ASD

In a study of children who failed to improve on behavioural intervention alone, immediate release (IR) melatonin demonstrated beneficial effects on sleep latency (time to fall asleep) and, to a lesser extent, on total sleep time.

The authors concluded, however, that children gained little additional sleep when taking immediate release melatonin since although they fell asleep significantly faster, waking times were earlier (phase shifting). Child behaviour and family functioning outcomes did not significantly improve.¹⁶ Licensed and unlicensed liquid formulations 
of melatonin are also available; however, these are all immediate release, typically contain additives and preservatives, and require a willing patient for their effective administration. Moreover, unregulated melatonin preparations, or food supplements, are used despite concerns over their provenance, quality, potential safety hazards and lack of evidence for long-term efficacy and safety. Other medications are used outside of licence including antihistamines, alpha-adrenergic agonists (clonidine), antidepressants, and antipsychotics, for their sedative side effects, but in absence of proven safety or efficacy.⁶