# 21 - Examples of acceptable use of drugs outside t

# Examples of acceptable use of drugs outside their licences/labels

Prescribing psychotropics
CHAPTER 14
The advice is largely echoed by more recent publications from the American 
Psychiatric Association17 (who note that off-­label prescribing should be reimbursed) 
and the Royal Australian and New Zealand College of Psychiatrists18 who emphasise 
shared decision-­making and the presumption of capacity.
Examples of acceptable use of drugs outside their licences/labels
Table 14.5 gives examples of common unlicensed uses of drugs in psychiatric practice. 
These examples would all fulfil the Bolam and Bolitho criteria in principle. An exhaustive list of unlicensed uses is impossible to prepare as the evidence base is constantly 
changing and because the expertise and experience of prescribers vary. A particular 
strategy may be justified in the hands of a specialist in psychopharmacology based in a 
tertiary referral centre but be much more difficult to justify if initiated by someone with 
a special interest in psychotherapy who rarely prescribes.
Note that some drugs do not have a UK licence for any indication. Two commonly 
prescribed examples in psychiatric practice are immediate-­release formulations of 
melatonin (used to treat insomnia in children and adolescents) and pirenzepine (used 
to treat clozapine-­induced hypersalivation). Awareness of the evidence base and documentation of potential benefits, adverse effects and patient consent are especially 
important here.
Table 14.5  Examples of common unlicensed uses of drugs in psychiatric practice.
Drug/drug group
Unlicensed use(s)
Further information
Second-­generation 
antipsychotics
Psychotic illness other than 
schizophrenia
Licensed indications vary markedly, and 
in most cases are unlikely to reflect real 
differences in efficacy between drugs.
Clozapine
Bipolar disorder
Substantial evidence to support efficacy 
when standard treatments have failed to 
control symptoms
Cyproheptadine
Akathisia
Some evidence to support efficacy in 
this distressing and difficult to treat 
adverse effect of antipsychotics
Fluoxetine/sertraline
Generalised anxiety disorder
Substantial supporting evidence
Ketamine (racemate)
Refractory depression
Substantial evidence with both racemate 
and S-­isomer
Melatonin (circadin)
Insomnia in children
Licence covers adults >55 years only.
Probably preferable to unlicensed 
formulations of melatonin.
Naltrexone
Self-­injurious behaviour in people 
with learning disabilities
Limited evidence base
Acceptable in specialist hands
Sodium valproate
Treatment and prophylaxis of 
bipolar disorder
Established clinical practice
Evidence from other valproate 
preparations