Clinical trials of controlled-release melatonin in children with sleep-wake cycle disorders

Journal of Pineal Research

Volumn 29, Issue 1, 2000, Pages 34-39

  Jan, James E ^a   Hamilton, Don ^c   Seward, Nadine ^c   Fast, Diane K ^a   Freeman, Roger D ^a   Laudon, Moshe ^b  

^a BC CHILDREN S HOSPITAL   (Canada)

^b NEURIM PHARMACEUTICALS LTD   (Israel)

^c NONE

Author keywords

Children; Controlled release melatonin; Melatonin; Multidisabled; Sleep disturbance

Indexed keywords

MELATONIN;

ADOLESCENT; ARTICLE; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEVELOPMENTAL DISORDER; DISABLED PERSON; DOSE CALCULATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG RELEASE; HUMAN; NERVOUS SYSTEM DEVELOPMENT; RANDOMIZED CONTROLLED TRIAL; SLEEP DISORDER; SLEEP WAKING CYCLE;

EID: 0005130439     PISSN: 07423098     EISSN: None     Source Type: Journal    
DOI: 10.1034/j.1600-079X.2000.290105.x     Document Type: Article

References (31)

1. ALDHOUS, M., C. FRANEY, J. WRIGHT, J. ARENDT (1985) Plasma concentrations of melatonin in man following oral absorption of different preparations. Br. J. Clin. Pharmacol. 4:517-521.
2. ALVAREZ, B., M.J. DAHLITZ, J. VIGNAN, J.D. PARKES (1992) The delayed sleep-phase syndrome: Clinical and investigative findings in 14 subjects. J. Neurol. Neurosurg. Psychiatry 55:665-670.
3. CAJOCHEN, C., K. KRÄUCHI, M.-A. VON ARX, D. MÖRI, P. GRAW, A. WIRZ-JUSTICE (1996) Daytime melatonin administration enhances sleepiness and theta/alpha activity in the waking EEG. Neurosci. Lett. 207:209-213.
4. CAVALLO, A. (1993) Melatonin and human puberty: Current perspectives. J. Pineal Res. 15:115-121.
5. CAVALLO, A., W.A. RITSCHEL (1996) Pharmacokinetics of melatonin in human sexual maturation. J. Clin. Endocrinol. Metab. 81:1882-1886.
6. DAWSON, D., S. GIBBON, P. SINGH (1996) The hypothermie effect of melatonin on core body temperature: Is more better? J. Pineal Res. 20:192-197.
7. DEACON, S., J. ARENDT (1995) Melatonin induces temperature suppression and its acute phase-shifting effects correlate in a dose dependent manner in humans. Brain Res. 688:77-85.
8. DOLBERG, O.T., S. HIRSCHMAN, L. GRUNHAUS (1998) Melatonin for the treatment of sleep disturbances in major depressive disorders. Am. J. Psychiatry 155:1119-1121.
9. ETZIONI, A., R. LUBOSHITZKY, D. TIOSANO, M. BENHARUSH, D. GOLDSHER, P. LAVIE (1996) Melatonin replacement corrects sleep disturbance in a child with pineal tumor. Neurology 46:261-263.
10. FAUTECK, J., H. SCHMIDT, A. LERCHL, G. KURLEMANN, W. WITTKOWSKI (1999) Melatonin in epilepsy: First results of replacement therapy and first clinical results. Biol. Signals Recept. 8:105-110.
11. GARFINKEL, D., M. LAUDON, D. NOF, N. ZISAPEL (1995) Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet 346:541-544.
12. GARFINKEL, D., M. LAUDON, N. ZISAPEL (1997) Improvement of sleep quality by controlled-release melatonin in benzodiazepine-treated elderly insomniacs. Arch. Gerontol. Geriatr. 24:223-231.
13. HAIMOV, I., P. LAVIE, M. LAUDON, P. HERER, C. VIGDER, N. ZISAPEL (1995) Melatonin replacement therapy of elderly insomniacs. Sleep 18:598-603.
14. HOFFMANN, A., K. FARKER, M. DITTGEN, H. HOFFMANN (1999) A melatonin preparation with a pulsatile liberation pattern: A new form of melatonin in replacement therapy. Biol. Signals Recept. 8:96-104.
