佐匹克隆片说明书
佐匹克隆片的用法
佐匹克隆片的用法佐匹克隆片是一种抗生素药物,可以治疗多种细菌感染疾病。
该药物的主要成分是氯霉素,它可以通过干扰细菌的蛋白质合成来杀死和控制细菌。
佐匹克隆片广泛应用于治疗上呼吸道感染、皮肤感染、泌尿生殖系统感染等疾病。
佐匹克隆片的使用方法佐匹克隆片通常口服使用,一般是每日三次,每次1-2片,具体剂量应根据病情和医生的建议来确定。
患者在服用时应该按照医生的嘱咐来使用,并按时完成疗程。
一般而言,佐匹克隆片治疗轻度疾病需要7-10天,而严重疾病需要2-4周的治疗时间。
注意事项出现下列情况应及时告知医生:过敏反应(如荨麻疹、皮疹、呼吸困难等)、恶心、呕吐、腹泻、腹部不适、口干、口苦等不适症状。
同时,患者在使用佐匹克隆片时,也需要注意以下几点:1.不要过量服用,一定按照医生的指示或者药物说明书的用法用量进行使用。
2.具有肝肾功能异常或疾病、贫血等患者在使用该药物时应该特别小心,以免加重病情。
3.佐匹克隆片可能会影响对机动车的驾驶技能,因此在使用这些药物时,遵循医生的建议,避免开车或机器操作。
4.佐匹克隆片是一种处方药,只能在医生的处方下购买和使用。
5.不要将佐匹克隆片与其他药物一起使用,应避免饮酒或吸烟。
佐匹克隆片的优缺点优点1.佐匹克隆片可以快速并且有效地杀死和控制细菌,用于治疗多种细菌感染性疾病。
2.它能够带来症状快速缓解,让患者在疗程中减轻不适症状。
3.佐匹克隆片副作用较少,可以使用于多种患者,并且不会对人体产生过大的刺激。
缺点1.该药物会影响到身体的自身免疫系统,因而可能增加一些副作用,如口干、口臭等。
2.部分患者在使用佐匹克隆片时,可能会出现过敏反应(如荨麻疹、皮疹、呼吸困难等)。
3.佐匹克隆片不能同时与某些药物一起使用,会产生不利影响,从而增加副作用。
结语佐匹克隆片是一种广泛使用的抗生素药物,能够有效治疗多种细菌感染疾病。
然而,为了确保药物的使用效果,患者需要按照医生的建议使用,并遵守一些注意事项,如不过量使用,不与其他药物混用等。
佐匹克隆说明书
佐匹克隆说明书佐匹克隆说明书第一章:产品介绍佐匹克隆是一种全新的辅助生育技术,旨在帮助那些不同种族、不同年龄、不同性别或身体状况下的个人实现生育愿望。
佐匹克隆是一项经过精心研发的技术,通过科学的方法,使得个体能够再生体细胞,并在实验室中通过特定操作产生复制的胚胎。
这些复制的胚胎最终可以用于助孕或生殖研究。
第二章:使用方法1.准备工作:在使用佐匹克隆之前,用户需要进行全面的体检,并与医生进行咨询确认适用程度。
2.提取体细胞:通过医学操作,从用户体内提取出一部分体细胞。
这些细胞可以来自皮肤、血液等不同组织。
3.克隆过程:提取的体细胞将被送往实验室,进行克隆过程。
该过程是在严格的实验室环境下进行的,并符合伦理道德规范。
4.胚胎培养:在克隆过程完成后,经过一段时间的培养,胚胎会发育到一定程度,并达到适合助孕或生殖研究的要求。
5.助孕或生殖研究:经过医生判断,如果用户适合助孕,则将胚胎植入母体进行孕育。
如果用户选择参与生殖研究,则胚胎将用于科学实验。
6.后续咨询:佐匹克隆过程结束后,用户可与医生进行咨询,并获得恰当的建议和支持。
第三章:注意事项1.佐匹克隆是一项相对复杂的技术,需要密切配合医生进行操作和监控。
2.佐匹克隆的成功率和效果因个体差异而异,不同情况下可能会有不同的结果。
3.佐匹克隆需要遵守伦理道德规范,并受到法律法规的限制。
4.在使用佐匹克隆前,请确保已充分了解该技术的原理、效果、安全性等方面。
5.佐匹克隆的使用可能会涉及一定的费用,用户需要根据自身情况做出决策。
6.佐匹克隆结果并不保证100%的成功率,用户应做好心理准备。
第四章:风险与副作用使用佐匹克隆技术存在一定的风险和副作用,包括但不限于以下几个方面:1.体细胞提取过程可能会对用户身体造成一定创伤和不适。
2.克隆过程中可能会出现技术失败、胚胎发育异常等情况。
3.胚胎植入过程可能会引发一些并发症,如感染、出血等。
4.使用佐匹克隆技术进行生殖研究时,可能会带来一些未知的道德、伦理等问题。
佐匹克隆说明书
佐匹克隆说明书关于《佐匹克隆说明书》,是我们特意为大家整理的,希望对大家有所帮助。
在如今的社会髙速发展趋势,生活的节奏变的越来越快,经常熬夜加班加点,休息不好,它是经常出现的事儿,日常生活不规律性,精神压力过大,压力较为大,生活压力也较为大,非常容易造成人体的各类病症产生。
在其中失眠便是在其中一项,接下去为大伙儿详解佐匹克隆这一药品,期待会对有要求的小伙伴们有协助。
通用名:佐匹克隆胶襄英文名:Zopiclone Capsules拼音字母:Zuopikelong Jiaonang生产成份疫苗佐匹克隆化学名称:6-(5-氯吡啶-2-基)-7-[(4-羟基哌嗪-1-基)羰氧基]-5,6-二氢吡咯[3,4-b]吡嗪-5-酮。
其化学结构式为:化学式:C17H17ClN6O3相对分子质量:388.81生产性状疫苗本产品为胶囊剂,內容物为乳白色或类乳白色颗粒物或粉末状。
生产适应症疫苗失眠抑郁症。
特别是在适用不可以承受次晨残留功效的病人。
生产规格疫苗7.5mg生产使用方法使用量疫苗内服,7.5mg,临睡时服。
老人最开始使用量为3.75mg,临睡时服,仅在必要时服食7.5mg。
生产副作用疫苗与使用量及病人的敏感度相关。
少许思睡、口干舌燥、肌肉无力、忘却、醉态,易过度紧张或精神错乱、易激惹,头痛、困乏。
长期性吃药后忽然断药会出現戒断症状。
可能有比较轻的兴奋、焦虑情绪、肌疼、震颠、反跳性失眠及噩梦、恶心想吐及呕吐,少见偏重的筋挛、肌肉发抖、神智不清模糊不清。
生产忌讳疫苗禁止使用于对本产品过敏症状,失偿还的吸气作用不全病人,重症肌无力、危重症睡眠质量睡眠呼吸暂停综合征病人。
生产常见问题疫苗肌肉无力病人服药时特别注意诊疗监测,吸气作用不全者和肝、肾功能不全者适度调节使用量。
应用本产品时要肯定严禁摄取酒精饮料。
服药時间不适合太长,忽然断药应当心监测,吃药后不适合实际操作机械设备或开车。
生产孕妇及哺乳期间服药疫苗怀孕期间女性谨慎使用。
右佐匹克隆片Eszopiclone-详细说明书与重点
右佐匹克隆片Eszopiclone英文名称: Eszopiclone T ablets【成分】本品的活性成份为右佐匹克隆。
化学名称:(+)-(7S)-6-(5-氯-2-吡啶基)-7-[(4-甲基哌嗪-1-基)甲酰氧基]-5,6-二氢吡咯并[3,4-b]吡嗪-5-酮,化学结构式:【性状】本品为薄膜衣片,除去薄膜衣后显白色或类白色。
【适应症】用于治疗失眠。
【规格】3mg【用法用量】本品应个体化给药,成人推荐起始剂量为1mg。
如有临床需求,剂量可增至2mg或3mg。
某些患者服用2mg或3mg剂量后导致的晨起高血药浓度将会增加次晨宿醉现象发生的风险,即对驾驶或需要精神锐敏的活动的功能的损害(参见【注意事项】)主诉入睡困难的老年患者推荐起始剂量为睡前1mg,必要时可增加到2mg。
睡眠维持障碍的老年患者推荐剂量为入睡前2mg(见注意事项)。
如高脂肪饮食后立刻服用右佐匹克隆有可能会引起药物吸收缓慢,导致右佐匹克隆对睡眠潜伏期的作用降低(见药代动力学)。
特殊人群:严重肝损患者应慎重使用本品,初始剂量为1mg。
合用CYP抑制剂:与CYP3A4强抑制剂合用,本品初始剂量不应大于1mg,必要时可增加至2mg。
考虑到潜在的中枢神经系统抑制协同作用,当与其它中枢神经系统抑制剂合并用药时,可能需要适当调整右佐匹克隆的剂量。
【不良反应】鉴于临床试验是在不同条件下进行的,临床试验中观察到的不良反应发生率不能直接与其他药物临床试验中的发生率比较,也无法直接反映药物实际临床使用中不良反应的发生率。
右佐匹克隆上市前研究中,大约有400名正常受试者参加了临床药理/药代动力学研究,大约1500名患者参加了安慰剂对照的临床有效性研究(相当于大约263例患者暴露年限)。
上市前研究中,右佐匹克隆治疗的条件及疗程差异较大,包括开放试验和双盲试验(类别)、住院病人和门诊病人、长期和短期试验,不良反应是通过收集不良事件,评估体格检查、生命体征、体重、实验室检测,心电图等结果来进行评价的。
佐匹克隆胶囊说明书
佐匹克隆胶囊说明书青尔齐治疗失眠症。
尤其适用于不能耐受次晨残余作用的患者。
佐匹克隆具有催眠、镇静、抗焦虑、肌肉松弛与抗惊厥作用,其催眠作用迅速,并可延长睡眠时间,提高睡眠质量,减少夜间醒觉次数和早醒次数。
下面是店铺整理的佐匹克隆胶囊说明书,欢迎阅读。
佐匹克隆胶囊商品介绍通用名:佐匹克隆胶囊生产厂家: 天津华津制药有限公司批准文号:国药准字H20010680药品规格:7.5mg*12粒药品价格:¥25.7元佐匹克隆胶囊说明书【药品名称】【商品名】青尔齐【通用名】佐匹克隆胶囊【汉语拼音】Zuopikelong Jiaonang【英文名】Zopiclone Capsules【主要成分】佐匹克隆【化学名】6-(5-氯吡啶-2-基)-7-[(4-甲基哌嗪-1-基)【分子式】C17H17ClN6O3【分子量】388.81【性状】青尔齐为胶囊剂,内容物为白色或类白色颗粒。
【适应症】失眠症。
尤其适用于不能耐受次晨残余作用的患者。
佐匹克隆具有催眠、镇静、抗焦虑、肌肉松弛与抗惊厥作用,其催眠作用迅速,并可延长睡眠时间,提高睡眠质量,减少夜间醒觉次数和早醒次数。
【用法用量】口服:7.5mg,临睡前服。
老年人,开始服3.75mg,必要时可加至7.5mg。
肝功不良者用3.75mg。
【不良反应】剂量及患者的敏感性有关。
偶见思睡、口苦、口干、肌无力、遗忘、醉态,有些人出现异常的易恐、好斗、易受刺激或精神错乱、头痛、乏力。
长期服药后突然停药会出现戒断症状(因药物半衰期短故出现较快),可能有较轻的激动、焦虑、肌痛、震颤、反跳性失眠及恶梦、恶心及呕吐,罕见较重的痉挛、肌肉颤抖、神志模糊(往往继发于较轻的症状)。
【禁忌】对青尔齐过敏者、呼吸功能不全者禁用。
【注意事项】1、不良反应有白天嗜睡、头昏、口苦口干、肌无力、健忘、易怒好斗或精神紊乱。
2、长期用药后突然停药可有戒断现象出现,有轻度的激动、焦虑、肌痛、反跳性失眠、恶梦等。
过量可致昏睡或昏迷,但比一般苯二氮类轻,毒性亦小。
右佐匹克隆-处方指南
用法用量
其它警告/注意事项
失眠本身可能是原发性障碍的一项症状,而不是原发性障 碍本身
与其他CNS抑制剂一样,某些患者可能出现异常的思维或 行为的变化(即:抑制作用或脱抑制作用)
某些抑郁患者可能加重自杀观念 仅慎用于呼吸功能受损或阻塞性睡眠呼吸暂停的患者 仅在就寝时服用右佐匹克隆
THANKs
检测
• 对于健康个体,无需检测
副作用
药物怎样引起副作用?
作用于苯二氮卓类受体,次日会产生宿醉反应,引起日间 镇静、遗忘和共济失调
♣右佐匹克隆的长期研究提示:随着时间的延长,未发生明显 的耐药性或依赖性
副作用
特别的副作用?
♣不愉快的味觉 镇静 眩晕 剂量依赖性的遗忘 紧张不安 口干、头痛
用法用量
禁用
已知对右佐匹克隆或佐匹克隆过敏者 使用镇静安眠药物可能发生罕见的血管性水肿,如果涉及
咽喉、声门或喉,可能引起致命的呼吸道阻塞;因此,如 果发生血管性水肿,应停止治疗 服用镇静安眠药物的患者曾报道有:睡眠驾驶和其它的复 杂行为(如:进食、做饭和打电话)
特殊人群
肾功能受损
一般无需调整剂量
用法用量
给药的重要提醒(Biblioteka ) 但剂量>3mg可能有宿醉反应、幻觉或其他CNS不良反应 为了避免记忆问题或宿醉性镇静作用,仅在需要整晚睡眠
时服用右佐匹克隆 最明显的副作用可能是不愉快的味道 其他副作用可能包括:镇静、眩晕、剂量依赖性的遗忘、
紧张不安、口干和头痛
用法用量
过量
较少右佐匹克隆过量的报道,但可能与佐匹克隆过量相似 在佐匹克隆的过量中,报告有罕见的致命性 与佐匹克隆过量相关的症状包括:笨拙、情绪变化、镇静
佐匹克隆片的功效与作用
佐匹克隆片的功效与作用佐匹克隆,即氢化可的松钠片,是一种常用的内分泌类药物。
它的主要成分是氢化可的松钠,具有抑制肾上腺皮质激素分泌的作用。
首先,佐匹克隆片可以用于治疗高血压。
它通过抑制肾上腺皮质激素的分泌,降低血压,减少心脏的负荷,达到治疗高血压的效果。
同时,佐匹克隆片还能减少血管紧张素的释放,促进血管扩张,改善血液循环,降低心脏负荷,从而起到保护心脏的作用。
其次,佐匹克隆片还可以用于治疗高肾素血症。
高肾素血症是一种肾上腺分泌过多肾素的疾病,可以导致高血压以及肾功能不全。
佐匹克隆片能够抑制肾上腺皮质激素的分泌,减少肾素的释放,从而降低肾素血症的程度,缓解高血压等症状。
此外,佐匹克隆片还具有抑制免疫系统的作用。
免疫系统的过度活跃会导致一系列免疫性疾病的发生,如类风湿关节炎、系统性红斑狼疮等。
佐匹克隆片能够抑制免疫系统的反应,减少炎症反应的发生,从而起到治疗这些免疫性疾病的作用。
此外,佐匹克隆片还可以用于治疗哮喘。
哮喘是一种常见的慢性呼吸系统疾病,其主要症状包括喘息、咳嗽和气促。
佐匹克隆片通过抑制肾上腺皮质激素的分泌,减少气道炎症反应,缓解气道痉挛,从而起到控制哮喘症状的作用。
然而,佐匹克隆片也具有一定的副作用和注意事项。
长期使用可能会导致骨质疏松、水钠潴留、糖耐量降低等副作用。
因此,在使用佐匹克隆片时,需要在医生的指导下进行,并且要定期检查肾功能、血压等指标,以及密切关注副作用的出现。
