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Background: Melatonin is commonly used to treat sleep disturbance in children and adolescents, although uncertainties about its optimal use remain., Objective: To determine to what extent prescribing of melatonin complies with evidence-based clinical practice standards., Methods: As part of a quality improvement programme, the Prescribing Observatory for Mental Health conducted a retrospective clinical audit in UK services for children and adolescents., Findings: Data were submitted for 4151 children and adolescents up to 18 years of age, treated with melatonin: 3053 (74%) had a diagnosis of neurodevelopmental disorder. In 2655 (73%) of the 3651 patients prescribed melatonin to be taken regularly, the main reason was to reduce sleep latency (time taken to fall asleep). In 409 patients recently starting melatonin, a non-pharmacological intervention had already been tried in 279 (68%). The therapeutic response of patients early in treatment (n=899) and on long-term treatment (n=2353) had been assessed and quantified in 36% and 31%, respectively, while for review of side effects, the respective proportions were 46% and 43%. Planned treatment breaks were documented in 317 (13%) of those on long-term treatment., Conclusions: Melatonin was predominantly prescribed for evidence-based clinical indications, but the clinical review and monitoring of this treatment fell short of best practice., Clinical Implications: With limited methodical review of melatonin use in their patients, clinicians will fail to garner reliable information on its risks and benefits for individual patients. The lack of such practice-based evidence may increase the risk of melatonin being inappropriately targeted or continued despite being ineffective or no longer indicated., Competing Interests: Competing interests: CP, OR, AR, GB and TREB have no interests to declare. PG was CI on the NIHR investigator-led Mends RCT melatonin trial and the Neurim industry-led international RCT for Slenyto melatonin; reports participation in advisory panels for AGB, Flynn Pharma and Alturix; but reports no shares or ongoing work with any of the above. AL reports speaking and travel honoraria from Takeda and Flynn Pharma., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. Published by BMJ.)