Off-Label Prescribing of Psychotropic Medications in Pediatric Populations 12/5/19

The optimal approach in medicine is to aim for evidence-based treatments that provide reasonable assurance of efficacy and effectiveness along with meaningful evidence of limited potential for serious side effect risk.   With both adult populations but more especially with children and adolescents, there are clinical situations where use of medications that are not FDA approved may be warranted and a considerable amount of prescribing practice is done “off-label”, where a medication is used for a non-FDA approved clinical indication, or is used outside of the designated dosage ranges, age status or duration of treatment in the underlying FDA database.

The practice of off-label prescribing is fully appropriate if guided by long term clinical practice and experience or, in the case of children/youth, by extrapolation based upon studies with adults.   There are many clinical situations where such off-label prescribing is warranted1, but this should be done with particular attention to both general developmental and to pharmacodynamic and pharmacokinetic differences in different aged populations.

In pediatric psychiatry there is far less of an evidence base to support many common prescribing practices than there is with adult psychiatry—this is true for many first line treatment options and more particularly the case for second line or third line agents2  It is also particularly true for older “grandfathered” medications that have been in use for longer periods of time.

Following are some examples of medications used as off-label agents that are more commonly used with adults but may be of value in treating adolescents and, in some cases children.

Trazodone:   This medication has been FDA approved since the early 1980’s for depression in adults but it has never been approved for use in any population for insomnia, though this is far and away its most common use with adults and sometimes with older adolescents.  Historically, it has also been used in low dosing as an agent for treating aggressive behaviors in youth.

Quetiapine (Seroquel):   Far less likely to be ascribed as “safe” because of metabolic side effects and potential induction of movement disorders, quetiapine is not infrequently prescribed for insomnia and agitation and may be used in lower doses for managing anxiety.

Diphenhydramine and Melatonin, both available over the counter, are other agents targeting sleep problems, again without FDA approved status—both are widely used and though they do not always provide therapeutic benefit, some patients find them useful.

Informed consent activities when prescribing medication “off label” should include reference the “off label” (i.e., not FDA approved) status of the medication being prescribed with an explanation that doing so meets clinical standards of care.

In summary, “off label” prescribing is common and acceptable in the behavioral health arena as many DSM 5 diagnoses have no FDA approved medication1 and a significant part of pediatric prescribing is focused on various relevant target symptoms that may be ameliorated with appropriately chosen medications.


1     “BAP Position Statement: Off-Label prescribing of psychotropic medication to children and adolescents”, Current Psychiatry. 2012 July; 11 (7): 23-27

2   “National Patterns of Commonly Prescribed Psychotropic Medications to Young People”, Current Psychiatry. 2019 September: 18, (9): 27-36

3     “When is off-label prescribing appropriate”, J Psychopharmacology. 2016 May; 30 (5)


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