总之,佐匹克隆片是一种常用的内分泌药物,能够通过抑制肾上腺皮质激素的分泌,起到降压、保护心脏、抑制免疫系统和控制哮喘等作用。
但是,在使用过程中还需注意副作用和禁忌症等问题,以确保药物的安全有效使用。
佐匹克隆胶囊说明书介绍
佐匹克隆胶囊说明书介绍
家里老年人上了年纪了之后会有睡眠下降的问题存在,在发现出现睡眠质量差并且伴有肌肉抽搐的时候,需要去通过口服佐匹克隆胶囊来缓解焦虑、在使用佐匹克隆的过程中,特殊人群的服用计量是有一定的规格的,并且服用者还需要去具体的了解一下注意事项,确保每一次服药的安全性。
★不良反应:与剂量及患者的敏感性有关。
偶见思睡、口苦、口干、肌无力、遗忘、醉态,有些人出现异常的易恐、好斗、易受刺激或精神错乱、头痛、乏力。
长期服药后突然停药会出现戒断症状(因药物半衰期短故出现较快),可能有较轻的激动、焦虑、肌痛、震颤、反跳性失眠及恶梦、恶心及呕吐,罕见较重的痉挛、肌肉颤抖、神志模糊(往往继发于较轻的症状)。
★用法用量:口服,1片,临睡时服;老年人最初临睡时服半片,必要时1片;肝功能不全者,服半片为宜
★注意事项:.肌无力患者用药时需注意医疗监护,呼吸功能不全者和肝、肾功能不全者应适当调整剂量。
2.使用本品时应绝对禁止摄入酒精饮料。
3.连续用药时间不宜过长,突然停药可引起停药综合征应谨慎,服药后不宜操作机械及驾车。
★药理作用:本品常规剂量具有镇静催眠和肌肉松弛作用。
其作用于苯二氮卓受体,但结合方式不同于苯二氮卓类药物。
本品为速效催眠药,能延长睡眠时间,提高睡眠质量,减少夜间觉醒和早醒次数。
本品的特点为次晨残余作用低。
★特殊人群服用:儿童注意事项:15岁以下儿童不宜使用本品。
妊娠与哺乳期注意事项孕期妇女慎用。
因本品在乳汁中浓度高,哺乳期妇女不宜应用。
老人注意事项:老年人最初用量为3.75mg,临睡时服,必要时服用7.5mg。
佐匹克隆片Zopiclone-详细说明书与重点
佐匹克隆片Zopiclone英文名称: Zopiclone Tablets【成分】本品主要成份为:佐匹克隆。
【适应症】本品用于各种失眠症。
【规格】75mg【用法用量】1.口服,1片,临睡时服。
2.老年人最初临睡时服半片,必要时1片。
3.肝功能不全者,服半片为宜。
【不良反应】与剂量及患者的敏感性有关。
偶见思睡﹑口苦﹑口干﹑肌无力﹑遗忘﹑醉态,有些人出现异常的易恐﹑好斗﹑易受刺激或精神错乱﹑头痛﹑乏力。
长期服药后突然停药会出现戒断症状(因药物半衰期短故出现较快),可能有较轻的激动﹑焦虑﹑肌痛﹑震颤﹑反跳性失眠及恶梦﹑恶心及呕吐,罕见较重的痉挛,肌肉颤抖,神志模糊(往往继发于较轻的症状)。
【禁忌】禁用于对本品过敏者,失代偿的呼吸功能不全患者,重症肌无力,重症睡眠呼吸暂停综合症患者。
【注意事项】1.肌无力患者用药时需注意医疗监护﹐呼吸功能不全者和肝、肾功能不全者应适当调整剂量。
2.使用本品时应绝对禁止摄入酒精饮料。
3.连续用药时间不宜过长﹐突然停药可引起停药综合征应谨慎﹐服药后不宜操作机械及驾车。
【孕妇及哺乳期妇女用药】孕期妇女慎用。
因本品在乳汁中浓度高,授乳期妇女不宜使用。
【儿童用药】15岁以下儿童不宜使用本品。
【老年用药】未进行该项实验且无可靠参考文献。
【药物相互作用】1.与神经肌肉阻滞药(筒箭毒,肌松药)或其他中枢神经抑制药同服可增强镇静作用。
2.与苯二氮卓类焦虑药和催眠药同服,戒断综合征的出现可增加。
【药理毒理】本品常规剂量具有镇静催眠和肌肉松弛作用。
其作用于苯二氮卓受体,但结合方式不同于苯二氮卓类药物。
佐匹克隆是安全性较高的速效催眠药,能延长睡眠时间,提高睡眠质量,减少夜间觉醒和早醒次数。
本品的特点为次晨残余作用低。
【药代动力学】据资料报道,健康人口服本品生物利用度为80%,口服吸收迅速,1.5~2.0小时后可达血药浓度峰值,给药3.75、7.5和15mg后,分别为30、60和115mg/ml。
佐匹克隆片的功效和副作用
佐匹克隆片的功效和副作用
佐匹克隆片是一种常用的药物,具有多种功效和一些副作用。
以下是关于佐匹克隆片的详细信息:
1. 功效:
- 镇静作用:佐匹克隆片可抑制中枢神经系统的兴奋,它可以安抚情绪,减少紧张和焦虑感。
- 改善睡眠:该药物可帮助改善失眠问题,提高睡眠质量,并延长入睡时间。
- 抗癫痫作用:佐匹克隆片常用于治疗癫痫,对控制癫痫发作具有一定效果。
- 肌肉放松作用:它可以缓解肌肉痉挛和紧张,对于肌肉痛和痉挛相关的疼痛有一定的缓解作用。
2. 副作用:
- 疲劳和嗜睡:佐匹克隆片可能引起疲劳和嗜睡,影响正常的活动和注意力。
- 坠胀和头晕:部分人在服用佐匹克隆片后可能会出现头晕和脑袋沉重的感觉,甚至可以导致坠胀。
- 注意力和记忆力减退:该药物可能影响注意力和记忆力,特别是在刚开始使用时。
- 消化系统问题:偶尔会出现口干、恶心、呕吐、腹泻等消化系统不良反应。
- 过敏反应:有些人可能对佐匹克隆片过敏,表现为皮疹、荨麻疹、呼吸困难等。
请注意,在使用佐匹克隆片之前,应咨询医生的意见,并按照医生的建议正确使用该药物,以避免可能的不良反应和副作用。
艾司佐匹克隆FDA说明书原版
R x only C-IV LUNESTA™ (eszopiclone) TABLETS1 mg,2 mg,3 mgPRESCRIBING INFORMATIONDESCRIPTION:LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methyl- piperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure:3Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).Eszopiclone is formulated as film-coated tablets for oral administration. LUNESTA tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.CLINICAL PHARMACOLOGY:PharmacodynamicsThe precise mechanism of action of eszopiclone as a hypnotic is unknown, but its effect is believed to result from its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors. Eszopiclone is a nonbenzodiazepine hypnotic that is a pyrrolopyrazine derivative of the cyclopyrrolone class with a chemical structure unrelated to pyrazolopyrimidines, imidazopyridines, benzodiazepines, barbiturates, or other drugs with known hypnotic properties.PharmacokineticsThe pharmacokinetics of eszopiclone have been investigated in healthy subjects (adult and elderly) and in patients with hepatic disease or renal disease. In healthy subjects, the pharmacokinetic profile was examined after single doses of up to 7.5 mg and after once-daily administration of 1, 3, and 6 mg for 7 days. Eszopiclone is rapidly absorbed, with a time to peak concentration (t max) of approximately 1 hour and a terminal-phase elimination half-life (t1/2) of approximately 6 hours. In healthy adults, LUNESTA does not accumulate with once-daily administration, and its exposure is dose-proportional over the range of 1 to 6 mg.Absorption And DistributionEszopiclone is rapidly absorbed following oral administration. Peak plasma concentrations are achieved within approximately 1 hour after oral administration. Eszopiclone is weakly bound to plasma protein (52-59%). The large free fraction suggests that eszopiclone disposition should not be affected by drug-drug interactions caused by protein binding. The blood-to-plasma ratio for eszopiclone is less than one, indicating no selective uptake by red blood cells.MetabolismFollowing oral administration, eszopiclone is extensively metabolized by oxidation and demethylation. The primary plasma metabolites are (S)-zopiclone-N-oxide and (S)-N-desmethyl zopiclone; the latter compound binds to GABA receptors with substantially lower potency than eszopiclone, and the former compound shows no significant binding to this receptor. In vitro studies have shown that CYP3A4 and CYP2E1 enzymes are involved in the metabolism of eszopiclone. Eszopiclone did not show any inhibitory potential on CYP450 1A2, 2A6, 2C9,2C19, 2D6, 2E1, and 3A4 in cryopreserved human hepatocytes.EliminationAfter oral administration, eszopiclone is eliminated with a mean t1/2 of approximately 6 hours. Up to 75% of an oral dose of racemic zopiclone is excreted in the urine, primarily as metabolites.A similar excretion profile would be expected for eszopiclone, the S-isomer of racemic zopiclone. Less than 10% of the orally administered eszopiclone dose is excreted in the urine as parent drug.Effect Of FoodIn healthy adults, administration of a 3 mg dose of eszopiclone after a high-fat meal resulted in no change in AUC, a reduction in mean C max of 21%, and delayed t max by approximately 1 hour. The half-life remained unchanged, approximately 6 hours. The effects of LUNESTA on sleep onset may be reduced if it is taken with or immediately after a high-fat/heavy