Sentra PM (a Medical Food) and Trazodone in the Management of Sleep Disorders

Journal of Central Nervous System Disease

Article

William E. Shell Md¹  Stephanie L. Pavlik Cra¹  David S. Silver Md¹  Lawrence A. May Md¹  Debora H. Bullias Bs, Cra, Crc¹ 

[1] All authors are employees or consultants of Targeted Medical Pharma (TMP). TMP is also the institution at which the data was compiled and prepared for this manuscript.;

关键词: medical food;    sleep disorder;    autonomic nervous system;    parasympathetic nervous system;    amino acids;    heart rate variability;    Sentra PM;    trazodone;    depression;    anxiety;   

DOI  :  10.4137/JCNSD.S9381

来源: Sage Journals

【 摘 要 】

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.

【 授权许可】

CC BY-NC   
© 2012 SAGE Publications.

【 图 表 】

Figure 1.