An analysis of pediatric melatonin granule usage using receipt data

Abstract

  Objective: Since the launch of melatonin granules, it has been widely prescribed to patients other than those with neurodevelopmental disorders aged 6-15 years, for whom clinical trials have been conducted. The use of melatonin granules was investigated using receipt data after its launch for children. Methods: Using data from 470 Diagnosis Procedure Combination facilities and 144 health insurance societies, from June 2020 to September 2022, we extracted the following information about patients who were prescribed melatonin granules : the number of prescriptions, patient age, disease name, prescription dose. Results: A total of 8235 patients were prescribed melatonin granules, including 4533 males and 3702 females. The median patient age was 11 years. Of these, 6222 patients (75.6%) were aged 6-15 years, and 2013 patients (24.4%) were in the age group, for which safety and efficacy of the granules had not been confirmed. Of the 8235 patients, 4064 patients (49.4%) had autism spectrum disorder, 2331 patients (28.3%) had ADHD, 938 patients (11.4%) had intellectual ability disorder, 508 patients (6.2%) had motor disorders, 431 patients (5.2%) had communication disorders, 192 patients (2.3%) had focal learning syndrome, 1313 patients (15.9%) had other neurodevelopmental disorders, and 1536 patients (18.7%) had non-neurodevelopmental childhood disorders. Their minimum and maximum ages were 0 and 68 years, respectively. The minimum prescribed dose was as low as 0.5 mg, and the maximum prescribed dose was 7-9 mg. Conclusions: Melatonin granules were often prescribed to patients other than those with neurodevelopmental disorders aged 6-15 years. If we can examine the efficacy of melatonin granules in different patients with different insomnia symptoms, we can propose more detailed dosage and administration.