meal.Special PopulationsAgeCompared with non-elderly adults, subjects 65 years and older had an increase of 41% in total exposure (AUC) and a slightly prolonged elimination of eszopiclone (t1/2 approximately 9 hours).C max was unchanged. Therefore, in elderly patients the starting dose of LUNESTA should be decreased to 1 mg and the dose should not exceed 2 mg.GenderThe pharmacokinetics of eszopiclone in men and women are similar.RaceIn an analysis of data on all subjects participating in Phase 1 studies of eszopiclone, the pharmacokinetics for all races studied appeared similar.Hepatic ImpairmentPharmacokinetics of a 2 mg eszopiclone dose were assessed in 16 healthy volunteers and in8 subjects with mild, moderate, and severe liver disease. Exposure was increased 2-fold in severely impaired patients compared with the healthy volunteers. C max and t max were unchanged. The dose of LUNESTA should not be increased above 2 mg in patients with severe hepatic impairment. No dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. LUNESTA should be used with caution in patients with hepatic impairment. (See DOSAGE AND ADMINISTRATION.)Renal ImpairmentThe pharmacokinetics of eszopiclone were studied in 24 patients with mild, moderate, or severe renal impairment. AUC and C max were similar in the patients compared with demographically matched healthy control subjects. No dose adjustment is necessary in patients with renal impairment, since less than 10% of the orally administered eszopiclone dose is excreted in the urine as parent drug.Drug InteractionsEszopiclone is metabolized by CYP3A4 and CYP2E1 via demethylation and oxidation. There were no pharmacokinetic or pharmacodynamic interactions between eszopiclone and paroxetine, digoxin, or warfarin. When eszopiclone was coadministered with olanzapine, no pharmacokinetic interaction was detected in levels of eszopiclone or olanzapine, but a pharmacodynamic interaction was seen on a measure of psychomotor function. Eszopiclone and lorazepam decreased each other’s C max by 22%. Coadministration of eszopiclone 3 mg to subjects receiving ketoconazole 400 mg, a potent inhibitor of CYP3A4, resulted in a 2.2-foldincrease in exposure to eszopiclone. LUNESTA would not be expected to alter the clearance of drugs metabolized by common CYP450 enzymes. (See PRECAUTIONS.)CLINICAL TRIALS:The effect of LUNESTA on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18-86) with chronic and transient insomnia in six placebo-controlled trials of up to 6 months’ duration. Two of these trials were in elderly patients (n=523). Overall, at the recommended adult dose (2-3 mg) and elderly dose (1-2 mg), LUNESTA significantly decreased sleep latency and improved measures of sleep maintenance (objectively measured as wake time after sleep onset [WASO] and subjectively measured as total sleep time).Transient InsomniaHealthy adults were evaluated in a model of transient insomnia (n=436) in a sleep laboratory in a double-blind, parallel-group, single-night trial comparing two doses of eszopiclone and placebo. LUNESTA 3 mg was superior to placebo on measures of sleep latency and sleep maintenance, including polysomnographic (PSG) parameters of latency to persistent sleep (LPS) and WASO.Chronic Insomnia (Adults And Elderly)The effectiveness of LUNESTA was established in five controlled studies in chronic insomnia. Three controlled studies were in adult subjects, and two controlled studies were in elderly subjects with chronic insomnia.AdultsIn the first study, adults with chronic insomnia (n=308) were evaluated in a double-blind, parallel-group trial of 6 weeks’ duration comparing LUNESTA 2 mg and 3 mg with placebo. Objective endpoints were measured for 4 weeks. Both 2 mg and 3 mg were superior to placebo on LPS at 4 weeks. The 3 mg dose was superior to placebo on WASO.In the second study, adults with chronic insomnia (n=788) were evaluated using subjective measures in a double-blind, parallel-group trial comparing the safety and efficacy of LUNESTA 3 mg with placebo administered nightly for 6 months. LUNESTA was superior to placebo on subjective measures of sleep latency, total sleep time, and WASO.In addition, a 6-period cross-over PSG study evaluating eszopiclone doses of 1 to 3 mg, each given over a 2-day period, demonstrated effectiveness of all doses on LPS, and of 3 mg on WASO. In this trial, the response was dose-related.ElderlyElderly subjects (ages 65-86) with chronic insomnia were evaluated in two double-blind, parallel-group trials of 2 weeks’ duration. One study (n=231) compared the effects of LUNESTA with placebo on subjective outcome measures, and the other (n=292) on objective and subjective outcome measures. The first study compared 1 mg and 2 mg of LUNESTA with placebo, while the second study compared 2 mg of LUNESTA with placebo. All doses were superior to placebo on measures of sleep latency. In both studies, 2 mg of LUNESTA was superior to placebo on measures of sleep maintenance.Studies Pertinent To Safety Concerns For Sedative/Hypnotic DrugsCognitive, Memory, Sedative, and Psychomotor EffectsIn two double-blind, placebo-controlled, single-dose cross-over studies of 12 patients each (one study in patients with insomnia; one in normal volunteers), the effects of LUNESTA 2 and 3 mg were assessed on 20 measures of cognitive function and memory at 9.5 and 12 hours after a nighttime dose. Although results suggested that patients receiving LUNESTA 3 mg performed more poorly than patients receiving placebo on a very small number of these measures at 9.5 hours post-dose, no