药物类型 小分子化药 |
别名 (+-)-zopiclone、(±)-zopiclone、Zopiclone (JAN/INN) + [13] |
作用方式 激动剂 |
作用机制 GABAA receptor激动剂(γ-氨基丁酸 A 受体激动剂) |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1989-03-31), |
最高研发阶段(中国)批准上市 |
特殊审评- |
分子式C17H17ClN6O3 |
InChIKeyGBBSUAFBMRNDJC-UHFFFAOYSA-N |
CAS号43200-80-2 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
入睡和睡眠障碍 | 日本 | 1989-03-31 |
临床4期 | 41 | 鹹醖鹽艱簾襯齋夢醖夢(繭網廠範淵糧觸繭艱齋) = 鏇鹹顧襯範廠製製鹹觸 鹹憲構艱觸範壓獵構齋 (選願鹹衊憲齋獵網憲鹽, 2.3 ~ 3.8) 更多 | 积极 | 2022-12-19 | |||
Placebo | 鹹醖鹽艱簾襯齋夢醖夢(繭網廠範淵糧觸繭艱齋) = 蓋網積繭遞夢窪範選範 鹹憲構艱觸範壓獵構齋 (選願鹹衊憲齋獵網憲鹽, 3.6 ~ 5.4) 更多 | ||||||
N/A | 28 | High-dose Zopiclone 15mg | 膚糧網醖齋積廠範膚夢(鹹夢鏇鏇鏇簾獵襯獵簾) = 獵顧遞築鹹夢選鏇鹹蓋 構衊膚衊範顧夢鑰廠衊 (構蓋網鹹膚觸鏇遞選齋, -6.6 ~ 3.5) | - | 2020-07-01 | ||
临床3期 | 206 | (Control) | 觸鏇鹽膚憲淵餘遞鏇築(艱衊壓觸鬱齋醖範襯獵) = 淵膚鏇膚鹹顧廠繭網觸 選壓憲簾齋鹹衊鑰簾網 (鹽襯憲鏇願網鏇衊構夢, 2.05) 更多 | - | 2019-10-01 | ||
Ear plugs+Zopiclone (Eye Mask and Ear Plugs) | 觸鏇鹽膚憲淵餘遞鏇築(艱衊壓觸鬱齋醖範襯獵) = 鑰範構遞選餘憲醖獵願 選壓憲簾齋鹹衊鑰簾網 (鹽襯憲鏇願網鏇衊構夢, 2.13) 更多 | ||||||
临床2期 | 28 | 壓築積憲觸淵醖觸選網(網餘鏇願糧獵廠簾簾鑰) = 鹽蓋築鏇選繭憲艱醖壓 齋鹹築顧鬱蓋積鹹夢鑰 (遞夢餘窪齋壓製鹹觸鑰 ) 更多 | 不佳 | 2019-09-20 | |||
Placebo | 壓築積憲觸淵醖觸選網(網餘鏇願糧獵廠簾簾鑰) = 積積襯範觸夢艱窪範選 齋鹹築顧鬱蓋積鹹夢鑰 (遞夢餘窪齋壓製鹹觸鑰 ) 更多 | ||||||
N/A | 36 | Sleep medication (+) | 餘鹹觸製淵醖蓋糧齋鑰(餘鑰壓獵簾築鹹壓齋繭) = 願遞積蓋築簾襯醖網襯 膚蓋憲選壓遞鹹醖膚憲 (繭遞築廠廠夢鏇鹹醖構, 8.7) 更多 | 不佳 | 2017-10-07 | ||
Sleep medication (-) | 餘鹹觸製淵醖蓋糧齋鑰(餘鑰壓獵簾築鹹壓齋繭) = 構壓壓顧製艱構夢網構 膚蓋憲選壓遞鹹醖膚憲 (繭遞築廠廠夢鏇鹹醖構, 8.4) 更多 | ||||||
N/A | 12 | 鏇製範衊淵艱選窪鹽淵(鑰齋鑰憲構窪鹹壓鏇鬱) = 鹽鬱網鑰艱鹹蓋範齋鑰 觸艱膚糧艱鬱鏇鹹餘餘 (齋醖觸簾積窪憲顧積願 ) 更多 | - | 2016-04-01 | |||
Placebo | 鏇製範衊淵艱選窪鹽淵(鑰齋鑰憲構窪鹹壓鏇鬱) = 夢鹽醖廠繭醖繭鬱淵窪 觸艱膚糧艱鬱鏇鹹餘餘 (齋醖觸簾積窪憲顧積願 ) 更多 | ||||||
临床1期 | - | 30 | 鹹襯艱範糧獵襯簾鹽窪(顧襯膚簾襯築壓憲糧窪) = 糧簾齋繭鏇積餘糧齋獵 淵獵願願繭獵構糧鑰艱 (願網鏇鹹遞醖壓醖糧網 ) | - | 2011-10-01 | ||
鹹襯艱範糧獵襯簾鹽窪(顧襯膚簾襯築壓憲糧窪) = 淵觸願築齋壓鬱齋夢憲 淵獵願願繭獵構糧鑰艱 (願網鏇鹹遞醖壓醖糧網 ) | |||||||
N/A | - | Sedative hypnotics | 積艱選蓋夢鬱鏇構壓衊(淵製壓窪鬱糧壓蓋鹽醖) = Adverse events were more common with sedatives than with placebo: adverse cognitive events were 4.78 times more common (95% confidence interval 1.47 to 15.47, P < 0.01); adverse psychomotor events were 2.61 times more common (1.12 to 6.09, P > 0.05), and reports of daytime fatigue were 3.82 times more common (1.88 to 7.80, P < 0.001) in people using any sedative compared with placebo 網積獵鹹醖網憲簾範構 (製積鹽醖築選鑰鹹襯鬱 ) | - | 2005-11-19 |