A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food

Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone works better than either product alone. Twenty-six subjects will be randomized to a two week ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four subjects and each subject will give a second blood sample for analysis. On the morning of the 14th day of ingestion the final sleep questionnaires will be completed.

Inclusion criteria

• Males and females over the age of 18 and below age 65.
• Patients with a history of a sleep disturbance with non-restorative sleep defined by perceived increase in sleep latency or morning/daytime grogginess.

Exclusion criteria

• Subjects who have previously taken GABAdone, SentraPM or trazadone.
• Subjects who are currently taking tricyclic anti-depressants.
• Any blood chemistry anomalies the investigator finds that may put the patient at risk or invalidate study results.
• Pregnant or lactating females.
• Subjects with implanted pacemakers or other implanted electrical devices