by specialists after
psychosocial interventions have failed. Benzodiazepines and
tricyclic antidepressants have been used but adverse effects
may be problematic.
Hypnotics
The prescribing of hypnotics to children, except for
occasional use such as for sedation for procedures is not
justified. There is a risk of habituation with prolonged use.
Problems settling children at night should be managed with
behavioural therapy.
Dental procedures
Some anxious children may benefit from the use of a
hypnotic the night before a dental appointment.
Chloral and derivatives
Chloral hydrate below and derivatives were formerly popular
hypnotics for children. Chloral hydrate is now mainly used
for sedation during diagnostic procedures.
Antihistamines
Some antihistamines such as promethazine hydrochloride
p. 183 are used for occasional insomnia in adults; 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. The use of hypnotics
in children is not usually justified.
Melatonin
Melatonin p. 303 is a pineal hormone that may affect sleep
pattern. Clinical experience suggests that when appropriate
behavioural sleep interventions fail, melatonin may be of
value for treating sleep onset insomnia and delayed sleep
phase syndrome in children with conditions such as visual
impairment, cerebral palsy, autism, and learning difficulties.
It is also sometimes used before magnetic resonance imaging
(MRI), computed tomography (CT), or EEG investigations.
Little is known about its long-term effects in children, and
there is uncertainty as to the effect on other circadian
rhythms including endocrine or reproductive hormone
secretion. The need to continue melatonin therapy should be
reviewed every 6 months.
Anxiolytics
Anxiolytic treatment should be used in children only to
relieve acute anxiety (and related insomnia) caused by fear
(e.g. before surgery). Anxiolytic treatment should be limited
to the lowest possible dose for the shortest possible time.
Buspirone
Buspirone hydrochloride is thought to act at specific
serotonin (5HT1A) receptors; safety and efficacy in children
have yet to be determined.
BNFC 2019–2020
HYPNOTICS, SEDATIVES AND ANXIOLYTICS ›
NON-BENZODIAZEPINE
Chloral hydrate 12-Jul-2018
Sedation for painless procedures
▶ BY MOUTH, OR BY RECTUM
▶ Neonate: 30–50 mg/kg, to be given 45–60 minutes
before procedure, doses up to 100 mg/kg may be used
with respiratory monitoring, administration by rectum
only if oral route not available.
▶ Child 1 month–11 years: 30–50 mg/kg (max. per dose 1 g),
to be given 45–60 minutes before procedure,
administration by rectum only if oral route not
available, increased if necessary up to 100 mg/kg (max.
per dose 2 g)
▶ Child 12–17 years: 1–2 g, to be given 45–60 minutes
before procedure, administration by rectum only if oral
route not available
Insomnia (short-term use), using chloral hydrate
143.3 mg/5 mL oral solution
▶ BY MOUTH USING ORAL SOLUTION
▶ Child 2–11 years: 30–50 mg/kg once daily (max. per dose
1 g), dose to be taken with water or milk at bedtime
▶ Child 12–17 years: 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
▶ BY MOUTH USING TABLETS
▶ Child 12–17 years: 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 UNLICENSED USE Not licensed for sedation for painless
procedures.
l CONTRA-INDICATIONS Acute porphyrias p. 624 . 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
l INTERACTIONS → Appendix 1: chloral hydrate
l SIDE-EFFECTS Agitation . allergic dermatitis . ataxia .
confusion . delirium (more common on abrupt
discontinuation) . drug use disorders . gastrointestinal
discomfort . gastrointestinal disorders . headache . injury .
ketonuria . kidney injury
l PREGNANCY Avoid.
l BREAST FEEDING Risk of sedation in infant—avoid.
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
marked impairment.
l RENAL IMPAIRMENT Avoid in severe impairment.
l DIRECTIONS FOR ADMINISTRATION
▶ With oral use For administration by mouth dilute liquid with
plenty of water or juice to mask unpleasant taste.
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include black currant.
The RCPCH and NPPG recommend that, when a liquid
special of chloral hydrate is required, the following
strength is used: 1 g/5 mL.
l PATIENT AND CARER ADVICE
Driving and skilled tasks Drowsiness may persist the next
day and affect performance of skilled tasks (e.g. driving);
effects of alcohol enhanced.
