Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia

Exclusion Criteria

• •Having any medical conditions including diabetes, cardiovascular disease, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric (including depression), immunologic, hematologic, gastrointestinal or metabolic disease requiring medical treatment that would preclude participation into the study in the judgment of the investigator/sub-investigator
• •Having ingested any pharmaceutical or over-the-counter sleep product within 72 hours of dosing as well as 72 hours prior to the Day 90 visit.
• •Taking any medication that can yield a moderate to major drug interaction with propofol including those with CNS (central nervous system)-depressant effects
• •Having had a history of any medical or surgical procedure that would preclude participation into the study in the judgment of the investigator/sub-investigator
• •Being pregnant, planning on becoming pregnant, breast feeding or unwilling to use a medically acceptable form of birth control during the study (with at least one acceptable barrier for a period of one month prior to the beginning of the study until at least three months after study completion) or are surgically sterile or postmenopausal (at least 12 months without a period).
• •Having a systolic blood pressure \>160 mmHg, diastolic blood pressure \>90 mmHg, or blood pressure that would preclude participation in the judgment of the investigator/sub-investigator
• •Having a previous history of abnormal screening laboratory test values: bilirubin \> 2 x ULN (upper limit of normal), AST(aspartate aminotransferase) and ALT (alanine aminotransferase) \> 2 x ULN (upper limit of normal), serum creatinine \> 1.5 mg/dl, fasting blood glucose below 85mg/dl or above 110 mg/dl, calcium level \< 8.6 mg/dl and triglycerides \>200.0mg/dl.
• •Any type of active malignancy (except non-melanomatous skin malignancies) within the past 5 years
• •History of known or suspected substance abuse
• •Currently consume more than 7 standard alcoholic drinks per week and unable to refrain from consuming an alcoholic beverage during the course of the study dosing period.
• •Currently consume more than 14 caffeinated beverages per week and unable to refrain from consuming a caffeinated beverage within 8 hours prior to dosing.
• •History of allergy to any anesthetic, eggs, egg products, soybeans or soy products as well as hypersensitivity to Propofol or any of its components
• •Unable to avoid engaging in a hazardous occupation requiring complete mental alertness and/or motor coordination after receiving the study product.
• •Participation in another study within 30 days prior to dosing.
• •Donated blood within 30 days prior to dosing.
• •Illness within five days prior to dosing
• •Having a pacemaker or any internal medical device
• •In the opinion of the investigator, not suitable for entry into the study.