15. JAN, J.E., M.E. O'DONNELL (1996) Use of melatonin in the treatment of paediatric sleep disorders. J. Pineal Res. 21:193-199.
16. JAN, J.E., M.B.C. CONNOLLY, D. HAMILTON, R.D. FREEMAN, M. LAUDON (1999a) Melatonin treatment of non-epileptic myoclonus in children. Dev. Med. Child Neurol. 41:255-259.
17. JAN, J.E., R.D. FREEMAN, D.K. FAST (1999b) Melatonin treatment of sleep wake cycle disorders in children and adolescents. Dev. Med. Child Neurol. 41:491-500.
18. LAVIE, P., I. HAIMOV, T. SHOCHAT (1997) Melatonin-shutting off the wakefulness system. In: Therapeutic Potential of Melatonin, G.J.M. Maestroni, A. Conti, R.J. Reiter, eds. Karger, New York, pp. 149-160.
19. LIU, C., D.R. WEAVER, X. JIN, L.P. SHEARMAN, R.L. PIESCHL, V.K. GRIBKOFF, S.M. REPPERT (1997) Molecular dissection of two distinct actions of melatonin on the suprachiasmatic circadian clock. Neuron 19:91-102.
20. LOCKLEY, S.W., D.J. SKENE, H.J. TABANDEH, A.C. BIRD, R. DEFRANCE, J. ARENDT (1997) Relationship between napping and melatonin in the blind. J. Biol. Rhythms 12:16-25.
21. MIDDLETON, B., J. ARENDT, B.M. STONE (1997) Complex effects of melatonin on human circadian rhythms in constant dim light. J. Biol. Rhythms 12:467-477.
22. MIYAMOTO, A., J. OKI, S. TAKAHASHI, A. OKUNO (1999) Serum melatonin kinetics and long-term melatonin treatment for sleep disorders in Rett syndrome. Brain Dev. 21:59-62.
23. MUÑOZ-HOYOS, A., M. SÁNCHEZ-FORTE, A. MOLINA-CARBALLO, G. ESCAMES, E. MARTIN-MEDINA., R.J. REITER, J.A. MOLINA-FONT, D. ACUÑA-CASTROVIEJO (1998) Melatonin's role as an anticonvulsant and neuronal protector: Experimental and clinical evidence. J. Child. Neurol. 13:501-509.
24. O'CALLAGHAN, F.J.K., A.A. CLARKE, E. HANCOCK, A. HUNT, J.P. OSBORNE (1999) Use of melatonin to treat sleep disorders in tuberous sclerosis. Dev. Med. Child Neurol. 41:123-126.
25. PALM, L., G. BLENNOW, L. WETTERBERG (1991) Correction of non-24-hour sleep wake cycle by melatonin in a blind, retarded boy. Ann. Neurol. 29:336-339.
26. PALM, L., G. BLENNOW, L. WETTERBERG (1997) Long-term melatonin treatment in blind children and young adults with circadian sleep wake disturbances. Dev. Med. Child Neurol. 39:319-325.
27. PETTERBORG, L.J., B.E. THALEN, B.F. KJELLMAN, L. WETTERBERG (1991) Effect of melatonin replacement on serum hormone rhythms in a patient lacking endogenous melatonin. Brain Res. Bull. 27:181-185.
28. SACK, R.L., R.J. HUGHES, D.M. EDGAR, A.J. LEWY (1997) Sleep promoting effects of melatonin: At what dose, in whom, under what conditions and by what mechanisms. Sleep 20:908-915.
29. TZINSCHINSKY, O., R. SKENE, R. EPSTEIN, Y. DAGAN, P. LAVIE (1991) Circadian rhythms in 6-sulphatoxymelatonin and nocturnal sleep in blind children. Chronobiol. Int. 8:168-175.
30. WALDHAUSER, F., G. WEISZENBACHER, E. TATZER, B. GISINGER, M. WALDHAUSER, M. SCHEMPER, H. FRISCH (1988) Alterations in nocturnal serum melatonin levels in humans with growth and aging. J. Clin. Endocrinol. Metab. 66:648-652.
31. ZHDANOVA, I.V., R.J. WURTMAN, J. WAGSTAFF (1999) Effects of a low dose of melatonin on sleep in children with Angelman syndrome. J. Pediatr. Endocrinol. Metab. 12:57-67.