Evaluation of sleep, puberty and mental health in children with long-term melatonin treatment for chronic idiopathic childhood sleep onset insomnia.
Study Goal
The researchers aimed to determine whether long-term melatonin use affects pubertal development, sleep quality, and mental health in children compared to the general Dutch population.
Results Summary
The study found no statistically significant differences in sleep quality, puberty development, or mental health scores between melatonin-treated children and the general Dutch population. Long-term melatonin use (mean 3.1 years) was well-tolerated without substantial developmental deviations.
Population
Dutch children previously enrolled in a melatonin dose-finding trial.
Effective Dosage
Mean dose 2.69 mg (range 0.3–10 mg).
Duration
Mean 3.1 years (range 1.0–4.6 years).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin treatment | no change | SDQ score | children | no significant change | did not differ in a statistically significant way | #1 |
melatonin treatment | no change | CSHQ score | children | no significant change | did not differ in a statistically significant way | #2 |
melatonin treatment | no change | Tanner Stages standard deviation scores | children | no significant change | did not differ in a statistically significant way | #3 |
melatonin treatment | no change | development of children with respect to sleep quality, puberty development and mental health scores | children | without substantial deviation | can be sustained over a long period of time without substantial deviation | #4 |
OBJECTIVES: To establish whether long-term use of melatonin influences pubertal development, sleep quality and mental health development in children as compared with the normal Dutch population of the same age. METHODS: This follow-up research study was conducted in children included in a previous melatonin dose-finding trial. Outcomes were measured using questionnaires (Strength and Difficulties Questionnaire (SDQ), Children's Sleep Habits Questionnaire (CSHQ) and Tanner Stages) adopted for Dutch children. Mean duration of therapy, persistence of effect, adverse events and (other) reasons leading to cessation of therapy were additional objectives of this study. RESULTS: Mean years of usage (n=51) was 3.1 years (min 1.0 year, max 4.6 years), mean dose 2.69 mg (min 0.3 mg, max 10 mg). Mean SDQ score, mean CSHQ score and Tanner Stages standard deviation scores did not differ in a statistically significant way from published scores of the general Dutch population of the same age and sex. CONCLUSIONS: This follow-up study demonstrates that melatonin treatment in children can be sustained over a long period of time without substantial deviation of the development of children with respect to sleep quality, puberty development and mental health scores, as compared with the general Dutch population.