consistent pattern of abnormalities was seen.In a 6-month double-blind, placebo-controlled trial of nightly administered LUNESTA 3 mg,8/593 subjects treated with LUNESTA 3 mg (1.3%) and 0/195 subjects treated with placebo (0%) spontaneously reported memory impairment. The majority of these events were mild in nature (5/8), and none were reported as severe. Four of these events occurred within the first 7 days of treatment and did not recur. The incidence of spontaneously reported confusion in this 6-month study was 0.5% in both treatment arms. In a 6-week adult study of nightly administered LUNESTA 2 mg or 3 mg or placebo, the spontaneous reporting rates for confusion were 0%, 3.0%, and 0%, respectively, and for memory impairment were 1%, 1%, and 0%, respectively. In a 2-week study of 264 elderly insomniacs randomized to either nightly LUNESTA 2 mg or placebo, spontaneous reporting rates of confusion and memory impairment were 0% vs. 0.8% and 1.5% vs. 0%, respectively. In another 2-week study of 231 elderly insomniacs, the spontaneous reporting rates for the 1 mg, 2 mg, and placebo groups for confusion were 0%,2.5%, and 0%, respectively, and for memory impairment were 1.4%, 0%, and 0%, respectively.A study of normal subjects exposed to single fixed doses of LUNESTA from 1 to 7.5 mg using the DSST to assess sedation and psychomotor function at fixed times after dosing (hourly up to 16 hours) found the expected sedation and reduction in psychomotor function. This was maximal at 1 hour and present up to 4 hours, but was no longer present by 5 hours.In another study, patients with insomnia were given 2 or 3 mg doses of LUNESTA nightly, with DSST assessed on the mornings following days 1, 15, and 29 of treatment. While both the placebo and LUNESTA 3 mg groups showed an improvement in DSST scores relative to baseline the following morning (presumably due to a learning effect), the improvement in theplacebo group was greater and reached statistical significance on night 1, although not on nights 15 and 29. For the LUNESTA 2 mg group, DSST change scores were not significantly different from placebo at any time point.Withdrawal-Emergent Anxiety And InsomniaDuring nightly use for an extended period, pharmacodynamic tolerance or adaptation has been observed with other hypnotics. If a drug has a short elimination half-life, it is possible that a relative deficiency of the drug or its active metabolites (i.e., in relationship to the receptor site) may occur at some point in the interval between each night’s use. This is believed to be responsible for two clinical findings reported to occur after several weeks of nightly use of other rapidly eliminated hypnotics: increased wakefulness during the last quarter of the night and the appearance of increased signs of daytime anxiety.In a 6-month double-blind, placebo-controlled study of nightly administration of LUNESTA3 mg, rates of anxiety reported as an adverse event were 2.1% in the placebo arm and 3.7% in the LUNESTA arm. In a 6-week adult study of nightly administration, anxiety was reported as an adverse event in 0%, 2.9%, and 1.0% of the placebo, 2 mg, and 3 mg treatment arms, respectively. In this study, single-blind placebo was administered on nights 45 and 46, the first and second days of withdrawal from study drug. New adverse events were recorded during the withdrawal period, beginning with day 45, up to 14 days after discontinuation. During this withdrawal period, 105 subjects previously taking nightly LUNESTA 3 mg for 44 nights spontaneously reported anxiety (1%), abnormal dreams (1.9%), hyperesthesia (1%), and neurosis (1%), while none of 99 subjects previously taking placebo reported any of these adverse events during the withdrawal period.Rebound insomnia, defined as a dose-dependent temporary worsening in sleep parameters (latency, sleep efficiency, and number of awakenings) compared with baseline following discontinuation of treatment, is observed with short- and intermediate-acting hypnotics. Rebound insomnia following discontinuation of LUNESTA relative to placebo and baseline was examined objectively in a 6-week adult study on the first 2 nights of discontinuation (nights 45 and 46) following 44 nights of active treatment with 2 mg or 3 mg. In the LUNESTA 2 mg group, compared with baseline, there was a significant increase in WASO and a decrease in sleep efficiency, both occurring only on the first night after discontinuation of treatment. No changes from baseline were noted in the LUNESTA 3 mg group on the first night after discontinuation, and there was a significant improvement in LPS and sleep efficiency compared with baseline following the second night of discontinuation. Comparisons of changes from baseline between LUNESTA and placebo were also performed. On the first night after discontinuation of LUNESTA 2 mg, LPS and WASO were significantly increased and sleep efficiency was reduced; there were no significant differences on the second night. On the first night following discontinuation of LUNESTA 3 mg, sleep efficiency was significantly reduced. No other differences from placebo were noted in any other sleep parameter on either the first or second night following discontinuation. For both doses, the discontinuation-emergent effect was mild, had the characteristics of the return of the symptoms of chronic insomnia, and appeared to resolve by the second night after LUNESTA discontinuation.INDICATIONS AND USAGE:LUNESTA is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance.CONTRAINDICATIONS:None