Ramelteon: A novel treatment for the treatment of insomnia

Expert Review of Neurotherapeutics

Volumn 6, Issue 7, 2006, Pages 957-964

  Wurtman, Richard ^a  

^a MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

Author keywords

aminobutyric acid receptors; Aging; Downregulation; Melatonin; MT1 receptors; MT2 receptors; Pineal; Ramelteon; Sleep

Indexed keywords

MELATONIN; RAMELTEON; UNCLASSIFIED DRUG;

CIRCADIAN RHYTHM; DOSE RESPONSE; HUMAN; INSOMNIA; JET LAG; NEUROTRANSMISSION; PEER REVIEW; REVIEW; SLEEP; UNSPECIFIED SIDE EFFECT;

CLINICAL TRIALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HUMANS; INDENES; MELATONIN; PHYSICIAN'S PRACTICE PATTERNS; RECEPTORS, MELATONIN; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME;

EID: 33745938427     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/14737175.6.7.957     Document Type: Review

References (47)

1. Lynch HJ, Wurtman RJ, Moskowitz MA et al. Daily rhythm in human urinary melatonin. Science 184, 169-171 (1975).
2. Brzezinski A. Melatonin in humans. N. Engl. J. Med. 336, 186-195 (1997).
3. Wurtman, R.J. Melatonin. In: Encyclopedia of Dietary Supplements. Coates P (Ed.), Marcel Dekker, 457-466 (2005).
4. Dollins AB, Zhdanova IV, Wurtman RJ et al. Effect of inducing nocturnal serum melatonin concentration in daytime on sleep, mood, body temperature and performance. Proc. Natl. Acad. Sci. USA 91, 1824-1828 (1994).
5. Zhdanova IV, Wurtman RJ. Efficacy of melatonin as a sleep-promoting agent. J. Biol. Rhythms 112, 644-650 (1997).
6. Zhdanova IV, Wurtman RJ, Regan MM, Taylor JA, Shi JP, LeClair OU. Melatonin treatment for age-related insomnia. J. Clin. Endocrin. Metab. 86(10), 4727-4730 (2001).
7. Brzezinski A, Vangel MG, Wurtman RJ et al. Effect of exogenous melatonin on sleep - a meta-analysis of 14 controlled clinical trials. Sleep Med. Rev. 9, 41-50 (2005).
8. Stone BM, Turner C, Mills SL, Nicholson AN. Hypnotic activity of melatonin. Sleep 23, 663-669 (2000).
9. Zhdanova IV, Wurtman RJ, Lynch HJ et al. Sleep-inducing effects of low-doses of melatonin ingested in the evening. Clin. Pharmacol. Ther. 57, 657-665 (1997).
10. Haimov I, Laudon M, Zisapel N et al. Sleep disorders and melatonin rhythms in elderly people. BMJ 309, 167 (1994).
11. Touitou Y. Some aspects of the circadian time structure in the elderly. Gerontology 28(Suppl. 1), 53-67 (1982).
12. Iguchi H, Kato KI, Ibayashi H. Age-dependent reduction in serum melatonin concentrations in healthy human subjects. J. Clin. Endocrinol. Metab. 55, 27-29 (1982).
13. Zhdonova IV, Wurtman RJ, Balcioglu A, Kartashov A, Lynch HJ. Endogenous melatonin levels and the fate of exogenous melatonin: age effects. J. Gerontol. 53A, B293-B298 (1998).
14. Sack RL, Lewy AJ, Erb DL, Vollmer WM, Singer CM. Human melatonin production decreases with age. J. Pineal Res. 3, 379-388 (1986).
15. Gerdin MJ, Masana MI, Dubocovich ML. Melatonin-mediated regulation of human MT1 melatonin receptors expressed in mammalian cells. Biochemical Pharmacology 67, 2023-2030 (2004).
16. Gerdin MJ, Masana MI, Rivera-Bermudez MA et al. Melatonin desensitizes endogenous MT2 receptors in the rat suprachiasmatic nucleus: relevance for defining the periods of sensitivity of the mammalian circadian clock to melatonin. FASEB J. 18(14), 1646-1656 (2004).
17. Kato K, Hirai K, Nishiyama K et al. Neurochemical properties of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology 48, 301-310 (2005).
18. Stevenson S, Bryson S, Amakye D et al. Study to investigate the absolute bioavailability of a single oral dose of ramelteon (TAK-375) in healthy male subjects. Clin. Pharmacol. Ther. 75, 22 (2004).
19. McGechan A, Wellington K. Ramelteon. CNS Drugs 19, 1057-1065 (2005).
20. Cajochen TC. TAK-375. Curr. Opin. Inves. Drugs 6, 114-121 (2005).
21. ROZEREM™ (ramelteon) Tablets. Package Insert (2005).
22. No authors listed. Ramelteon (Rozerem) for insomnia. The Medical Letter On Drugs and Therapeutics 47(1221), 89-91 (2005).
23. Roth T, Stubbs C, Walsk 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 28, 303-307 (2005).
