Melatonin treatment in individuals with intellectual disability and chronic insomnia: A randomized placebo-controlled study

Journal of Intellectual Disability Research

Volumn 52, Issue 3, 2008, Pages 256-264

  Braam, Wiebe ^a,c   Didden, R ^b   Smits, M ^c   Curfs, L ^d  

^a 's Heeren Loo Zuid Wekerom   (Netherlands)

^b RADBOUD UNIVERSITY NIJMEGEN   (Netherlands)

^c GELDERSE VALLEI HOSPITAL   (Netherlands)

^d MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Intellectual disability; Melatonin; Randomizedstudy; Sleep problems

Indexed keywords

ANTICONVULSIVE AGENT; MELATONIN; PLACEBO;

ADOLESCENT; ADULT; AROUSAL; ARTICLE; AUTISM; BARDET BIEDL SYNDROME; CAREGIVER; CEREBRAL PALSY; CHILD; CLINICAL TRIAL; CONGENITAL HYPOTHYROIDISM; CONGENITAL RUBELLA SYNDROME; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRYING; DECREASED APPETITE; DISEASE DURATION; DOUBLE BLIND PROCEDURE; DOWN SYNDROME; DRUG EFFICACY; EPILEPSY; FEMALE; FOLLOW UP; HAPPY PUPPET SYNDROME; HUMAN; HYDROCEPHALUS; HYPOPITUITARISM; INSOMNIA; INTELLECTUAL IMPAIRMENT; MAJOR CLINICAL STUDY; MALE; PARENTAL BEHAVIOR; PRADER WILLI SYNDROME; RANDOMIZED CONTROLLED TRIAL; RESTLESS LEGS SYNDROME; RESTLESSNESS; SANFILIPPO SYNDROME; SIDE EFFECT; SLEEP DISORDER; SLEEP TIME; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; CENTRAL NERVOUS SYSTEM DEPRESSANTS; CHILD; CHILD, PRESCHOOL; CHRONIC DISEASE; COMORBIDITY; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MELATONIN; MENTAL RETARDATION; MIDDLE AGED; SALIVA; SLEEP INITIATION AND MAINTENANCE DISORDERS; TIME FACTORS; TREATMENT OUTCOME;

EID: 39049162752     PISSN: 09642633     EISSN: 13652788     Source Type: Journal    
DOI: 10.1111/j.1365-2788.2007.01016.x     Document Type: Article

References (49)