known.WARNINGS:Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including LUNESTA. Because some of the important adverse effects of LUNESTA appear to be dose-related, it is important to use the lowest possible effective dose, especially in the elderly (see DOSAGE AND ADMINISTRATION).A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuropsychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thinking, has been reported in association with the use of sedative/hypnotics.It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above are drug-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.Following rapid dose decrease or abrupt discontinuation of the use of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs (see DRUG ABUSE AND DEPENDENCE).LUNESTA, like other hypnotics, has CNS-depressant effects. Because of the rapid onset of action, LUNESTA should only be ingested immediately prior to going to bed or after the patient has gone to bed and has experienced difficulty falling asleep. Patients receiving LUNESTAshould be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination (e.g., operating machinery or driving a motor vehicle) after ingesting the drug, and be cautioned about potential impairment of the performance of such activities on the day following ingestion of LUNESTA. LUNESTA, like other hypnotics, may produce additive CNS-depressant effects when coadministered with other psychotropic medications, anticonvulsants, antihistamines, ethanol, and other drugs that themselves produce CNS depression. LUNESTA should not be taken with alcohol. Dose adjustment may be necessary when LUNESTA is administered with other CNS-depressant agents, because of the potentially additive effects.PRECAUTIONS:GeneralTiming Of Drug AdministrationLUNESTA should be taken immediately before bedtime. Taking a sedative/hypnotic while still up and about may result in short-term memory impairment, hallucinations, impaired coordination, dizziness, and lightheadedness.Use In The Elderly And/Or Debilitated PatientsImpaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. The recommended starting dose of LUNESTA for these patients is 1 mg. (See DOSAGE AND ADMINISTRATION.)Use In Patients With Concomitant IllnessClinical experience with eszopiclone in patients with concomitant illness is limited. Eszopiclone should be used with caution in patients with diseases or conditions that could affect metabolism or hemodynamic responses.A study in healthy volunteers did not reveal respiratory-depressant effects at doses 2.5-fold higher (7 mg) than the recommended dose of eszopiclone. Caution is advised, however, if LUNESTA is prescribed to patients with compromised respiratory function.The dose of LUNESTA should be reduced to 1 mg in patients with severe hepatic impairment, because systemic exposure is doubled in such subjects. No dose adjustment appears necessary for subjects with mild or moderate hepatic impairment. No dose adjustment appears necessary in subjects with any degree of renal impairment, since less than 10% of eszopiclone is excreted unchanged in the urine.The dose of LUNESTA should be reduced in patients who are administered potent inhibitors of CYP3A4, such as ketoconazole, while taking LUNESTA. Downward dose adjustment is alsorecommended when LUNESTA is administered with agents having known CNS-depressant effects.Use In Patients With DepressionSedative/hypnotic drugs should be administered with caution to patients exhibiting signs and symptoms of depression. Suicidal tendencies may be present in such patients, and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.Information For PatientsPatient information is printed at the end of this insert. To assure safe and effective use of LUNESTA, this information and the instructions provided in the patient information section should be discussed with patients.Laboratory TestsThere are no specific laboratory tests recommended.Drug InteractionsCNS-Active DrugsEthanolAn additive effect on psychomotor performance was seen with coadministration of eszopiclone and ethanol 0.70 g/kg for up to 4 hours after ethanol administration.ParoxetineCoadministration of single doses of eszopiclone 3 mg and paroxetine 20 mg daily for 7 days produced no pharmacokinetic or pharmacodynamic interaction.LorazepamCoadministration of single doses of eszopiclone 3 mg and lorazepam 2 mg did not have clinically relevant effects on the pharmacodynamics or pharmacokinetics of either drug. OlanzapineCoadministration of eszopiclone 3 mg and olanzapine 10 mg produced a decrease in DSST scores. The interaction was pharmacodynamic; there was no alteration in the pharmacokinetics of either drug.Drugs That Inhibit CYP3A4 (Ketoconazole)CYP3A4 is a major metabolic pathway for elimination of eszopiclone. The AUC of eszopiclone was increased 2.2-fold by coadministration of ketoconazole, a potent inhibitor of CYP3A4,400 mg daily for 5 days. C max and t1/2 were increased 1.4-fold and 1.3-fold, respectively. Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly.Drugs That Induce CYP3A4 (Rifampicin)Racemic zopiclone exposure was decreased 80% by concomitant useof rifampicin, a potent inducer of CYP3A4. A similar effect would be expected with eszopiclone.Drugs Highly Bound To Plasma ProteinEszopiclone is not highly bound to plasma proteins (52-59% bound); therefore, the disposition of eszopiclone is not expected to be sensitive to alterations in protein binding. Administration of eszopiclone 3 mg to a patient taking another drug that is highly protein-bound would not be expected to cause an alteration in the free concentration of either drug.Drugs With A Narrow Therapeutic IndexDigoxinA single dose of eszopiclone 3 mg did not affect the pharmacokinetics of digoxin measured at steady state following dosing of 0.5 mg twice daily for one day and 0.25 mg daily for the next 6 days.WarfarinEszopiclone 3 mg administered daily for 5 days did not affect the pharmacokinetics of (R)- or (S)-warfarin, nor were there any changes in the pharmacodynamic profile (prothrombin time) following a single 25 mg oral dose of warfarin.Carcinogenesis, Mutagenesis, Impairment Of FertilityCarcinogenesisIn a carcinogenicity study in Sprague-Dawley rats in which eszopiclone was given by oral gavage, no increases in tumors were seen; plasma levels (AUC) of eszopiclone at the highest dose used in this study (16 mg/kg/day) are estimated to be 80 (females) and 20 (males) times those in humans receiving the maximum recommended human dose (MRHD). However, in a carcinogenicity study in Sprague-Dawley rats in which racemic zopiclone was given in the diet, and in which plasma levels of eszopiclone were reached that were greater than those reached in the above study of eszopiclone, an increase in mammary gland adenocarcinomas in females andan increase in thyroid gland follicular cell adenomas and carcinomas in males were seen at the highest dose of 100 mg/kg/day. Plasma levels of eszopiclone at this dose are estimated to be 150 (females) and 70 (males) times those in humans receiving the MRHD. The mechanism for the increase in mammary adenocarcinomas is unknown. The increase in thyroid tumors is thought to be due to increased levels of TSH secondary to increased metabolism of circulating thyroid hormones, a mechanism that is not considered to be relevant to humans.In a carcinogenicity study in B6C3F1 mice in which racemic zopiclone was given in the diet, an increase in pulmonary carcinomas and carcinomas plus adenomas in females and an increase in skin fibromas and sarcomas in males were seen at the highest dose of 100 mg/kg/day. Plasma levels of eszopiclone at this dose are estimated to be 8 (females) and 20 (males) times those in humans receiving the MRHD. The skin tumors were due to skin lesions induced by aggressive behavior, a mechanism that is not relevant to humans. A carcinogenicity study was also performed in which CD-1 mice were given eszopiclone at doses up to 100 mg/kg/day by oral gavage; although this study did not reach a maximum tolerated dose, and was thus inadequate for overall assessment of carcinogenic potential, no increases in either pulmonary or skin tumors were seen at doses producing plasma levels of eszopiclone estimated to be 90 times those in humans receiving the MRHD — i.e., 12 times the exposure in the racemate study. Eszopiclone did not increase tumors in a p53 transgenic mouse bioassay at oral doses up to300 mg/kg/day.MutagenesisEszopiclone was positive in the mouse lymphoma chromosomal aberration assay and produced an equivocal response in the Chinese hamster ovary cell chromosomal aberration assay. It was not mutagenic or clastogenic in the bacterial Ames gene mutation assay, in an unscheduled DNA synthesis assay, or in an in vivo mouse bone marrow micronucleus assay.(S)-N-desmethyl zopiclone, a metabolite of eszopiclone, was positive in the Chinese hamster ovary cell and human lymphocyte chromosomal aberration assays. It was negative in the bacterial Ames mutation assay, in an in vitro32P-postlabeling DNA adduct assay, and in an in vivo mouse bone marrow chromosomal aberration and micronucleus assay.Impairment Of FertilityEszopiclone was given by oral gavage to male rats at doses up to 45 mg/kg/day from 4 weeks premating through mating and to female rats at doses up to 180 mg/kg/day from 2 weeks premating through day 7 of pregnancy. An additional study was performed in which only females were treated, up to 180 mg/kg/day. Eszopiclone decreased fertility, probably because of effects in both males and females, with no females becoming pregnant when both males and females were treated with the highest dose; the no-effect dose in both sexes was 5 mg/kg (16 times the MRHD on a mg/m2 basis). Other effects included increased pre-implantation loss (no-effect dose 25 mg/kg), abnormal estrus cycles (no-effect dose 25 mg/kg), and decreases in sperm number and motility and increases in morphologically abnormal sperm (no-effect dose 5 mg/kg).PregnancyPregnancy Category CEszopiclone administered by oral gavage to pregnant rats and rabbits during the period of organogenesis showed no evidence of teratogenicity up to the highest doses tested (250 and 16 mg/kg/day in rats and rabbits, respectively; these doses are 800 and 100 times, respectively, the maximum recommended human dose [MRHD] on a mg/m2 basis). In the rat, slight reductions in fetal weight and evidence of developmental delay were seen at maternally toxic doses of 125 and 150 mg/kg/day, but not at 62.5 mg/kg/day (200 times the MRHD on a mg/m2 basis). Eszopiclone was also administered by oral gavage to pregnant rats throughout the pregnancy and lactation periods at doses of up to 180 mg/kg/day. Increased post-implantation loss, decreased postnatal pup weights and survival, and increased pup startle response were seen at all doses; the lowest dose tested, 60 mg/kg/day, is 200 times the MRHD on a mg/m2 basis. These doses did not produce significant maternal toxicity. Eszopiclone had no effects on other behavioral measures or reproductive function in the offspring.There are no adequate and well-controlled studies of eszopiclone in pregnant women. Eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Labor And DeliveryLUNESTA has no established use in labor and delivery.Nursing MothersIt is not known whether LUNESTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LUNESTA is administered to a nursing woman.Pediatric UseSafety and effectiveness of eszopiclone in children below the age of 18 have not been established.Geriatric UseA total of 287 subjects in double-blind, parallel-group, placebo-controlled clinical trials who received eszopiclone were 65 to 86 years of age. The overall pattern of adverse events for elderly subjects (median age = 71 years) in 2-week studies with nighttime dosing of 2 mg eszopiclone was not different from that seen in younger adults (see ADVERSE REACTIONS, Table 2). LUNESTA 2 mg exhibited significant reduction in sleep latency and improvement in sleep maintenance in the elderly population.。
