Searching for new options for treating insomnia: Are melatonin and ramelteon beneficial?

Journal of Psychiatric Practice

Volumn 12, Issue 4, 2006, Pages 229-243

  Bellon, Alfredo ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

Circadian rhythms; Delayed sleep phase syndrome; Insomnia; Melatonin; Ramelteon; Sleep

Indexed keywords

BENZODIAZEPINE DERIVATIVE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; HORMONE RECEPTOR STIMULATING AGENT; MELATONIN; MELATONIN RECEPTOR; METHYLPHENIDATE; NONSTEROID ANTIINFLAMMATORY AGENT; PHENOBARBITAL; PLACEBO; RAMELTEON; UNCLASSIFIED DRUG; ZOPICLONE;

ATTENTION DEFICIT DISORDER; CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; DELAYED SLEEP PHASE SYNDROME; DEMENTIA; DISEASE ASSOCIATION; DIZZINESS; DRUG INDUCED HEADACHE; DRUG TREATMENT FAILURE; FATIGUE; HUMAN; INSOMNIA; NAUSEA; RETT SYNDROME; REVIEW; SCHIZOPHRENIA; SLEEP TIME; SOMNOLENCE; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

ADMINISTRATION, INTRANASAL; ADULT; AGED; CIRCADIAN RHYTHM; FEMALE; HUMANS; INDENES; INJECTIONS, INTRAVENOUS; MALE; MELATONIN; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS;

EID: 33746858161     PISSN: 15274160     EISSN: None     Source Type: Journal    
DOI: 10.1097/00131746-200607000-00005     Document Type: Review

References (106)

