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Clinical Trial
. 2011 Jul;216(1):111-20.
doi: 10.1007/s00213-011-2202-y. Epub 2011 Feb 22.

Evaluation of Sleep, Puberty and Mental Health in Children With Long-Term Melatonin Treatment for Chronic Idiopathic Childhood Sleep Onset Insomnia

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Free PMC article
Clinical Trial

Evaluation of Sleep, Puberty and Mental Health in Children With Long-Term Melatonin Treatment for Chronic Idiopathic Childhood Sleep Onset Insomnia

Ingeborg M van Geijlswijk et al. Psychopharmacology (Berl). .
Free PMC article

Abstract

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.

Figures

Fig. 1
Fig. 1
Justification of obtained outcome data
Fig. 2
Fig. 2
Pubertal development: stage line diagram with SDS plot for girls (n = 30). This figure depicts the SDS values for development of breast (blue lines, five stages), pubic hair (green lines, five stages) and menarche (red lines, yes or no) of 30 girls. The black circles depict the three SDS values for three individual girls, the first circle represents a girl with an early menarche and nearly p90 values for breast and pubic hair, the middle circle represents a girl with p50 development, and the third circle represents a girl with normal menarche but late breast development
Fig. 3
Fig. 3
Pubertal development; stage line diagram with SDS plot for boys (n = 15). This figure depicts the SDS values for development of genitals (blue lines, five stages), pubic hair (green lines, five stages) and testis (red lines, eight volumes) of 15 boys. The black circles depict the three SDS values for three individual boys, the first circle represents a boy with an early development, almost p99 values for all parameters, the middle circle represents a boy with p50 development, and the third circle represents a boy with late development of all parameters (p5)

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