Safety of estazolam. The United States clinical experience.
The safety profile of estazolam, a new triazolobenzodiazepine hypnotic medication, has been developed in 1,320 normal volunteers and patients with insomnia. No clinically significant effects of estazolam on vital signs or laboratory values were detected. Drug-specific adverse effects such as somnolence, dizziness, hypokinesia, and abnormal coordination occurred, but these are expected extensions of benzodiazepine pharmacologic activity. No consistent effects on psychomotor performance, including memory, were seen at the recommended hypnotic doses in insomniac subjects. These data, combined with the evidence for hypnotic activity, indicate that estazolam is a safe and effective treatment for insomnia.
Pierce
M W
MW
Department of Clinical Research, Abbott Laboratories, Abbott Park, Illinois 60064-3500.
Shu
V S
VS
Groves
L J
LJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004949:Estazolam / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006321:Heart / Q000187:drug effects; D006801:Humans; D008297:Male; D008568:Memory / Q000187:drug effects; D008875:Middle Aged; D010352:Patient Dropouts; D010919:Placebos; D011897:Random Allocation; D012119:Respiration / Q000187:drug effects; D012449:Safety; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D013375:Substance Withdrawal Syndrome; D014481:United States
D014151:Anti-Anxiety Agents; D010919:Placebos; D004949:Estazolam