1. Buysse DJ, Germain A, Moul DE. Diagnosis, epidemiology and consequences of insomnia. Primary Psychiatry 2005;12:37-44.
2. Wang MY, Wang SY, Tsai PS. Cognitive behavioural therapy for primary insomnia: A systematic review. J Adv Nurs 2005;50:553-64.
3. National Institutes of Health Consensus Conference. Drugs and insomnia: The use of medications to promote sleep. JAMA 1984;251:2410-14.
4. Greenblatt DJ, Shader RI, Abernethy DR. Drug therapy: Current status of benzodiazepines. N Engl J Med 1983;309:354-58.
5. Mendelson WB. A review of the evidence for the efficacy and safety of trazodone in insomnia. J Clin Psychiatry 2005;66:469-76.
6. Krystal AD. The changing perspective on chronic insomnia management. J Clin Psychiatry 2004;65(suppl 8):20-25.
7. Erman M, Seiden D, Zammit G, et al. An efficacy, safety and dose-response study of ramelteon in patients with chronic primary insomnia. Sleep Med 2006;7:17-24.
8. Lerner AB, Case JD, Heinzelman RV. Structure of melatonin. J Am Chem Soc 1959;81:6084.
9. Lerner AB, Case JC. Melatonin. Fed Proc 1960;19:590-2.
10. Vanecek J. Cellular mechanism of melatonin action. Physiol Rev 1998;78:687-721.
11. Anton-Tay F, Diaz JL, Fernandez-Guardiola A. On the effect of melatonin upon the human brain: Its possible therapeutic implications. Life Sci 1971;10:841-50.
12. Barchas J, DaCosta F, Spector S. Acute pharmacology of melatonin. Nature 1967;214:919-20.
13. Cramer H, Rudolph J, Consbruch U, et al. On the effects of melatonin on sleep and behaviour in man. Adv Biochem Psychopharmacol 1974;11:187-91.
14. Vollrath L, Semm P, Gammel G. Sleep induction by intranasal application of melatonin. Adv Biosci 1981;29:327-29.
15. Lieberman H. Behaviour, sleep and melatonin. 1986;21:233-41.
16. Attenburrow MEJ, Cowen PJ, Sharpley AL. Low doses of melatonin improves sleep in healthy meddle-aged subjects. Psychopharmacology 1996;126:179-81.
17. James SP, Mendelson WB, Sack DA, et al. The effect of melatonin on normal sleep. Neursopsychopharmacology 1987;1:41-4.
18. Sack RL, Hughes RJ, Edgar DM, et al. Sleep-promoting effects of melatonin: At what dose, in whom, under what conditions, and by what mechanisms? Sleep 1997;20:908-15.
19. Buscemi N, Vandermeer B, Pandya R, et al. Melatonin for the treatment of sleep disorders. Evid Rep Technol Assess 2004;108:1-151.
20. Buscemi N, Vandermeer B, Hooton N, et al. The efficacy and safety of exogenous melatonin for primary sleep disorders: A meta-analysis. J Gen Intern Med 2005;20:1151-8.
21. Buscemi N, Vandermeer B, Hooton N, et al. Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: Meta-analysis. BMJ 2006;332:385-93.
22. Akerstedt T, Froberg JE, Friberg Y, et al. Melatonin excretion, body temperature and subjective arousal during 64 hours of sleep deprivation. Psychoendocrinology 1979;4:219-25.
23. Tzischinsky O, Shlitner A, Lavie P. The association between the nocturnal sleep gate and nocturnal onset of urinary 6-sulfatoxymelatonin. J Biol Rhythms 1993;8:199-209.
24. Dubocovich ML, Rivera-Bermudez MA, Gerdin MJ, et al. Molecular pharmacology, regulation and function of mammalian melatonin receptors. Front Biosci 2003;1:1093-108.
25. von Gall C, Stehle JH, Weaver DR. Mammalian melatonin receptors: Molecular biology and signal transduction. Cell Tissue Res 2002;309:151-62.
26. Kato K, Hirai K, Nishiyama K, et al. Neurochemical properties of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology 2005;48:301-10.
27. Karim A, Tolbert D, Cao C. Disposition kinetics and tolerance of escalating single doses of ramelteon, a high-affinity MT1 and MT2 melatonin receptor agonist indicated for the treatment of insomnia. J Clin Pharmacol 2006;46:140-8.
28. Dubocovich ML. Melatonin receptors: Are there multiple subtypes? Trend Pharmacol Sci 1995;16:50-6.
29. Paul P, Lahaye C, Delagrange P, et al. Characterization of 2-[125I]iodomelatonin binding sites in Syrian hamsters peripheral organs. J Pharmacol Exp Ther 1999;290:334-40.