右佐匹克隆片详细说明书
右佐匹克隆片说明书通用名称:右佐匹克隆片主要成份:右佐匹克隆。
用法用量:本品应个体化给药,成年人推荐起始剂量为入睡前2mg,由于3mg可以更有效的延长睡眠时间,可根据临床需要起始剂量为或增加到3mg。
主诉入睡困难的老年患者推荐起始剂量为睡前1mg,必要时可增加到2mg、睡眠维持障碍的老年患者推荐剂量为入睡前2mg(见注意事项)低收用致高有隆期睡后。
食会隆起对克导,缓伏克的匹右眠脂可立引物能肪匹用佐潜佐如作饮吸服右药慢刻降(见药代动力学)。
特殊人群:严重肝损患者应慎重使用本品,初始剂量为1mg。
合用CYP抑制剂:与CYP3A4强抑制剂合用,本品初始剂量不应大于1mg,必要时可增加至2mg。
右佐匹克隆片不良反应:主要不良反应为口苦和头晕,其他如瞌睡、乏力、恶心和呕吐等轻度消化系统和中枢神经系统的不良反应一般持续时间短,症状轻微,不会影响受试者的生活和功能,可自行缓解,停药后症状即可消失。
右佐匹克隆片禁忌:对本品及其成分过敏者,失代偿的呼吸功能不全患者,重症肌无力、重症睡眠呼吸暂停综合症患者。
如何摆脱右佐匹克隆片毒副作用我失眠七八年,佐匹克隆从半片加到二片,大概二三个小时才能入睡,整晚能睡三四个小时,西药的副作用特别大,但想停还停不下来,后来听说百艺舒中药可以逐渐减停西药,我就试了一下,先共同吃段时间,当睡眠达到七个小时,睡眠质量满意后,再将佐匹克隆一次停1/4片,半个月为一个周期逐渐减停,方法很科学,很轻松的就将吃了几年的佐匹克隆停掉了,睡眠也一直很好。
右佐匹克隆片注意事项:右佐匹克隆应在临睡前服用。
服用镇静/催眠药物有可能产生短期记忆损伤、幻觉、协调障碍、眩晕和头晕眼花。
孕妇及哺乳期妇女用药本品由于具有适当的亲脂性,容易进入大脑,右佐匹克隆及其代谢产物可部分通过胎盘屏障,同时本品在乳汁中浓度可能较高,因此妊娠妇女及哺乳期妇女慎用此药。
儿童用药有关18岁以下儿童用药的安全性、有效性尚未确立,不推荐服用此药。
佐匹克隆的用法
佐匹克隆的用法佐匹克隆,也被称为左旋酒石酸环丙孕酮,是一种合成雌激素类药物,常用于医疗和研究领域。
它主要应用于人类的垂体功能减退症、停经、多囊卵巢综合症以及促排卵等治疗中。
佐匹克隆也可用于动物实验中模拟雌激素的作用,以及在植物组织培养和生长调节中也有广泛的应用。
本文将为您介绍佐匹克隆的用法和相关信息。
一、佐匹克隆的用法佐匹克隆的用法主要有以下几个方面:1. 医疗用途佐匹克隆在医疗领域主要用于垂体功能减退症、停经、多囊卵巢综合症、促排卵等治疗中。
这些疾病或症状往往与雌激素的水平不平衡有关,佐匹克隆通过模拟雌激素的作用来调节患者体内的激素水平,从而达到治疗效果。
2. 动物实验在动物实验中,佐匹克隆常被用来模拟雌激素的作用。
科研人员可以通过给实验动物注射佐匹克隆,来研究雌激素对生理和病理的影响,以及相关疾病的发病机制。
3. 植物生长调节佐匹克隆也被用于植物组织培养和生长调节中。
通过外源添加佐匹克隆,可以促进植物的生长、增加植株的茎节和叶片数量,从而实现对植物生长过程的调控。
二、佐匹克隆的剂型和剂量1. 剂型佐匹克隆通常以片剂或注射剂的形式供应,片剂用于口服给药,而注射剂则用于肌肉或静脉注射。
2. 剂量根据患者的具体病情和医生的建议,佐匹克隆的剂量会有所不同。
一般来说,医生会根据患者的年龄、体重、病情严重程度等因素来确定合适的剂量。
患者在使用佐匹克隆之前应该仔细阅读药品说明书,遵医嘱使用,严格控制剂量,切勿擅自增减用药。
三、佐匹克隆的不良反应和注意事项1. 不良反应佐匹克隆在使用过程中可能会出现一些不良反应,包括头痛、恶心、疲乏、乳房胀痛等。
少数患者可能会出现过敏反应或严重不良反应,如出血、肝功能异常等。
患者在使用佐匹克隆时应密切关注身体状况,如有不适应立即停药并就医。
2. 注意事项患者在使用佐匹克隆前应告知医生自己的过敏史、疾病史、用药史等相关信息。
女性患者在怀孕或哺乳期间应避免使用佐匹克隆。
对于老年患者和有肝肾功能障碍的患者,使用佐匹克隆时需要格外谨慎。
佐匹克隆片的英文说明书
佐匹克隆片的英文说明书Zopiclone TabletsEnglish Instruction Manual1. IntroductionThank you for choosing Zopiclone Tablets as your preferred medication for the treatment of insomnia. This instruction manual is designed to provide you with all the necessary information regarding the usage, dosage, precautions, and possible side effects of Zopiclone tablets. Please read this manual carefully before using the product to ensure safe and effective use.2. UsageZopiclone tablets are intended for the short-term treatment of insomnia in adults. It belongs to a class of medications called hypnotics, which work by acting on the brain to produce a calming effect, helping individuals fall asleep faster and stay asleep longer. Zopiclone tablets should be taken orally with water, and it is recommended to take it just before bed.3. DosageThe recommended dosage for Zopiclone tablets may vary depending on individual circumstances and response to treatment. The usual starting dose for adults is 7.5mg, taken shortly before bedtime. However, your doctor may prescribe a lower dose (e.g., 3.75mg) for elderly patients or in cases of liver or kidney impairment. It is essential to follow the prescribed dosage and never exceed the recommended amount to avoid potential health risks or side effects.4. Precautions4.1 Medical ConditionsBefore using Zopiclone tablets, inform your doctor or pharmacist if you have any of the following medical conditions:- Allergies or sensitivities to medications- Liver or kidney disease- Breathing difficulties or lung problems- Mental health disorders such as depression or anxiety- History of drug or alcohol addiction4.2 Pregnancy and BreastfeedingZopiclone tablets should not be used during pregnancy or breastfeeding as its effects on unborn babies or infants are not yet fully understood. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor for alternative treatment options.4.3 Driving and Operating MachineryZopiclone may cause drowsiness or dizziness, which can impair your ability to drive or operate machinery safely. It is advised to avoid such activities until you know how you react to the medication. If you experience excessive drowsiness or feel unable to concentrate, avoid driving or operating machinery until these effects subside.4.4 Other MedicationsInform your doctor or pharmacist about any other medications you are currently taking, including prescription drugs, over-the-counter medications, herbal supplements, or vitamins. Some medications may interact with Zopiclone tablets, leading to increased side effects or reduced effectiveness.5. Side EffectsWhile Zopiclone tablets are generally well-tolerated, some individuals may experience side effects. Common side effects include:- Dry mouth- Unpleasant taste in mouth- Drowsiness or dizziness- Headache- Nausea or stomach upsetContact your doctor if these side effects persist or worsen. In rare cases, serious allergic reactions or severe mood changes may occur. Seek immediate medical attention if you experience symptoms such as difficulty