1. Ancoli-israel S., Cole R., Alessi C., Chambers M., Moorcroft W. & Pollak C. P. (2003) The role of actigraphy in the study of sleep and circadian rhythms. Sleep 26, 342-92.
2. Arendt J. (2006) Does melatonin improve sleep? Efficacy of melatonin. British Medical Journal 332, 550.
3. Bartlett L. B., Rooney V. & Spedding S. (1985) Nocturnal difficulties in a population of mentally handicapped children. British Journal of Mental Subnormality 31, 54-9.
4. Bohmer C., Niezen-de Boer M., Klinkenberg-Knol E., Deville W., Nadorp J. & Meuwissen S. (1999) The prevalence of gastroesophageal reflux disease in institutionalised intellectually disabled individuals. American Journal of Gastroenterology 94, 804-10.
5. Bojkowski C., Aldhous M., English J., Franey C., Poulton A., Skene D. et al. (1987) Suppression of nocturnal plasma melatonin and 6-sulphatoxymelatonin by bright and dim light in man. Hormone and Metabolic Research 19, 437-40.
6. Camfield P., Gordon K., Dooley J. & Camfield C. (1996) Melatonin appears ineffective in children with intellectual deficits and fragmented sleep: Six 'N of 1'trials. Journal of Child Neurology 11, 341-3.
7. Claustrat B., Brun J. & Chazot G. (2005) The basic physiology and pathophysiology of melatonin. Sleep Medicine Reviews 9, 11-24.
8. Clements J., Wing L. & Dunn G. (1986) Sleep problems in handicapped children: A preliminary study. Journal of Child Psychology and Psychiatry 27, 399-406.
9. Committee for Proprietary Medicinal Products (1997) Note for Guidance on Clinical Investigation of Medicinal Products in Children, CPMP/EWP/462/ 95. ICH, London.
10. Coppola G., Iervolino G., Mastrosimone M., La Torre G., Ruiu F. & Pascotto A. (2004) Melatonin in wake-sleep disorders in children, adolescents and young adults with mental retardation with or without epilepsy: A double-blind, cross-over, placebo-controlled trial. Brain and Development 26, 373-6.
11. Dahlitz M., Alvarez B., Vignau J., English J., Arendt J. & Parkes J. (1991) Delayed sleep phase syndrome response to melatonin. Lancet 337, 1121-4.
12. De Leersnijder H., Bresson J. L., de Blois M.-C., Souberbielle J.-C., Mogenet A., Delhotal-Landes B. et al. (2003) β1-adrenergic antagonists and melatonin reset the clock and restore sleep in a circadian disorder, Smith-Magenis syndrome. Journal of Medical Genetics 40, 74-8.
13. De Miguel-Diez J., Villa-Asensi J. R. & Alvarez-Sala J. L. (2003) Prevalence of sleep-disordered breathing in children with Down syndrome: polygraphic findings in 108 children. Sleep 26, 1006-9.
14. Didden R., Korzilius H., van Aperlo B., van Overloop C. & de Vries M. (2002) Sleep problems and daytime problem behaviours in children with intellectual disability. Journal of Intellectual Disability Research 46, 537-47.
15. Dodge N. N. & Wilson G. A. (2001) Melatonin for treatment of sleep disorders in children with developmental disabilities. Journal of Child Neurology 16, 581-4.
16. Doran S., Harvey M. & Horner R. (2006) Sleep and developmental disabilities: Assessment, treatment, and outcome measures. Mental Retardation 44, 13-27.
17. Espie C. A. & Tweedie F. M. (1998) Sleep patterns and sleep problems amongst individuals with mental handicap. Journal of Mental Deficiency Research 35, 25-36.
18. Garstang J. & Wallis M. (2006) Randomized controlled trial of melatonin for children with autistic spectrum disorders and sleep problems. Child: Care, Health and Development 32, 585-9.
19. Ishizaki A., Sugama M. & Takeuchi N. (1999) [Usefulness of melatonin for developmental sleep and emotional/behavior disorders - studies of melatonin trial on 50 patients with developmental disorders]. No To Hattatsu 31, 428-37.
20. Jan J. E. & Freeman R. D. (2004) Melatonin therapy for circadian rhythm sleep disorders in children with multiple disabilities: What have we learned in the last decade? Developmental Medicine and Child Neurology 46, 776-82.
21. Jan M. M. S. (2000) Melatonin for the treatment of handicapped children with severe sleep disorders. Pediatric Neurology 23, 229-32.
22. Kraijer D. & Kema G. N. (1994) SRZ, Sociale Redzaamheidsschaal voor Zwakzinnigen. Handleiding (Social Functioning Scale for the Mentally Retarded, 5th ed.). Lisse: Swets & Zeitlinger.
23. Kunz D., Mahlberg R., Müller C., Tilmann A. & Bes F. (2004) Melatonin in patients with reduced REM sleep duration: Two randomized trials. Journal of Clinical Endocrinology and Metabolism 89, 128-34.
24. Lewy A. J., Ahmed S., Jackson J. M. & Sack R. L. (1992) Melatonin shifts human circadian rhythms according to a phase-response curve. Chronobiology International 9, 380-92.
25. McArthur A. J. & Budden S. S. (1998) Sleep dysfunction in Rett syndrome: A trial of exogenous melatonin treatment. Developmental Medicine & Child Neurology 40, 186-92.