30. Nosjean O, Ferro M, Coge F, et al. Identification of the melatonin binding site MT3 as the quinone reductasa 2. J Biol Chem 2000;275:31311-7.
31. Nosjean O, Nicolas JP, Klupsch F, et al. Comparative pharmacological studies of melatonin receptors: MT1, MT2 and MT3/QR2. Tissue distribution of MT3/QR2. Biochem Pharmacol 2001;61:1369-79.
32. Barrett P, Conway S, Morgan PJ. Digging deep-structure-function relationships in the melatonin receptor family. J Pineal Res 2003;35:221-30.
33. MacFarlane JG, Cleghorn JM, Brown mg, et al. The effects of exogenous melatonin on the total sleep time and daytime alertness of chronic insomniacs: A preliminary study. Biol Psychiatry 1991;30:371-6.
34. James SP, Sack DA, Rosenthal NE. Melatonin administration and insomnia. Neuropsychopharmacology 1990;3:19-23.
35. Ellis CM, Lemmens G, Parkes JD. Melatonin and insomnia. J Sleep Res 1996;5:61-5.
36. Almeida Montes LG, Ontiveros Uribe MP, Cortes Sotres J, et al. Treatment of primary insomnia with melatonin: A double-blind, placebo-controlled, crossover study. J Psychiatry Neurosci 2003;28:191-6.
37. Dahlitz M, Alvarez B, Vignau J, et al. Delayed sleep phase syndrome response to melatonin. Lancet 1991;337:1121-4.
38. Nagtegaal JE, Kerkhof GA, Smits MG, et al. Delayed sleep phase syndrome: A placebo-controlled crossover study on the effects of melatonin administered five hours before the individual dim light melatonin onset. J Sleep Res 1998;7:135-43.
39. Kayumov L, Brown G, Jindal R, et al. A randomized, double-blind, placebo-controlled crossover study of the effect of exogenous melatonin on delayed sleep phase syndrome. Psychosom Med 2001;63:40-8.
40. Beck AT, Ward CH, Mendelson M, et al. An inventory for measuring depression. Arch Gen Psychiatry 1961;4:561-71.
41. Tzishinsky O, Lavie P. Melatonin possesses time-dependent hypnotic effects. Sleep 1994;17:638-45.
42. Hughes RJ, Badia P. Sleep-promoting and hypothermic effects of daytime melatonin administration. Sleep 1997;20:124-31.
43. Dawson D, Gibbon S, Singh P. The hypothermic effect of melatonin on core body temperature: Is more better? J Pineal Res 1996; 20 192-7.
44. Regestein QR, Monk TH. Delayed sleep phase syndrome: A review of its clinical aspects. Am J Psychiatry 1995;152:602-28.
45. Aldrich MS. Sleep disorders. Neurologic Clinics 1996;14:651-7.
46. Weitzman ED, Czeisler CA, Coleman RM, et al. Delayed sleep phase syndrome, a chronobiological disorder with sleep-onset insomnia. Arch Gen Psychiatr 1981;38:737-46.
47. Hoddes E, Dement W, Zarcone V. The development and use of the Stanford Sleepiness Scale (SSS). Psychophysiology 1971;9:150.
48. Smits MG, Nagtegaal EE, van der Heijden J, et al. Melatonin for chronic sleep insomnia in children: A randomized placebo-controlled trial. J Child Neurol 2001;16:86-92.
49. Smits MG, van Stel HF, van der Heijden K, et al. Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: A randomized placebo-controlled trial. J Am Acad Child Adolesc Psychiatry 2003;42:1286-93.
50. O'Callaghan FJK, Clarke AA, Hancock E, et al. Use of melatonin to treat sleep disorders in tuberous sclerosis. Dev Med Child Neurol 1999;41:123-6.
51. McArthur AJ, Budden SS. Sleep dysfunction in Rett syndrome: A trial of exogenous melatonin treatment. Dev Med Child Neurol 1998;40:186-92.
52. Stein RE, Jessop DJ. Functional status II(R). A measure of child health status. Med Care 1990;28:1041-55.
53. Lewis CC, Pantell RH, Kieckhefer MG. Assessment of children's health status. Field test of new approaches. Med Care 1989;27:S54-S65.
54. Hunt A. Development, behaviour and seizures in 300 cases of tuberous sclerosis. J Intellect Disabil Res 1993;37:41-51.
55. Hunt A, Stores G. Sleep disorders and epilepsy in children with tuberous sclerosis: A questionnaire-based study. Dev Med Child Neurol 1994;36:108-15.
56. Rogers AE, Caruso DD, Aldrich MS. Reliability of sleep diaries for assessment of sleep/wake patterns. Nurs Res 1993;42:368-72.