 BNFC 2019–2020
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
solution, suppository, enema
Tablet
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
Oral solution
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
Melatonin 22-May-2019
l INDICATIONS AND DOSE
Sleep onset insomnia (initiated under specialist
supervision) | Delayed sleep phase syndrome (initiated
under specialist supervision)
▶ BY MOUTH USING MODIFIED-RELEASE TABLETS
▶ Child: Initially 2–3 mg daily for 1–2 weeks, then
increased if necessary to 4–6 mg daily, dose to be taken
before bedtime; maximum 10 mg per day
SLENYTO ®
Insomnia with autism spectrum disorder [where sleep
hygiene measures have been insufficient] | Insomnia
with Smith-Magenis syndrome [where sleep hygiene
measures have been insufficient]
▶ BY MOUTH USING MODIFIED-RELEASE TABLETS
▶ Child 2–17 years: Initially 2 mg once dailyIncreased if
necessary to 5 mg once daily, dose to be taken
30–60 minutes before bedtime; maximum 10 mg per
day
l UNLICENSED USE Melatonin is used for sleep onset
insomnia and delayed sleep phase syndrome, but is not
licensed for these indications.
l CAUTIONS Autoimmune disease (manufacturer advises
avoid—no information available)
l INTERACTIONS → Appendix 1: melatonin
l SIDE-EFFECTS
▶ Common or very common Arthralgia . behaviour abnormal .
drowsiness . feeling abnormal . headaches . increased risk
of infection . mood altered . pain . sleep disorders
▶ Uncommon Anxiety . asthenia . chest pain . dizziness . dry
mouth . gastrointestinal discomfort . hyperbilirubinaemia .
hypertension . menopausal symptoms . movement
disorders . nausea . night sweats . oral disorders . skin
reactions . urine abnormalities . weight increased
▶ Rare or very rare Angina pectoris . arthritis . concentration
impaired . crying . depression . disorientation . electrolyte
imbalance . excessive tearing . gastrointestinal disorders .
haemorrhage . hot flush . hypertriglyceridaemia .
leucopenia . memory loss . muscle complaints . nail
disorder . palpitations . paraesthesia . prostatitis . seizures .
sexual dysfunction . syncope . thirst . thrombocytopenia .
urinary disorders . vertigo . vision disorders . vomiting
▶ Frequency not known Angioedema . appetite decreased .
constipation . dyspnoea . galactorrhoea . neutropenia
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
caution.
l PRESCRIBING AND DISPENSING INFORMATION Treatment
with melatonin should be initiated and supervised by a
Substance dependence 303
specialist, but may be continued by general practitioners.
The need to continue melatonin therapy should be
reviewed every 6 months.
Melatonin is available as a modified-release tablet
(Circadin ® and Slenyto ®) and also as unlicensed
formulations. Circadin ® is licensed for the short-term 4
treatment of primary insomnia in adults over 55 years.
Nervous system
Unlicensed immediate-release preparations are available,
however, there is variability in clinical effect of unlicensed
formulations.
The RCPCH and NPPG recommend that, when a liquid
special of melatonin is required, the following strength is
used: 1 mg/mL.
l PATIENT AND CARER ADVICE
Medicines for Children leaflet: Melatonin for sleep disorders
www.medicinesforchildren.org.uk/melatonin-sleep-disorders
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
tablet
Modified-release tablet
CAUTIONARY AND ADVISORY LABELS 2, 21, 25
▶ Melatonin (Non-proprietary)
Melatonin 3 mg Melatonin 3mg modified-release tablets |
120 tablet P s
▶ Circadin (Flynn Pharma Ltd)
Melatonin 2 mg Circadin 2mg modified-release tablets |
30 tablet P £15.39 DT = £15.39
▶ Slenyto (Flynn Pharma Ltd)
Melatonin 1 mg Slenyto 1mg modified-release tablets |
60 tablet P £41.20
Melatonin 5 mg Slenyto 5mg modified-release tablets |
30 tablet P £103.00
7 Substance dependence
Substance dependence
Guidance on treatment of drug misuse
Treatment of alcohol or opioid dependence in children
requires specialist management. 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 available at www.gov.uk/
government/publications/drug-misuse-and-dependence-uk-
guidelines-on-clinical-management.
Nicotine dependence
See Smoking cessation p. 304.
Neonatal abstinence syndrome
Neonatal abstinence syndrome occurs at birth as a result of
intra-uterine exposure to opioids or high-dose
benzodiazepines. Treatment is usually initiated if:
. feeding becomes a problem and tube feeding is required;
. there is profuse vomiting or watery diarrhoea;
. the baby remains very unsettled after two consecutive
feeds despite gentle swaddling and the use of a pacifier.
Treatment involves weaning the baby from the drug on
which it is dependent. Morphine p. 290 or methadone
hydrochloride p. 307 can be used in babies of mothers who
have been taking opioids. Morphine p. 290 is widely used
because the dose can be easily adjusted, but methadone
hydrochloride p. 307 may provide smoother control of
symptoms. Weaning babies from opioids usually takes
7–10 days.
Weaning babies from benzodiazepines that have a long
half-life is difficult to manage; chlorpromazine
hydrochloride p. 251 may be used in these situations but