Melatonin
lINDICATIONS 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 daylUNLICENSED USENot licensed for use in children.
lCAUTIONSAutoimmune disease (manufacturer advises
avoid—no information available)
lINTERACTIONS→Appendix 1 : melatonin
lSIDE-EFFECTS
▶Common or very commonArthralgia.headaches.increased
risk of infection.pain
▶UncommonAnxiety.asthenia.chest pain.dizziness.
drowsiness.dry mouth.gastrointestinal discomfort.
hyperbilirubinaemia.hypertension.menopausal
symptoms.mood altered.movement disorders.nausea.
night sweats.oral disorders.skin reactions.sleep
disorders.urine abnormalities.weight increased
▶Rare or very rareAggression.angina pectoris.arthritis.
concentration impaired.crying.depression.
disorientation.electrolyte imbalance.excessive tearing.
gastrointestinal disorders.haematuria.hotflush.
hypertriglyceridaemia.leucopenia.memory loss.muscle
complaints.nail disorder.palpitations.paraesthesia.
partial complex seizure.prostatitis.sexual dysfunction.
syncope.thirst.thrombocytopenia.urinary disorders.
vertigo.vision disorders.vomiting
▶Frequency not knownAngioedema.galactorrhoea
lPREGNANCYNo information available—avoid.
lBREAST FEEDINGPresent in milk—avoid.
lHEPATIC IMPAIRMENTClearance reduced—avoid.
lRENAL IMPAIRMENTNo information available—use with
caution.
lPRESCRIBING AND DISPENSING INFORMATIONTreatment
with melatonin should be initiated and supervised by a
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 also as unlicensed formulations.Circadin®
is licensed for the short-term treatment of primary
insomnia in adults over 55 years. 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.
lPATIENT AND CARER ADVICE
Medicines for Children leaflet: Melatonin for sleep problems
http://www.medicinesforchildren.org.uk/melatonin-for-sleep-
disorders
lMEDICINAL 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 LABELS2, 21, 25
▶Melatonin (Non-proprietary)
Melatonin 3 mgMelatonin 3 mg modified-release tablets|
120 tabletPs
▶Circadin(Flynn Pharma Ltd)
Melatonin 2 mgCircadin 2 mg modified-release tablets|
30 tabletP£ 15. 39 DT = £ 15. 39
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 ( 2007 )is available atwww.nta.nhs.uk/
uploads/clinical_guidelines_ 2007 .pdf.Nicotine dependence
Smoking cessation interventions are a cost-effective way of
reducing ill health and prolonging life. Smokers should be
advised to stop and offered help with follow-up when
appropriate. If possible, smokers should have access to
smoking cessation services for behavioural support.
Therapy to aid smoking cessation is chosen according to
the smoker’s likely adherence, availability of counselling and
support, previous experience of smoking-cessation aids,
contra-indications and adverse effects of the preparations,
and the smoker’s preferences.Nicotine replacement
therapy p. 296 is an effective aid to smoking cessation. The
use of nicotine replacement therapy in an individual who is
already accustomed to nicotine introduces few new risks and
it is widely accepted that there are no circumstances in
which it is safer to smoke than to use nicotine replacement
therapy.
Some individuals benefit from having more than one type
of nicotine replacement therapy prescribed, such as a
combination of transdermal and oral preparations.
Concomitant medication
Cigarette smoking increases the metabolism of some
medicines by stimulating the hepatic enzyme CYP 1 A 2. When
smoking is discontinued, the dose of these drugs, in
particular theophylline, and some antipsychotics (including
clozapine, olanzapine, chlorpromazine hydrochloride, and
haloperidol) may need to be reduced. Regular monitoring for
adverse effects is advised.Nicotine replacement therapy
Nicotine replacement therapycan be used in place of
cigarettes after abrupt cessation of smoking, or alternatively
to reduce the amount of cigarettes used in advance of
making a quit attempt. Nicotine replacement therapy can
also be used to minimise passive smoking, and to treat
cravings and reduce compensatory smoking after enforced
abstinence in smoke-free environments. Smokers whofind it
difficult to achieve abstinence should consult a healthcare
professional for advice.
Choice
Nicotine patches are a prolonged-release formulation and
are applied for 16 hours (with the patch removed overnight)
or for 24 hours. If the individual experiences strong cravings
for cigarettes on waking, a 24 -hour patch may be more
suitable. Immediate-release nicotine preparations (gum,
lozenges, sublingual tablets, inhalator, nasal spray, and oral
spray) are used whenever the urge to smoke occurs or to
prevent cravings.
The choice of nicotine replacement preparation depends
largely on patient preference, and should take into account
what preparations, if any, have been tried before. Patients
with a high level of nicotine dependence, or who have failed
with nicotine replacement therapy previously, may benefit
from using a combination of an immediate-release
preparation and patches to achieve abstinence.BNFC 2018 – 2019 Substance dependence 295
Nervous system4