57. Clements J,Wing L, Dunn G. Sleep problems in handicapped children: A preliminary study. J Child Psychol Psychiatry 1986;27:339-407.
58. Sekul E, Percy A. Rett syndrome: Clinical features, genetic considerations and the search for a biological marker. Curr Neurol 1992;12;173-200.
59. Hagberg B, Witt-Engerstrom I. Rett syndrome: A suggested staging system for describing impairment profile with increasing age towards adolescence. Am J Med Genet Suppl 1986;1:47-59.
60. Trevathan E, Naidu S. The clinical recognition and differential diagnosis of Rett syndrome. J Child Neurol 1988;3:S6-S16.
61. Sadeh A, Alster J, Urbach D, et al. Actigraphically based automatic bedtime sleep-wake scoring: validity and clinical applications. J Ambu Monit 1989;2:209-16.
62. Sadeh A, Lavie P, Scher A, et al. Actigraphic home-monitoring sleep-disturbed and control infants and young children: A new method for pediatric assessment of sleep-wake patterns. Pediatrics 1991;87:494-9.
63. Garfinkel D, Laudon M, Nof D, et al. Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet 1995;346:541-4.
64. Iguchi H, Kato K, Ibayashi H, et al. Age-dependent reduction in serum melatonin concentrations in healthy human subjects. J Clin Endocr Metab 1982;55:27-9.
65. Sack RL, Lewy AJ, Erb DL, et al. Human melatonin production decreases with age. J Pineal Res 1986;3:379-88.
66. Sharma M, Placios-Bois J, Schwartz G, et al. Circadian rhythms of melatonin and cortisol in aging. Biol Psychiatry 1989;25:305-19.
67. Touitou Y, Fevre M, Bogdan A, et al. Patterns of plasma melatonin with aging and mental conditions: Stability of nyctohemeral rhythms and differences in seasonal variations. Acta Endocrinol (Copenh) 1984;106:145-51.
68. Waldhauser F, Ehrhart B, Forster E. Clinical aspects of the melatonin action: Impact of development, aging and puberty, involvement of melatonin in psychiatric disease and importance of neuroimmunoendocrine interactions. Experientia 1993;49:671-81.
69. Bliwise DL. Sleep in normal aging and dementia. Sleep 1993;16:40-81.
70. Haimov I, Peretz L, Laudon M, et al. Melatonin replacement therapy of elderly insomniacs. Sleep 1995;18:598-603.
71. Hughes RJ, Sack RL, Lewy AJ. The role of melatonin and circadian phase in age-related sleep-maintenance insomnia: Assessment in a clinical trial of melatonin replacement. Sleep 1998;21:52-68.
72. Zhdanova IV,Wurtman RJ, Regan MM, et al. Melatonin treatment for age-related insomnia. J Clin Endocrinol Metab 2001;86:4727-30.
73. Baskett JJ, Broad JB,Wood PC, et al. Does melatonin improve sleep in older people? A randomized crossover trial. Age and Ageing 2003;32:164-70.
74. Arendt J, Bojkowski C, Franey C, et al. Immunoassay of 6-hydroxymelatonin sulphate in human plasma and urine: Abolition of the urinary 24-hour rhythm with atenolol. J Clin Endocrinol Metab 1985;60:1166-73.
75. McIntyre IM, Norman TR, Burrows GD, et al. Alterations to plasma melatonin and cortisol after evening alprazolam administration in humans. Chronobiol Int 1993;10:205-13.
76. de Jongh EA, Nordstrom SL, Hughes RJ, et al. Techniques for successful unattended polysomnographic studies. Sleep Res 1997;26:642.
77. Dollins AB, Zhdanova IV Wurtman RJ, et al. Effect of inducing nocturnal serum melatonin concentrations in daytime on sleep, mood, body temperature and performance. Proc Natl Accad Sci 1994;91:1824-8.
78. Murphy PJ, Badia P, Bryan L, et al. Nonsteroidal anti-inflammatory drugs affect normal sleep patterns in humans. Physiol Behav 1994;55:1063-6.
79. Murphy PJ, Myers BL, Badia P. Nonsteroidal anti-inflammatory drugs alter body temperature and suppress melatonin in humans. Physiol Behav 1996;59:133-9.
80. Murphy PJ, Myers BL, Wright K, et al. Nonsteroidal antiinflammatory drugs and melatonin levels in humans. Sleep Res 1993;22:372.
