Department of Error (DOI:10.1016/S0140-6736(08)61812-7);Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials

The Lancet

Volumn 373, Issue 9662, 2009, Pages 482-491

  Rajaratnam, Shantha MW ^a,b,d   Polymeropoulos, Mihael H ^c   Fisher, Dennis M ^e   Roth, Thomas ^f   Scott, Christin ^c   Birznieks, Gunther ^c   Klerman, Elizabeth B ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c Vanda Pharmaceuticals Inc   (United States)

^d MONASH UNIVERSITY   (Australia)

^e P Less Than Company   (United States)

^f HENRY FORD HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MELATONIN; MELATONIN DERIVATIVE; PLACEBO; TASIMELTEON; UNCLASSIFIED DRUG; VEC 162;

ADULT; ARTICLE; CIRCADIAN RHYTHM; CIRCADIAN RHYTHM SLEEP DISORDER; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG CAPSULE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; EVENING DOSAGE; FEMALE; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HORMONE BLOOD LEVEL; HUMAN; INJECTION SITE CONTUSION; INJECTION SITE IRRITATION; INJECTION SITE PAIN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OUTPATIENT DEPARTMENT; PARALLEL DESIGN; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; POLYSOMNOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE BLIND PROCEDURE; SLEEP; SLEEP TIME; SLEEP WAKING CYCLE; SOMNOLENCE; TREATMENT OUTCOME; UNITED STATES;

EID: 59249087280     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(09)60728-5     Document Type: Erratum

References (52)

1. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th edn (2000), American Psychiatric Association, Washington, DC text revision
2. Klein D.C., Moore R.Y., and Reppert S.M. Suprachiasmatic nucleus. The mind's clock (1991), Oxford University Press, New York
3. Lavie P. Ultrashort sleep-waking schedule. III. 'Gates' and 'forbidden zones' for sleep. Electroencephalogr Clin Neurophysiol 63 (1986) 414-425
4. Dijk D.J., and Czeisler C.A. Contribution of the circadian pacemaker and the sleep homeostat to sleep propensity, sleep structure, electroencephalographic slow waves, and sleep spindle activity in humans. J Neurosci 15 (1995) 3526-3538
5. Czeisler C.A., Johnson M.P., Duffy J.F., Brown E.N., Ronda J.M., and Kronauer R.E. Exposure to bright light and darkness to treat physiologic maladaptation to night work. N Engl J Med 322 (1990) 1253-1259
6. Fahey C.D., and Zee P.C. Circadian rhythm sleep disorders and phototherapy. Psychiatr Clin North Am 29 (2006) 989-1007
7. Dijk D.J., Shanahan T.L., Duffy J.F., Ronda J.M., and Czeisler C.A. Variation of electroencephalographic activity during non-rapid eye movement and rapid eye movement sleep with phase of circadian melatonin rhythm in humans. J Physiol 505 (1997) 851-858
8. Lockley S.W., Skene D.J., Tabandeh H., Bird A.C., Defrance R., and Arendt J. Relationship between napping and melatonin in the blind. J Biol Rhythms 12 (1997) 16-25
9. Wyatt J.K., Ritz-de Cecco A., Czeisler C.A., and Dijk D.J. Circadian temperature and melatonin rhythms, sleep, and neurobehavioral function in humans living on a 20-h day. Am J Physiol 277 (1999) R1152-R1163
10. Rajaratnam S.M., Middleton B., Stone B.M., Arendt J., and Dijk D.J. Melatonin advances the circadian timing of EEG sleep and directly facilitates sleep without altering its duration in extended sleep opportunities in humans. J Physiol 561 (2004) 339-351
11. Rajaratnam S.M., Dijk D.J., Middleton B., Stone B.M., and Arendt J. Melatonin phase-shifts human circadian rhythms with no evidence of changes in the duration of endogenous melatonin secretion or the 24-hour production of reproductive hormones. J Clin Endocrinol Metab 88 (2003) 4303-4309
12. Wyatt J.K., Dijk D.J., Ritz-de Cecco A., Ronda J.M., and Czeisler C.A. Sleep-facilitating effect of exogenous melatonin in healthy young men and women is circadian-phase dependent. Sleep 29 (2006) 609-618
13. Liu C., Weaver D.R., Jin X., et al. Molecular dissection of two distinct actions of melatonin on the suprachiasmatic circadian clock. Neuron 19 (1997) 91-102
14. Reppert S.M. Melatonin receptors: molecular biology of a new family of G protein-coupled receptors. J Biol Rhythms 12 (1997) 528-531
15. Naylor S., and Gleich G.J. Over-the-counter melatonin products and contamination. Am Fam Physician 59 (1999) 287-288 284
16. Williamson B.L., Tomlinson A.J., Mishra P.K., Gleich G.J., and Naylor S. 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 11 (1998) 234-240
17. Arendt J., Bojkowski C., Folkard S., et al. Some effects of melatonin and the control of its secretion in humans. Ciba Found Symp 117 (1985) 266-283
18. Dollins A.B., Zhdanova I.V., Wurtman R.J., Lynch H.J., and Deng M.H. Effect of inducing nocturnal serum melatonin concentrations in daytime on sleep, mood, body temperature, and performance. Proc Natl Acad Sci USA 91 (1994) 1824-1828
19. Dijk D.J., Roth C., Landolt H.P., et al. Melatonin effect on daytime sleep in men: suppression of EEG low frequency activity and enhancement of spindle frequency activity. Neurosci Lett 201 (1995) 13-16
20. Cajochen C., Krauchi K., von Arx M.A., Mori D., Graw P., and Wirz-Justice A. Daytime melatonin administration enhances sleepiness and theta/alpha activity in the waking EEG. Neurosci Lett 207 (1996) 209-213
21. Zhdanova I.V., Wurtman R.J., Morabito C., Piotrovska V.R., and Lynch H.J. Effects of low oral doses of melatonin, given 2-4 hours before habitual bedtime, on sleep in normal young humans. Sleep 19 (1996) 423-431
22. Hughes R.J., and Badia P. Sleep-promoting and hypothermic effects of daytime melatonin administration in humans. Sleep 20 (1997) 124-131
23. Lavie P. Melatonin: role in gating nocturnal rise in sleep propensity. J Biol Rhythms 12 (1997) 657-665
24. Stone B.M., Turner C., Mills S.L., and Nicholson A.N. Hypnotic activity of melatonin. Sleep 23 (2000) 663-669
25. Roth T., Stubbs C., and Walsh J.K. 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 (2005) 303-307
26. Erman M., Seiden D., Zammit G., Sainati S., and Zhang J. An efficacy, safety, and dose-response study of ramelteon in patients with chronic primary insomnia. Sleep Med 7 (2006) 17-24
27. Sack R.L., Brandes R.W., Kendall A.R., and Lewy A.J. Entrainment of free-running circadian rhythms by melatonin in blind people. N Engl J Med 343 (2000) 1070-1077
28. Lockley S.W., Skene D.J., James K., Thapan K., Wright J., and Arendt J. Melatonin administration can entrain the free-running circadian system of blind subjects. J Endocrinol 164 (2000) R1-R6
29. 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 (2006) 385-393
30. Arendt J. Does melatonin improve sleep? Efficacy of melatonin. BMJ 332 (2006) 550
31. Herxheimer A., and Petrie K.J. Melatonin for the prevention and treatment of jet lag. Cochrane Database Syst Rev (2002) CD001520.
32. 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 20 (2005) 1151-1158
33. Erman M.K., Erwin C.W., Gengo F.M., et al. Comparative efficacy of zolpidem and temazepam in transient insomnia. Hum Psychopharmacol 16 (2001) 169-176
34. Walsh J.K., Schweitzer P.K., Sugerman J.L., and Muehlbach M.J. Transient insomnia associated with a 3-hour phase advance of sleep time and treatment with zolpidem. J Clin Psychopharmacol 10 (1990) 184-189
35. Walsh J.K., Deacon S., Dijk D.J., and Lundahl J. The selective extrasynaptic GABA A agonist, gaboxadol, improves traditional hypnotic efficacy measures and enhances slow wave activity in a model of transient insomnia. Sleep 30 (2007) 593-602
36. Workers on flexible and shift schedules. Bureau of Labor Statistics, US Department of Labor, July 1, 2005. http://www.bls.gov/news.release/flex.toc.htm (accessed Jan 15, 2008).
37. Horne J.A., and Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol 4 (1976) 97-110
38. Agnew Jr. H.W., Webb W.B., and Williams R.L. The first night effect: an EEG study of sleep. Psychophysiology 2 (1966) 263-266
39. Roth T., Roehrs T., and Vogel G. Zolpidem in the treatment of transient insomnia: a double-blind, randomized comparison with placebo. Sleep 18 (1995) 246-251
40. Duffy J.F., and Dijk D.J. Getting through to circadian oscillators: why use constant routines?. J Biol Rhythms 17 (2002) 4-13
41. Rechtschaffen A., and Kales A. A manual of standardized terminology, techniques and scoring system for sleep stages of human subjects (1968), US Government Printing Office, Washington, DC
42. Klerman E.B., Gershengorn H.B., Duffy J.F., and Kronauer R.E. Comparisons of the variability of three markers of the human circadian pacemaker. J Biol Rhythms 17 (2002) 181-193
43. Santhi N., Horowitz T.S., Duffy J.F., and Czeisler C.A. Acute sleep deprivation and circadian misalignment associated with transition onto the first night of work impairs visual selective attention. PLoS ONE 2 (2007) e1233
44. Sumova A., and Illnerova H. Melatonin instantaneously resets intrinsic circadian rhythmicity in the rat suprachiasmatic nucleus. Neurosci Lett 218 (1996) 181-184
45. Krauchi K., Cajochen C., Mori D., Graw P., and Wirz-Justice A. Early evening melatonin and S-20098 advance circadian phase and nocturnal regulation of core body temperature. Am J Physiol 272 (1997) R1178-R1188
46. Cajochen C., Kräuchi K., Möri D., Graw P., and Wirz-Justice A. Early evening melatonin and S-20098 advance circadian phase and nocturnal regulation of core body temperature. Am J Physiol 272 (1997) 1189-1196
47. Deacon S., and Arendt J. Melatonin-induced temperature suppression and its acute phase-shifting effects correlate in a dose-dependent manner in humans. Brain Res 688 (1995) 77-85
48. Cajochen C., Kräuchi K., and Wirz-Justice A. The acute soporific action of daytime melatonin administration: effects on the EEG during wakefulness and subjective alertness. J Biol Rhythms 12 (1997) 636-643
49. Graw P., Werth E., Kräuchi K., et al. Early morning melatonin administration impairs psychomotor vigilance. Behav Brain Res 121 (2001) 167-172
50. Zammit G., Erman M., Wang-Weigand S., et al. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. J Clin Sleep Med 3 (2007) 495-504
51. US Bureau of Transportation Statistics. Schedule T-100 Market and segment. http://www.bts.gov/ (accessed July 22, 2008).
52. Rajaratnam S.M., and Arendt J. Health in a 24-h society. Lancet 358 (2001) 999-1005