26. Matson J. L., Bamburg J. W., Mayville E. A., Pinkston J., Bielecki J., Kuhn D. et al. (2000) Psychopharmacology and mental retardation: A 10 year review (1990-1999). Research in Developmental Disabilities 21, 263-96.
27. Miano S., Bruni O., Elia M., Musumeci S., Verrillo E. & Ferri R. (2005) Sleep breathing and periodic leg movement pattern in Angelman syndrome: A polysomnographic study. Clinical Neurophysiology 116, 2685-92.
28. Miyamoto A., Oki J., Takahashi S. & Okuno A. (1999) Serum melatonin kinetics and long-term melatonin treatment for sleep disorders in Rett syndrome. Brain and Development 21, 59-62.
29. Montgomery P., Stores G. & Wiggs L. (2004) The relative efficacy of two brief treatments for sleep problems in young learning disabled (mentally retarded) children: A randomised controlled trial. Archives of Disease in Childhood 89, 125-30.
30. Nagtegaal E., Peeters T., Swart W., Smits M., Kerkhof G. & van der Meer G. (1998b) Correlation between concentrations of melatonin in saliva and serum in patients with delayed sleep phase syndrome. Therapeutic Drug Monitoring 20, 181-3.
31. Nagtegaal J., Kerkhof G., Smits M., Swart A. & van der Meer Y. (1998a) Delayed sleep phase syndrome: A placebo-controlled cross-over study on the effects of melatonin administered five hours before the individual dim light melatonin onset. Journal of Sleep Research 7, 135-43.
32. Niederhofer H., Staffen W., Mair A. & Pittschieler K. (2003) Brief report: Melatonin fascilitates sleep in individuals with mental retardation and insomnia. Journal of Autism and Developmental Disorders 33, 469-72.
33. O'Callaghan F. J. K., Clarke A. A., Hancock E., Hunt A. & Osborne J. P. (1999) Use of melatonin to treat sleep disorders in tuberous sclerosis. Developmental Medicine and Child Neurology 41, 123-6.
34. Palm L., Blennow G. & Wetterberg L. (1997) Long-term melatonin treatment in blind children and young adults with circadian sleep-wake disturbances. Developmental Medicine and Child Neurology 39, 319-25.
35. Piazza C., Fisher W. & Kahng S. (1996) Sleep patterns in children and young adults with mental retardation and severe behavior disorders. Developmental Medicine and Child Neurology 38, 335-44.
36. Pillar G., Shahar E., Peled N., Ravid S., Lavie P. & Etzioni A. (2000) Melatonin improves sleep-wake patterns in psychomotor retarded children. Pediatric Neurology 23, 225-8.
37. Quine L. (1991) Sleep problems in children with mental handicap. Journal of Mental Deficiency Research 35, 269-90.
38. Ramstad K. & Loge J. (2002) Melatoninbehandling ved sovnforstyrrelser hos funksjonshemmede barn. Tidsskrift Norske Laegeforening 122, 1009-11.
39. Ross C., Davies P. & Whitehouse W. (2002) Melatonin treatment for sleep disorders in children with neurodevelopmental disorders: An observational study. Developmental Medicine and Child Neurology 44, 339-44.
40. Ruger M., Gordijn M., Beersma D., de Vries B. & Daan S. (2003) Acute and phase-shifting effects of ocular and extraocular light in human circadian physiology. Journal of Biological Rhythms 18, 409-19.
41. Sadeh A., Lavie P., Scher A., Tirosh E. & Epstein R. (1991) Actigraphic home-monitoring sleep-disturbed and control infants and young children: A new method for pediatric assessment of sleep-wake patterns. Pediatrics 87, 494-9.
42. Sheldon S. (1998) Pro-convulsant effects of oral melatonin in neurologically disabled children. Lancet 351, 1254.
43. Simon G. E. & VonKorff M. (1997) Prevalence, burden, and treatment of insomnia in primary care. American Journal of Psychiatry 154, 1417-23.
44. Smits M., van Stel H., Nagtegaal J., van der Heijden J., Coenen A. & Kerkhof G. (2001) Melatonin for chronic sleep onset insomnia in children: A randomized placebo-controlled trial. Journal of Child Neurology 16, 86-92.
45. Smits M., van Stel H., van der Heijden K., Meijer A., Coenen A. & Kerkhof G. (2003) Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: A randomized placebo-controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry 42, 1286-93.
46. Van der Heijden K. B., Smits M. G., Van Someren E. J. & Gunning W. B. (2005) Prediction of melatonin efficacy by pre-treatment dim light melatonin onset in children with idiopathic chronic sleep onset insomnia. Journal of Sleep Research 14, 187-94.
47. Wieringen S. van Jansen T., Smits M., Nagtegaal J. & Coenen A. (2001) Melatonin for chronic whiplash syndrome with delayed melatonin onset. Randomised, placebo-controlled trial. Clinical Drug Investigation 21, 813-20.
48. Wirz-Justice A. & Armstrong S. (1996) Melatonin: Nature's soporific? Journal of Sleep Research 5, 137-41.
49. Zhdanova I. V., Wurtman R. J. & Wagstaff J. (1999) Effects of low dose of melatonin on sleep in children with Angelman syndrome. Journal of Pediatric Endocrinology and Metabolism 12, 57-67.