title: Sentra PM (a Medical Food) and Trazodone in the Management of Sleep Disorders.
abstract: Sleep disorders are a common and poorly treated disease state. This double blind, four arm placebo-controlled, randomized trial compared (1) low dose trazodone, (2) Sentra PM, a neurotransmitter based medical food, (3) the joint administration of trazodone and the medical food Sentra PM and (4) placebo. There were 111 subjects studied in 12 independent sites. Subjects underwent baseline screening, informed consent and an initial sleep questionnaire. After 14 days subjects underwent a second evaluation by questionnaire. At baseline and Day 14 the subjects underwent 24 hour ECG recordings that were analyzed in the frequency domain of heart rate variability. The specific high frequency parasympathetic autonomic nervous system activity was analyzed. The primary endpoints were sleep latency and parasympathetic autonomic nervous system improvement in sleeping hours. The results showed improvement in sleep latency for the Sentra PM and combination of Sentra PM and trazodone (-41 and -56 minutes P < 0.001). There was an improvement in quality of sleep for the amino acid formulation Sentra PM and the combination (3.86 and 6.48 Likert units on a 10 point scale P < 0.001). There was an activation of circadian activity percent at night in the medical food and combination groups while there was no change in parasympathetic activity in either the placebo or trazodone group. These data indicate that Sentra PM can improve the quality of sleep, the response to trazodone as a sleep medication and parasympathetic autonomic nervous system activity.
authors: William E
authors: WE
authors: Shell
authors: Lawrence A
authors: LA
authors: May
authors: Debora H
authors: DH
authors: Bullias
authors: Stephanie L
authors: SL
authors: Pavlik
authors: David S
authors: DS
authors: Silver
keywords: Sentra PM; amino acids; anxiety; autonomic nervous system; depression; heart rate variability; medical food; parasympathetic nervous system; sleep disorder; trazodone
references: Neurology. 1966 Nov;16(11):1053-63
references: 5950916
references: Exp Anim. 2002 Jan;51(1):1-7
references: 11871145
references: Sleep Med Rev. 2011 Aug;15(4):269-81
references: 21459634
references: Am J Med. 2004 Oct 1;117(7):469-78
references: 15464703
references: Semin Neurol. 2009 Sep;29(4):277-96
references: 19742406
references: Sleep Med Rev. 2011 Jun;15(3):139-42
references: 21482156
references: Physiol Behav. 2002 Mar;75(3):267-70
references: 11897251
references: Sleep. 2000 Feb 1;23 Suppl 1:S23-30; discussion S36-8
references: 10755805
references: Obes Res. 2001 Sep;9(9):544-51
references: 11557835
references: J Cardiovasc Electrophysiol. 2003 Aug;14(8):791-9
references: 12890036
references: J Sleep Res. 2001 Dec;10(4):253-64
references: 11903855
references: Handb Clin Neurol. 2011;98:151-71
references: 21056185
references: Experientia. 1983 Jun 15;39(6):551-8
references: 6343111
references: Acta Physiol Scand. 2001 Dec;173(4):409-17
references: 11903133
references: Lancet. 2001 Sep 1;358(9283):696-701
references: 11551575
references: Ind Health. 2002 Jul;40(3):254-9
references: 12141373
references: Adv Neuroimmunol. 1995;5(2):189-200
references: 7496612
references: Sleep. 2004 Jun 15;27(4):811-20
references: 15283019
references: J Psychiatr Res. 2005 Mar;39(2):151-9
references: 15589563
references: Am J Ther. 2010 Mar-Apr;17(2):133-9
references: 19417589
references: Behav Brain Res. 2011 Aug 10;221(2):499-504
references: 21238497
references: Sleep. 2008 May;31(5):673-90
references: 18517037
references: Behav Sleep Med. 2010;8(2):90-104
references: 20352545
references: J Physiol Anthropol Appl Human Sci. 2002 May;21(3):159-65
references: 12148458
references: J Neuropathol Exp Neurol. 2011 Apr;70(4):243-52
references: 21412175
references: J Clin Endocrinol Metab. 1993 May;76(5):1160-4
references: 8496306
references: Mol Aspects Med. 1983;6(2):101-97
references: 6371429
references: Am J Ther. 2012 Mar;19(2):108-14
references: 20861716
references: Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):24-7
references: 19904199
references: Am J Cardiol. 2008 Jun 2;101(11A):89E-103E
references: 18514634
references: J Clin Psychiatry. 2001;62 Suppl 10:33-8
references: 11388589
references: J Clin Pharm Ther. 2002 Apr;27(2):85-92
references: 11975691
references: Chest. 2009 Feb;135(2):563-572
references: 19201722
references: Acta Neurol (Napoli). 1980 Apr;2(2):86-93
references: 6967250
references: Neuropsychopharmacology. 2002 Nov;27(5):843-51
references: 12431858
references: Experientia. 1984 Apr 15;40(4):309-38
references: 6370714
references: Anaesthesia. 2001 May;56(5):424-8
references: 11350326
references: Ann Rheum Dis. 2002 Mar;61(3):232-6
references: 11830428
references: Acta Physiol Hung. 2001;88(3-4):219-30
references: 12162580
references: Life Sci I. 1971 Jul 1;10(13):735-44
references: 5142954
references: JAMA. 2003 Apr 9;289(14):1820-5
references: 12684361
references: Brain Dev. 1986;8(4):469-73
references: 3541663