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Melatonin usage in children and young adults, a registry-based cohort study
K Tedroff1, M von Euler2, E Dahlén3
1Department of Women's and Children's Health, Karolinska Institutet, SE, 171 76, Stockholm, Sweden; Region Stockholm, Health and Medical Care Administration, Box 6909, SE, 102 39, Stockholm, Sweden; Centre for Psychiatry Research, Stockholm Health Care Services, Region Stockholm, 113 30, Stockholm, Sweden.
Insights
Melatonin use is rising in children and adolescents, especially those with ADHD or ASD. Long-term safety data is lacking, raising concerns about continuous melatonin use in this population.
Area of Science:
- Pediatrics
- Pharmacology
- Neuroscience
Background:
- Sleep disorders are prevalent in children and adolescents, often co-occurring with neurodevelopmental conditions like attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD).
- While non-pharmacological interventions are primary, pharmacological options, including melatonin, are sometimes necessary.
- Melatonin, an endogenous hormone, is increasingly prescribed for pediatric sleep disturbances.
Purpose of the Study:
- To analyze the real-world dispensation patterns of melatonin in young individuals (0-25 years) in Stockholm, Sweden, from 2016-2019.
- To investigate the diagnostic context and co-medication associated with melatonin use.
- To assess the continuity and duration of melatonin treatment in this cohort.
Main Methods:
- A registry-based cohort study utilizing dispensation data from 2016-2019.
- Inclusion of 9980 individuals aged 0-25 years who received melatonin in 2016.
- Follow-up for 3 years to track prescription patterns and co-morbidities.
Main Results:
- Child psychiatrists were the most frequent prescribers (55%).
- Only 20% of individuals had a recorded sleep disorder diagnosis; 65% had a neuropsychiatric diagnosis.
- Half the cohort received melatonin continuously, with dose and volume increases; continuous use was highest in 6-12 year olds (70% adherence after 3 years).
Conclusions:
- The study highlights a significant trend of continuous melatonin use in children and adolescents, often without a primary sleep disorder diagnosis.
- The lack of long-term safety data for pediatric melatonin use is concerning.
- There is a critical need for robust long-term follow-up and safety monitoring of melatonin treatment in young individuals.
Abstract:
Sleep disorder is common in children and adolescents, particularly in those with attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD). While non-pharmacological treatment is first line, occasionally an add-on of an oral drug is needed. The endogenous hormone melatonin is increasingly used for sleep disorders in children and adolescents. In this registry-based cohort study we follow dispensation of melatonin in young individuals, 0-25 years of age, in Stockholm, Sweden during 2016-2019. In all 9980 individuals, were dispensed melatonin in 2016 and followed for 3 years. Child psychiatrist was the most common prescribing specialty, 55% of all prescriptions. Only 20% had a recorded diagnosis of sleep disorder. The majority, 65% had a neuro psychiatric diagnose. Half of the individuals had at least 4 prescribed drugs dispensed during the follow-up. Almost half of our cohort were dispensed melatonin during the entire study period and doses and volumes of drug dispensed increased by 50 and 100%, respectively. Continuous medication was most common among children 6-12 years, where 7 out of 10 individuals were still adherent after three years. As long-term safety data is lacking, we find this concerning, and this illustrates the need of long-term follow-up of melatonin use in children and young individuals.
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