81. Surrall K, Smith JA, Bird H, et al. Effect of ibuprofen and indomethacin on human plasma melatonin. J Pharm Pharmacol 1987;39:840-3.
82. Cahalan D, Cisin IH. American drinking practices: Summary of findings from a national probability sample: I. Extent of drinking by population subgroup. Quarterly Journal of Studies on Alcohol 1968;29:130-51.
83. Hindmarch I, Parrot AC, Arenillas L. A repeated dose comparison of dichloralphenazone, flunitrazepam and amylobarbitone sodium on some aspects of sleep and early morning behavior in normal subjects. Br J Clin Pharmocol 1977;4:229-33.
84. Roehrs T, Roth T. Sleep, sleepiness and alcohol use. Alcohol Res Health 2001;101-9.
85. Leonard TK,Watson RR, Mohs ME. The effects of caffeine on various body systems: A review. J Am Diet Assoc 1987;87:1048-53.
86. Shamir E, Laudon M, Barak Y, et al. Melatonin improves sleep quality of patients with chronic schizophrenia. J Clin Psychiatry 2000;61:373-7.
87. Andrade C, Srihari BS, Reddy KP, et al. Melatonin in medically ill patients with insomnia: A double-blind, placebo-controlled study. J Clin Psychiatry 2001;62:41-5.
88. Serfaty M, Kennell-Webb S,Warner J, et al. Double blind randomized placebo controlled trial of low dose melatonin for sleep disorders in dementia. Int J Geriatr Psychiatry 2002;17:1120-7.
89. Singer C, Tractenberg RE, Kaye J, et al. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep 2003;26:893-901.
90. Ferrier I, Arendt J, Johnston E, et al. Reduced nocturnal melatonin secretion in chronic schizophrenia: Relationship to body weight. Clin Endocrinol 1982;17:181-7.
91. Rao M, Gross G, Strebel B, et al. Serum amino acids, central monoamines and hormones in drug-naive, drug-free and neuroleptics-treated schizophrenic patients and healthy subjects. Psychiatry Res 1990;34:243-57.
92. Robinson S, Rosca P, Durst R, et al. Serum melatonin levels in schizophrenic and schizoaffective hospitalized patients. Acta Psychiatr Scand 1991;84:221-4.
93. Sandyk R, Stanley RK. Pineal melatonin in schizophrenia: A review and hypothesis. Schizophr Bull 1990;16:653-62.
94. Zarcone V, Benson K. BPRS symptom factors and sleep variables in schizophrenia. Psychiatry Res 1997;66:111-20.
95. Swearer J, Drachman D, O'Donell B, et al. Troublesome and disruptive behaviors in dementia. J Am Geriatr Soc 1988;36:784-90.
96. Malpaux B, Migaud M, Tricoire H, et al. Biology of mammalian photoperiodism and the critical role of the pineal gland and melatonin. J Biol Rhythms 2001;16:336-47.
97. Mishima K, Tozawa T, Satoh K, et al. Melatonin secretion rhythm disorders in patients with senile dementia of Alzheimer's type with disturbed sleep-waking. Biol Psychiatry 1999;45:417-21.
98. Singer C, McArthur A, Hughes R, et al. Physiologic melatonin administration and sleep in the elderly. Sleep Res 1995;24A:152.
99. Singer C, McArthur A, Hughes R, et al. High dose of melatonin and sleep in the elderly. Sleep Res 1995;24A.151.
100. Parrot AC, Hindmarsh I. Factor analysis of sleep evaluation questionnaire. Psychol Med 1978;8:325-9.
101. Sadock BJ, Sadock VA. Comprehensive textbook of psychiatry. Lippincott Williams & Wilkins 2005;868:1073-4.
102. Roth R, Stubbs C, Walsh JK. Ramelteon (TAK-375), a selective MT1/MT2-receptor agonist, reduces latency to persistent sleep in a model of transient insomnia related to a novel sleep environment. Sleep 2005;28:303-7.
103. Roth T, Seiden D, Sainati S, et al. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med 2006;7:312-8.
104. Elie R, Ruther E, Farr I, et al. Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. J Clin Psychiatry 1999;60:536-44.
105. Roth T, Roehrs T, Vogel G. Zolpidem in the treatment of transient insomnia: A double-blind, randomized comparison with placebo. Sleep 1995;18:246-51.
106. Praast G, Bartsch C, Bartsch H, et al. Hepatic hyperoxylation of melatonin in the rat is induced by phenobarbital and 7,12 dimethylbenzanthracene-implications for cancer etiology. Experientia 1995:51:349-55.