24. Erman M, Seiden D, Zammit G, Sainati S, Zhang J. An efficacy, safety, and dose-response study of ramelteon in patients with chronic primary insomnia. Sleep Med. 7, 17-24 (2006).
25. Zammit G, Roth T, Erman M, Sainati S, Weigand S, Zhang J. Double-blind, placebo-controlled polysomnography and outpatient trial to evaluate the efficacy and safety of ramelteon in adult patients with chronic insomnia. Sleep 28(Suppl.) 0680 (2005).
26. Roth T, Seiden D, Zee P et al. Phase III outpatient trial of ramelteon for the treatment of chronic insomnia in elderly patients (abstract A21). J. Am. Geriatr. Soc. 53, S25 (2005).
27. Zammit G, Schwartz H, Roth T, Wright L, Sainati S, Zhang J. Phase III study of ramelteon in a first-night-effect model of transient insomnia. Sleep Med. 550, O007 (2005).
28. Witt-Enderby P, Bennett J, Jarzynka M, Firestine S, Melan M. Melatonin receptors and their regulation: biochemical and structural mechanisms. Life Sciences 72, 2183-2198 (2003).
29. Gauer F, Masson-Pevet M, Skene D, Vivien-Roels B, Pevet P. Daily rhythms of melatonin binding sites in the rat pars tuberalis and suprachiasmatic nucleus; evidence for a regulation of melatonin receptors by melatonin itself. Neuroendocrinology 57, 120-126 (1993).
30. Hazlerigg D, Gonzalez-Brito A, Lawson W, Hastings M, Morgan P. Prolonged exposure to melatonin leads to time-dependent sensitization of adenylate cyclase and downregulates melatonin receptors in pars tuberalis cells from ovine pituitary. Endocrinology 132, 285-292 (1993).
31. Jones M, Melan M, Witt-Enderby P. Melatonin decreases cell proliferation and transformation in a melatonin receptor-dependent manner. Cancer Letters 151, 133-143 (2000).
32. Witt-Enderby P, MacKenzie R, McKeon R, Carroll E, Bordt S, Melan M. Melatonin induction of filamentous structures in non-neuronal cells that is dependent on the expression of the human mt1 melatonin receptor. Cell Motil. Cytoskeleton 46, 28-42 (2000).
33. Nosjean O, Ferro M, Coge F et al. Identification of the melatonin-binding site MT3 as the quinine reductase 2. J. Biol. Chem. 275, 31311-31317 (2000).
34. Griffiths R, Suess P, Johnson M. Ramelteon and triazolam in humans: behavioral effects and abuse potential. Sleep 28(Suppl.) 0132 (2005).
35. Arendt J. Importance and relevance of melatonin to human biological rhythms. J. Neuroendocrinol. 15, 427-431 (2003).
36. Herxheimer A, Petrie KJ. Melatonin for preventing and treating jet lag. Cochrane Database Syst. Rev. (1), CD001520 (2001).
37. Zhdanova IV, Wurtman RJ, Morabito C et al. Effects of low oral doses of melatonin, given 2-4 h before habitual bedtime, on sleep in normal young humans. Sleep 19, 423-431 (1996).
38. Deacon S, Arendt J. Melatonin-induced temperature suppression and its acute phase-shifting effects correlate in a dose-dependent manner in humans. Brain Res. 688, 77-85 (1995).
39. Arendt J, Aldhous M, Wright J. Synchronization of a disturbed sleep-wake cycle in a blind man by melatonin treatment. Lancet 772-773 (1988).
40. Lewy AJ, Emens JS, Lefler BJ et al. Melatonin entrains free-running blind people according to a physiological dose-response curve. Chronobiol. Int. 22, 1093-1206 (2005).
41. Arendt J. Jet-lag and shift work: (2) therapeutic use of melatonin. J. Royal Soc. Med. 92, 402-406 (1999).
42. Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag (Cochrane Review). In: The Cochrane Library Issue 4, John Wiley & Sons, UK (2003).
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 332, 385-393 (2006).
44. Reiter RJ. Oxidative damage in the central nervous system: protection by melatonin. Prog. Neurobiol. 56, 359-384 (1998).
45. Rodriguez C, Mayo JC, Sainz RM et al. Regulation of antioxidant enzymes: a significant role for melatonin. J. Pineal Res. 36, 1-9 (2004).
46. Duell PB, Wheaton DL, Shultz A, Nguyen H. Inhibition of LDL oxidation by melatonin requires supraphysiologic concentrations. Clin. Chem. 44, 9 (1998).
47. Cagnacci A, Cannoletta M, Renzi A et al. Prolonged melatonin administration decreases nocturnal blood pressure in women. Am. J. Hypertens. 18, 1614-1618 (2005).