Safety profile of tasimelteon, a melatonin MT₁ and MT₂ receptor agonist: pooled safety analyses from six clinical studies

Bibliography

• Lavedan C, Forsberg M, Gentile AJ. Tasimelteon: A selective and unique receptor binding profile. Neuropharmacology 2015;91:142-7
   PubMed Web of Science ®Google Scholar
• Torres R, Dressman MA, Kramer WG, Baroldi P. Absolute Bioavailability of Tasimelteon. Am J Ther 2015;22(5):355-60
   PubMed Web of Science ®Google Scholar
• Ogilvie BW, Torres R, Dressman MA, et al. Clinical assessment of drug-drug interactions of tasimelteon, a novel dual melatonin receptor agonist. J Clin Pharmacol 2015;55(9):1004-11
   PubMed Web of Science ®Google Scholar
• Lockley SW, Dressman MA, Licamele L, et al. Two multicentre randomised trials of tasimelteon for the treatment of Non-24-Hour Sleep-Wake Disorder in the blind. Lancet 2014
   Google Scholar
• Rajaratnam SM, Polymeropoulos MH, Fisher DM, et al. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet 2009;373(9662):482-91
   PubMed Web of Science ®Google Scholar
• Hastings MH, Brancaccio M, Maywood ES. Circadian pacemaking in cells and circuits of the suprachiasmatic nucleus. J Neuroendocrinol 2014;26(1):2-10
   PubMed Web of Science ®Google Scholar
• Saper CB. The central circadian timing system. Curr Opin Neurobiol 2013;23(5):747-51
   PubMed Web of Science ®Google Scholar
• Lockley SW, Arendt J, Skene DJ. Visual impairment and circadian rhythm disorders. Dialogues Clin Neurosci 2007;9(3):301-14
   PubMedGoogle Scholar
• American Academy of Sleep Medicine. International classification of sleep disorders-third edition (ICSD-3). 3rd edition. American Academy of Sleep Medicine; 2014
   Google Scholar
• American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 5th edition (DSM-5). 5 edition. 2013
   Google Scholar
• Leger D, Partinen M, Hirshkowitz M, et al. Characteristics of insomnia in a primary care setting: EQUINOX survey of 5293 insomniacs from 10 countries. Sleep Med 2010;11(10):987-98
   PubMed Web of Science ®Google Scholar
• Ohayon MM, Reynolds CFIII. Epidemiological and clinical relevance of insomnia diagnosis algorithms according to the DSM-IV and the International Classification of Sleep Disorders (ICSD). Sleep Med 2009;10(9):952-60
   PubMed Web of Science ®Google Scholar
• Castro LS, Poyares D, Leger D, et al. Objective prevalence of insomnia in the Sao Paulo, Brazil epidemiologic sleep study. Ann Neurol 2013;74(4):537-46
   PubMed Web of Science ®Google Scholar
• National Center for Health Statistics. National Health Interview Survey- Disability Supplement. 1994
   Google Scholar
• Sack RL, Lewy AJ, Blood ML, et al. Circadian rhythm abnormalities in totally blind people: incidence and clinical significance. J Clin Endocrinol Metab 1992;75:127-34
   PubMed Web of Science ®Google Scholar
• Licamele L, Dressman M, Feeney J, Polymeropoulos MH. Pleiomorphic Expression of N24HSWD in the Totally Blind. 26th Annual Meeting of the Associated Professional Sleep Societies L, 2012
   Google Scholar
• Leger D, Guilleminault C, Dreyfus JP, et al. Prevalence of insomnia in a survey of 12,778 adults in France. J Sleep Res 2000;9(1):35-42
   PubMed Web of Science ®Google Scholar
• Flynn-Evans EE, Tabandeh H, Skene DJ, Lockley SW. Circadian rhythm disorders and melatonin production in 127 blind women with and without light perception. J Biol Rhythms 2014;29(3):215-24
   PubMed Web of Science ®Google Scholar
• Leger D, Guilleminault C, Santos C, Paillard M. Sleep/wake cycles in the dark: sleep recorded by polysomnography in 26 totally blind subjects compared to controls. Clin Neurophysiol 2002;113(10):1607-14
   PubMed Web of Science ®Google Scholar
• Emens JS, Laurie AL, Songer JB, Lewy AJ. Non-24-hour disorder in blind individuals revisited: variability and the influence of environmental time cues. Sleep 2013;36(7):1091-100
   PubMed Web of Science ®Google Scholar
