Prolonged-release melatonin for the treatment of Insomnia in patients over 55 years

Expert Opinion on Investigational Drugs

Volumn 17, Issue 10, 2008, Pages 1567-1572

  Wade, Alan ^a   Downie, Susan ^a  

^a CPS Research   (United Kingdom)

Author keywords

Circadin ; Elderly patients; Insomnia; Melatonin; Morning alertness; Quality of sleep

Indexed keywords

BENZODIAZEPINE; CIMETIDINE; DESIPRAMINE; HYPNOTIC AGENT; IMIPRAMINE; MELATONIN; PLACEBO; THIORIDAZINE;

ASTHENIA; BACKACHE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG MARKETING; DRUG MEGADOSE; DRUG METABOLISM; DRUG POTENTIATION; DRUG RELEASE; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; HANGOVER; HEADACHE; HUMAN; INSOMNIA; LONG TERM CARE; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MEMORY DISORDER; MONOTHERAPY; PHARMACODYNAMICS; PHARYNGITIS; PROLONGED DRUG RELEASE; REBOUND INSOMNIA; REVIEW; STRUCTURE ANALYSIS; WITHDRAWAL SYNDROME;

AGED; CLINICAL TRIALS, PHASE III AS TOPIC; DELAYED-ACTION PREPARATIONS; HUMANS; MELATONIN; MIDDLE AGED; SLEEP INITIATION AND MAINTENANCE DISORDERS;

EID: 52949090833     PISSN: 13543784     EISSN: None     Source Type: Journal    
DOI: 10.1517/13543784.17.10.1567     Document Type: Review

References (46)

