title: Evaluation of sleep, puberty and mental health in children with long-term melatonin treatment for chronic idiopathic childhood sleep onset insomnia.
abstract: OBJECTIVE
  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.
authors.affiliation: Faculty of Veterinary Medicine, Pharmacy Department, Utrecht University, Yalelaan 106, 3584, CM, Utrecht, The Netherlands. i.m.vangeijlswijk@uu.nl
authors.forename: Ingeborg M
authors.initials: IM
authors.lastname: van Geijlswijk
authors.forename: Robert H
authors.initials: RH
authors.lastname: Mol
authors.forename: Toine C G
authors.initials: TC
authors.lastname: Egberts
authors.forename: Marcel G
authors.initials: MG
authors.lastname: Smits
mesh_terms: D000293:Adolescent; D002492:Central Nervous System Depressants / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008550:Melatonin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008603:Mental Health; D009426:Netherlands; D011627:Puberty / Q000187:drug effects*; D012890:Sleep / Q000187:drug effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D011795:Surveys and Questionnaires; D013997:Time Factors
chemical_list: D002492:Central Nervous System Depressants; D008550:Melatonin