title: A randomized, double-blind, double-dummy, multicenter, controlled trial on brotizolam intervention in outpatients with insomnia.
abstract: OBJECTIVE
  To investigate the efficacy and safety of brotizolam in outpatients with insomnia.
  
  
  METHODS
  This randomized, double-blind, double-dummy, multicenter, controlled trial recruited 253 outpatients randomized to receive either brotizolam (n = 126) or estazolam (n = 127) for 14 days followed by 1 week of follow-up for rebound detection. Sleep Dysfunction Rating Scale (SDRS) and Clinical General Impression Scale were applied for efficacy evaluation. Safety evaluation was based on data regarding vital signs, physical examination, lab tests, ECG and collection of adverse events.
  
  
  RESULTS
  Full Analyses Set (FAS) and Safety Set (SS) included data of 251 subjects, with 126 from brotizolam group and 125 from estazolam group. Per Protocol Set (PPS) analysis included data of 235 subjects, with 121 and 114 from each group. After 14 days of treatment, there was no difference with statistical significance between the two groups regarding SDRS total score change from baseline. FAS and PPS analysis showed that the brotizolam is non-inferior to estazolam in efficacy evaluation. There was also no difference with statistical significance regarding rebound rate between brotizolam and estazolam group in FAS. The rate of adverse event in two groups was with no statistically significant difference in SS.
  
  
  CONCLUSIONS
  Brotizolam is effective and safe in relieving the symptoms of insomnia.
authors.affiliation: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine , Shanghai , P. R. China.
authors.forename: Xiaolei
authors.initials: X
authors.lastname: Yan
authors.forename: Shuzhen
authors.initials: S
authors.lastname: Huang
authors.forename: Cui
authors.initials: C
authors.lastname: Ma
authors.forename: Yang
authors.initials: Y
authors.lastname: Shen
authors.forename: Niufan
authors.initials: N
authors.lastname: Gu
authors.forename: Haibo
authors.initials: H
authors.lastname: Chen
authors.forename: Wenyuan
authors.initials: W
authors.lastname: Wu
authors.forename: Shunwei
authors.initials: S
authors.lastname: Li
authors.forename: Zhen
authors.initials: Z
authors.lastname: Hong
authors.forename: Huafang
authors.initials: H
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D014151:Anti-Anxiety Agents / Q000627:therapeutic use; D001381:Azepines / Q000494:pharmacology / Q000627:therapeutic use*; D002681:China; D004311:Double-Blind Method; D004949:Estazolam / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014151:Anti-Anxiety Agents; D001381:Azepines; D006993:Hypnotics and Sedatives; D004949:Estazolam; C020960:brotizolam