1. Dement WC, Miles LE, Carskadon MA. "White paper" on sleep and aging. J Am Geriatr Soc 1982;30(1):25-50
2. Monane M. Insomnia in the elderly. J Clin Psychiatry 1992;53(Suppl):23-8
3. Morphy H, Dunn KM, Lewis M, et al. Epidemiology of insomnia: a longitudinal study in a UK population. Sleep 2007;30(3):274-80
4. American Psychiatric Association TFoD-I: Task Force on DSM-TV In: Diagnostic and statistical manual of mental disorders. 4th edition. Text revision (DSM-IV-TR). Washington DC: American Psychiatric Association; 2000
5. Roth T, Roehrs T. Insomnia: epidemiology, characteristics, and consequences. Clin Cornerstone 2003;5(3):5-15
6. DSM-IV APA. Diagnostic and statistical manual of mental disorders - DSM-IV. 4th edition. Washington DC; 1994
7. ICD-10 WHO. Tenth revision of the international classification of diseases. Chapter V (F). Mental and behavioural disorders. Clinical descriptions and diagnostic guidelines. Geneva 182/184: WHO; 1992
8. Roth T, Ancoli-Israel S. Daytime consequences and correlates of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. II. Sleep 1999;22(Suppl 2):S354-8
9. Leger D, Guilleminault C, Deframce R, et al. Prevalence of sleep/wake disorders in persons with blindness. Clin Sci 1999;97:193-9
10. Brassington GS, King AC, Bliwise DL. Sleep problems as a risk factor for falls in a sample of community-dwelling adults aged 64-99 years. J Am Geriatr Soc 2000;48(10):1234-40
11. Medaine A, Leger D, Choudat D. Socioeconomic impact of insomnia in working populations. Ind Health 2005;43(1):11-9
12. Avidan AY, Fries BE, James ML, et al. Insomnia and hypnotic use, recorded in the minimum data set, as predictors of falls and hip fractures in Michigan nursing homes. J Am Geriatr Soc 2005;53(6):955-62
13. Ozminkowski RJ, Wang S, Walsh JK. The direct and indirect costs of untreated insomnia in adults in the United States. Sleep 2007;30(3):263-73
14. Hajak G. Epidemiology of severe insomnia and its consequences in Germany. Eur Arch Psychiatry Clin Neurosci 2001;251(2):49-56
15. Riemann DFJ, Mayer G, Peter JH. The Guidelines for Non-Restorative Sleep: relevance for the diagnosis and therapy of insomnia. Somnologie 2003;7(2):66-76
16. Szabadi E. Drugs for sleep disorders: mechanisms and therapeutic prospects. Br J Clin Pharmacol 2006;61(6):761-6
17. Glass J, Lanctot KL, Herrmann N, et al. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ 2005;19(331):1169-76
18. Krystal AD. Treating the health, quality of life, and functionall impairments insomnia. J Clin Sleep Med 2007;3(1):63-72
19. Reiter RJ. Melatonin: the chemical expression of darkness. Mol Cell Endocrinol 1991;79(1-3):C153-8
20. Witt-Enderby PA, Bennett J, Jarzynka MJ, et al. Melatonin receptors and their regulation; biochemical and structural mechanisms. Life Sci 2003;72(20):2183-98
21. Zisapel N, Tarrasch R, Laudon M. The relationship between melatonin and cortisol rhythms: clinical implications of melatonin, therapy. Drug Dev Res 2005;65(3):119-25
22. Zisapel N. Sleep and sleep disturbances: biological basis and clinical implications. Cell Mol Life Sci 2007;64(10):1174-86
23. Nair NPV, Hariharasubramanian N, Pilapil C, et al. Plasma melatonin - an index of brain aging in humans? Biol Psychiatry 1986;21:141-50
24. Waldhauser F, Waldhauser M, Lieberman HR, et al. Bioavailability of oral melatonin in humans. Neuroendocrinology 1984;39(4):307-13
25. Arendt J, Skene DJ. Melatonin as a chronobiotic. Sleep Med Rev 2005;9(1):25-39
26. Arendt J. Melatonin and the mammalian pineal gland. London: Chapman & Hall; 1995
27. EMEA: Circadin EPA Report. 2007. Available from: http://www.emea.europa.eu/humandocs/PDFs/EPAR/circadin/H-695-en6.pdf
28. Haimov I, Lavie P, Laudon M, et al. Melatonin replacement therapy of elderly insomniacs. Sleep 1995;18(7):598-603
29. Garfinkel D, Laudon M, Nof D, Zisapel N. Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet 1995;346(8974):541-4
30. Wurtman RJ, Zhdanova I. Improvement of sleep quality by melatonin. Lancet 1995;346(8988):1491
31. Hughes RJ, Sack R, Lewy A. The role of melatonin and circadian Phase In age-related sleep-maintenance insomnia: assessment in a clinical trial of melatonin replacement. Sleep 1998;21(1):52-68
32. Leger D, Laudon M, Zisapel N. Nocturnal 6-sulfatoxymelatonin excretion in insomnia and its relation to the response to melatonin replacement therapy. Am J Med 2004;116(2):91-5
33. Karasek M. Melatonin, human aging, and age-related diseases. Exp Gerontol 2004;39(11-12):1723-9
34. Jean-Louis G, Kripke DF, Ancoli-Israel S. Sleep and quality of well-being. Sleep 2000;23(8):1115-21
35. 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(12):1151-8
36. Brzezinski A, Vangel MG, Wurtman RJ, et al. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev 2005;9(1):41-50
37. Lemoine P, Nir T, Laudon M, Zisapel N. Prolonged-release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects. J Sleep Res 2007;16:372-80
38. Wade A, Ford I, Crawford G, et al. Efficacy of prolonged release melatonin in insomnia patients aged 55-80 years: quality of sleep and next-day alertness outcomes. Curr Med Res Opin 2007;23:2597-605
39. Tarrasch R, Laudon M, Zisapel N. Cross-cultural validation of the Leeds sleep evaluation questionnaire (LSEQ) in insomnia patients. Hum Psychopharmacol 2003;18(8):603-10
40. Buysse DJ, Ancli-Israel S, Edinger JD, et al. Recommendations for a standard research assessment of insomnia. Sleep 2006;29(9):1155-76
41. Otmani S, Demazieres A, Staner C, et al. Effects of prolonged-release melatonin, zolpidem and their combination on psychomotor functions memory recall and driving skills in healthy middle aged and elderly volunteers. Hum Psychopharmacol 2008 [Epub ahead of print)
42. Garfinkel D, Laudon M, Zisapel N. Improvement of sleep quality by controlled-release melatonin in benzodiazepine-treated elderly insomniacs. Arch Gerontol Geriatr 1997;24(2):223-31
43. 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(7538):385-93
44. Buysse DJ, Reynolds CF III, Monk TH, et al. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 1989;28(2):193-213
45. Tekbas OF, Ogur R, Korkmaz A, et al. Melatonin as an antibiotic: new insights into the actions of this ubiquitous molecule; J Pineal Res 2008;44(2):222-6
46. Ayer RE, Sugawara T, Chen W, et al. Melatonin decreases mortality following severe subarachnoid hemorrhage. J Pineal Res 2008;44(2):197-204