Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.

It is intended to recruit 240 insomnia outpatients in this study, 120 patients receiving Brotizolam + Estazolam placebo (Test Group) and 120 patients given Estazolam + Brotizolam placebo (Control Group).

Study Hypothesis:

Brotizolam can be safely used in insomnia patients in China. And Brotizolam 0.25mg is non-inferior with Estazolam 1-2mg in treatment of insomnia patients in China

Comparison(s):

Estazolam 1-2mg

Inclusion_Criteria:

Patients will be eligible for enrollment of this study if they meet all of the following criteria:

• Willing and able to provide written informed consent
• Male or female, aged 18 - 65 (including 18 and 65)
• Diagnosed as insomnia by the criteria of CCMD-3:

Exclusion_Criteria:

• Who received any central nervous system drugs within one week before visit 2(baseline)
• Continuous use of hypnotic agents for more than 3 months recently
• History of inefficiency with benzodiazepine-type hypnotics
• Who have a history of obvious hypersensitivity
• Hamilton Depression Rating Scale (HAMD)18
• Who was diagnosed with other mental illness
• With serious diseases of heart, liver and kidney, etc
• Who had sleep apnoea syndrome
• Who had epileptic seizures within one year
• With angle closure glaucoma that is acute or easy to occurred
• Whose AST or ALT values are 2 times of normal upper limit
• Whose Cr or BUN values are 2 times of normal upper limit
• Who are known to be prone to the abuse of alcohol (i.e. history of evidence of acute or chronic abuse), or any other addictive agents
• Who is participating in other clinical trial, or have participated in a clinical study of any other drug in one month prior to visit 2 (baseline). In addition, patients who has been randomized in this trial and then withdrew can not be enrolled again.
• All pregnant, lactational women and women who have the plan of pregnancy.
• Who are unwilling to or not able to complete the whole clinical trial
• Other patients who are unsuitable to be included in the trial judged by investigator