• Landmann N, Kuhn M, Piosczyk H, et al. The reorganisation of memory during sleep. Sleep Med Rev 2014;18(6):531-41
   PubMed Web of Science ®Google Scholar
• Rasch B, Born J. About sleep’s role in memory. Physiol Rev 2013;93(2):681-766
   PubMed Web of Science ®Google Scholar
• Diekelmann S, Wilhelm I, Wagner U, Born J. Sleep improves prospective remembering by facilitating spontaneous-associative retrieval processes. PLoS ONE 2013;8(10):e77621
   PubMed Web of Science ®Google Scholar
• St Onge MP, Shechter A. Sleep disturbances, body fat distribution, food intake and/or energy expenditure: pathophysiological aspects. Horm Mol Biol Clin Investig 2014;17(1):29-37
   Google Scholar
• Ingiosi AM, Opp MR, Krueger JM. Sleep and immune function: glial contributions and consequences of aging. Curr Opin Neurobiol 2013;23(5):806-11
   PubMed Web of Science ®Google Scholar
• Knutson KL. Sleep duration and cardio metabolic risk: a review of the epidemiologic evidence. Best Pract Res Clin Endocrinol Metab 2010;731-43
   PubMed Web of Science ®Google Scholar
• Theorell-Haglow J, Berglund L, Janson C, Lindberg E. Sleep duration and central obesity in women - differences between short sleepers and long sleepers. Sleep Med 2012;13(8):1079-85
   PubMed Web of Science ®Google Scholar
• Cappuccio FP, D’Elia L, Strazzullo P, Miller MA. Quantity and quality of sleep and incidence of type 2 diabetes: a systematic review and meta-analysis. Diabetes Care 2010;33(2):414-20
   PubMed Web of Science ®Google Scholar
• Faraut B, Touchette E, Gamble H, et al. Short sleep duration and increased risk of hypertension: a primary care medicine investigation. J Hypertens 2012;30(7):1354-63
   PubMed Web of Science ®Google Scholar
• Paunio T, Korhonen T, Hublin C, et al. Poor sleep predicts symptoms of depression and disability retirement due to depression. J Affect Disord 2014;172C:381-9
   PubMedGoogle Scholar
• Kronholm E, Sallinen M, Suutama T, et al. Self-reported sleep duration and cognitive functioning in the general population. J Sleep Res 2009;18(4):436-46
   PubMed Web of Science ®Google Scholar
• Medical Dictionary of Regulatory Activities. 2014
   Google Scholar
• Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 2011;168(12):1266-77
   PubMed Web of Science ®Google Scholar
• Leger D, Guilleminault C, Defrance R, et al. Prevalence of sleep/wake disorders in persons with blindness. Clin Sci (Lond) 1999;97(2):193-9
   PubMed Web of Science ®Google Scholar
• Ohayon MM. Determining the level of sleepiness in the American population and its correlates. J Psychiatr Res 2012;46(4):422-7
   PubMed Web of Science ®Google Scholar
• Harris IM. Regulatory and ethical issues with dietary supplements. Pharmacotherapy 2000;20(11):1295-302
   PubMed Web of Science ®Google Scholar
• Williamson BL, Tomlinson AJ, Mishra PK, et al. Structural characterization of contaminants found in commercial preparations of melatonin: similarities to case-related compounds from L-tryptophan associated with eosinophilia-myalgia syndrome. Chem Res Toxicol 1998;11(3):234-40
   PubMed Web of Science ®Google Scholar
• Naylor S, Johnson KL, Williamson BL, et al. Structural characterization of contaminants in commercial preparations of melatonin by on-line HPLC-electrospray ionization-tandem mass spectrometry. Adv Exp Med Biol 1999;467:769-77
   PubMed Web of Science ®Google Scholar
• Suhner A, Werner I, Wilde A, Schlagenhauf P. Over-the-counter melatonin--quality or quackery? Pharmazie 1999;54(11):863-4
   PubMed Web of Science ®Google Scholar
• Uchiyama M, Shibui K, Hayakawa T, et al. Larger phase angle between sleep propensity and melatonin rhythms in sighted humans with non-24-hour sleep-wake syndrome. Sleep 2002;25(1):83-8
   PubMed Web of Science ®Google Scholar
• 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(4):312-18
   PubMed Web of Science ®Google Scholar