breathing, swelling of the face or limbs, or sudden changes in mood or behavior.6. StorageStore Zopiclone tablets in a cool, dry place away from direct sunlight and moisture. Keep it out of reach of children and pets. Do not use the medication if it has expired or shows signs of deterioration. Dispose of unused or expired medication properly according to local regulations.7. ConclusionZopiclone tablets are an effective short-term treatment for insomnia. By following the dosage recommendations, precautions, and understanding possible side effects, you can ensure safe and effective use of this medication. If you have any further questions or concerns, please consult your doctor or pharmacist. Rest well with Zopiclone Tablets and enjoy a good night's sleep.Note: This instruction manual is intended for informational purposes only and should not replace professional medical advice. Always consult your healthcare provider for personalized guidance and recommendations.。
右佐匹克隆片说明书?
右佐匹克隆片说明书?
一、成份性状
右佐匹克隆片是化学片剂,其主要成份是右佐匹克隆,常见的包装规格是铝塑泡罩包装,3毫克*6片*1板*1盒。
二、用法与用量
右佐匹克隆片是个体化给药,具体来说,成年人初始用药的剂量应为睡前2毫克,后期可以加量,但不可超过3毫克。
对于难入睡的老年人来说,初始的用
药剂量应为1毫克,必要的时候可以加至2毫克。
而严重肝病患者需慎重服用本
药,参考初始剂量为1毫克,或咨询医生。
三、怎么减停右佐匹克隆片依赖和副作用
我得病近十年,以前吃二片右佐匹克隆勉强能睡四五个小时,用百艺舒中药先调养睡眠再逐渐减停西药,当睡眠调整到七个小时,睡眠质量自己满意后,再
将右佐匹克隆一次停1/4片,半个月为一个周期逐渐减停,方法很科学很有效,
以前是药越吃越多睡眠越来越差,现在是药越吃越少睡眠越来越好,坚持了四五
个月不仅把吃了几年的二片右佐匹克隆都停掉了,而且睡眠一直维持在近七个小
时的深睡眠,睡得很香甜很舒服。
四、用药禁忌
由于右佐匹克隆片治疗的是失眠,会对神经系统造成影响,因此,大家在服用此药期间应注意一些禁忌。
首先,右佐匹克隆片需在睡前服用。
然后,此药和
其他催眠药物一样,可能会给患者带来协调障碍、眩晕、头晕、眼花等不适症状。
PDF 文件使用 "pdfFactory Pro" 试用版本创建w 。
佐匹克隆片说明书
核准日期:2004年8月27日修改日期:2009年6月17日2009年12月2日2010年1月28日2012年8月28日2013年10月8日2014年11月3日2015年5月21日2016年3月25日2017年5月16日2018年8月8日2020年11月16日2021年11月18日2022年5月31日2022年10月21日佐匹克隆片说明书请仔细阅读说明书并在医师指导下使用【药品名称】通用名称:佐匹克隆片商品名称:忆孟返®/Imovane®英文名称:ZOPICLONE TABLETS汉语拼音:ZUOPIKELONG PIAN【成份】活性成份:佐匹克隆化学名称:6-(5-氯吡啶-2-基)-7-[(4-甲基哌嗪-1-基)羰氧基]-5,6-二氢吡咯[3,4-b]吡嗪-5-酮化学结构式:分子式:C 17H 17O 3N 6Cl分子量:388.8【性状】 本品为白色,椭圆形,有刻痕的片剂。
【适应症】本品仅限应用在成人以下严重睡眠障碍的短期治疗中:- 短暂性失眠症- 短期失眠症【规格】 7.5mg【用法用量】用法: 口服剂量:• 年龄低于65岁的成年人:每日7.5 mg 。
• 年龄高于65岁的老年人:推荐剂量为每日3.75 mg ,经评估必要时可以增加至7.5mg 。
• 肝脏或呼吸功能损害的患者:推荐剂量为每日3.75mg 。
• 肾脏功能不全的患者:推荐起始剂量为每日3.75mg 。
• 超过65岁的人群及高风险人群的最佳剂量为3.75mg 。
NN N OONN C H 3NClO应该始终在最低有效剂量下开始治疗,每日给药剂量不应超过7.5 mg。
应在晚上临睡前服药,按单次摄入剂量服用,同一晚不得再次服用。
本品不推荐用于18岁以下儿童和青少年。
治疗持续时间:与所有催眠药一样,不建议长期使用佐匹克隆。
治疗持续时间应该尽可能短,从数天到4周,包括减药期。
由于滥用和依赖风险会随治疗持续时间的增加而升高,因此在未对患者状况进行重新评估的情况下,不应在超出最长治疗期后延长治疗时间(见【注意事项】)。
佐匹克隆片作用原理
佐匹克隆片作用原理佐匹克隆(Sildenafil),又称为万艾可(Viagra),是一种用于治疗男性勃起功能障碍(ED)的药物。
佐匹克隆片的作用原理主要涉及一种叫做磷酸鸟苷酸环化酶5(PDE5)的酶的抑制。
在正常情况下,当男性受到性刺激时,神经系统会通过一系列复杂的反应使勃起发生。
其中一个关键步骤是血管通过扩张增加血液流量,填满阴茎海绵体,从而产生勃起。
这种血管扩张过程主要是通过一种被称为一氧化氮(NO)的信号分子介导的。
磷酸鸟苷酸环化酶5(PDE5)是一种酶,它在一氧化氮信号分子发挥作用后迅速降解另一种信号分子叫做环磷酸鸟苷酸(cGMP)。
cGMP在血管平滑肌中起着扩张血管的作用。
但由于PDE5酶的作用,cGMP的降解速度快于生成速度,从而导致血管舒张的影响减弱,勃起难以维持。
佐匹克隆片的主要成分佐匹克隆正是作为一种PDE5酶抑制剂,通过抑制PDE5酶的活性来增加cGMP水平,从而增强血管扩张作用。
具体来说,佐匹克隆通过与PDE5酶结合并抑制其活性,使cGMP分解受到抑制,从而延长cGMP在血管平滑肌中的作用时间。
这样一来,血管平滑肌得以更好地放松,血液可以更顺畅地流入阴茎海绵体,帮助男性实现勃起。
需要注意的是,佐匹克隆片并不具有直接的性兴奋作用。
它只能在受到性刺激时发挥作用。
在没有性刺激时,佐匹克隆对勃起功能没有直接影响。
佐匹克隆的作用时间通常为4-6小时,但这并不意味着持续勃起的时间也会如此长。
佐匹克隆只能帮助男性实现勃起,但不能永久维持勃起。
一旦性刺激消失,勃起也会逐渐消退。
此外,佐匹克隆有一些禁忌症,例如,对成分过敏、心血管疾病、严重肝脏或肾脏问题等,都应禁止使用该药物。
同时,佐匹克隆不应与一些药物,特别是含有硝酸酯类的药物同时使用,因为这可能导致严重的血压下降。
奥佑静(右佐匹克隆片)产品简介
五、处方资料 规格:3mg*7片
✓口服,临睡前即时服用(本品应个体化给药)
成年人(非老年)
入睡困难老年人
睡眠维持困难老年人
肝损患者
孕妇
特
哺乳期妇女
殊
对该药及其成分过敏者
人
群
失代偿的呼吸功能不全患者
重症肌无力
重症睡眠呼吸暂停综合征患者
注意
慎用 慎用 慎用 禁用 禁用 禁用 禁用
药物
三唑仑 咪达唑仑 氯硝西泮 氟西泮 硝西泮 地西泮 阿普唑仑 艾司唑仑 劳拉西泮
右佐匹克隆 佐匹克隆 扎来普隆 唑吡坦
宿醉效果 失眠反跳
0 0 +~++ +~++ +++ ++
0
+++ +++ ++~+++
0a 0a ++ + + +
0
0
++
++
无资料
0
0
0
耐受性
+++ +++ ++~+++
+ + + + + +
右佐匹克隆片
简单介绍
目录
一. 右佐匹克隆简介; 二. 右佐匹克隆药代动力学特征; 三. 与其他镇静催眠药物对比; 四. 指南推荐; 五. 处方资料; 六. 右佐匹克隆小结; 七. 2017年右佐匹克隆变更为医保乙类。
益气安神片
右佐匹克隆
【药品名称】
通用名称:右佐匹克隆
英文名称:Dexzopiclone
【适应症】
用于治疗失眠。
【禁忌】
1.对本品及其成分过敏者,失代偿的呼吸功能不全患者,重症肌无力、重症睡眠呼吸暂停综合症患者禁用;
2.18岁以下及孕妇、哺乳期者慎用。
【注意事项】
1.服药时间右佐匹克隆应在临睡前服用;
2.服用镇静/催眠药物有可能产生短期记忆损伤、幻觉、协调障碍、眩晕和头晕眼花;
3.老年和/或虚弱患者使用老年患者和/或虚弱患者使用镇静/催眠药物应考虑到重复使用或对药物敏感引起的运动损伤和/或认知能力损伤,对于此类患者推荐起始剂量为1mg。
【特殊人群用药】
儿童注意事项:
18岁以下慎用。
妊娠与哺乳期注意事项:
孕妇、哺乳期者慎用。
【批准文号】
国药准字H20100073
【生产企业】
企业名称:成都弘达药业有限公司
生产地址:成都市双流县东升镇,彭州市天彭镇花龙路89号。
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核准日期:2004年8月27日修改日期:2009年6月17日2009年12月2日2010年1月28日2012年8月28日 2013 年10月8 日2014年11月03日佐匹克隆片说明书请仔细阅读说明书并在医师指导下使用【药品名称】通用名称:佐匹克隆片商品名称:忆孟返®/Imovane ®英文名称: ZOPICLONE TABLETS汉语拼音:ZUOPIKELONG PIAN【成份】活性成份:佐匹克隆化学名称: 6-(5-氯吡啶-2-基)-7-[(4-甲基哌嗪-1-基)羰氧基]-5,6-二氢吡咯[3,4-b]吡嗪-5-酮。
化学结构式:分子式:C 17H 17O 3N 6Cl分子量:388.8【性状】本品为白色,椭圆形,有刻痕的片剂。
【适应症】 NNNOON N C H 3NClO本品仅限应用在以下严重睡眠障碍的治疗中:- 短暂性失眠症- 短期失眠症【规格】 7.5mg【用法用量】用法: 口服剂量应该始终在最低有效剂量下开始治疗,而且不应该超过最高给药剂量。
本品应该在晚上临睡前服药。
通常的给药剂量如下所示:∙年龄低于65岁的成年人:每日7.5 mg。
∙年龄大于65岁的老年患者:推荐的给药剂量为每日3.75 mg;7.5 mg的给药剂量仅应该在例外的情况下应用。
∙肝脏或呼吸功能损害的患者:推荐剂量是每天1/2片。
(参见【药代动力学】)。
∙肾脏功能不全的患者:推荐起始剂量是每天1/2片。
(参见【药代动力学】)。
在任何情况下,本品的每日给药剂量均不应该超过7.5 mg。
治疗持续时间治疗持续时间应该尽可能短,从数天到4周,包括减药期(参见【注意事项】)。
必须将治疗持续时间告知患者:∙对于短暂性失眠症而言,治疗持续2 -5 天(比如,由旅行导致的失眠症)。
∙对于短期失眠症而言,治疗持续2 - 3 周(比如,由于发生严重事件而导致的失眠症)在一些情况下,可能有必要延长治疗持续时间,以至于超过推荐的治疗时间。
这需要对患者的状态反复进行精确的评估。
【不良反应】适用时使用如下CIOMS频率分级:非常常见≥10 %;常见≥1并且<10 %;不常见≥0.1并且<1 %;罕见≥ 0.01并且<0.1 %;非常罕见<0.01 %,未知(不能从现有数据评价)。
精神异常不常见:梦魇、激越罕见:精神错乱状态、性欲障碍、易激惹、攻击、幻觉未知:多动、妄想、愤怒、行为异常(可能与遗忘症有关)以及梦游症(参见【注意事项】)、依赖、戒断综合征神经系统异常常见:味觉障碍(口苦)、嗜睡(残留症状)不常见:头晕、头痛罕见:顺行性遗忘未知:共济失调皮肤和皮下组织异常罕见:皮疹、瘙痒症眼部异常未知:复视免疫系统异常非常罕见:血管性水肿、过敏性反应胃肠道异常常见:口干,不常见:恶心未知:消化不良肝胆异常非常罕见:转氨酶升高和/或血碱性磷酸酶升高(轻度至中度)肌肉骨骼和结缔组织异常未知:肌无力一般情况和给药部位异常不常见:疲劳损伤、中毒和手术并发症罕见:跌倒(主要发生于老年患者)(参见【用法用量】)佐匹克隆停药有戒断综合征的报道(参见【注意事项】)。
戒断综合征的表现各异,可包括反跳性失眠、肌肉痛、焦虑、震颤、出汗、激动、意识错乱、头痛、心悸、心动过速、谵妄、梦魇、易激惹。
在重度病例中可能出现下述症状:现实解体,人格解体,听觉过敏,四肢麻木刺痛,对光、噪声和身体接触产生超敏反应,幻觉。
在非常罕见的病例,可发生癫痫发作。
【禁忌】有以下情况时禁用此药:-对佐匹克隆或任何其它成份过敏的患者-肌无力患者-严重的呼吸功能不全患者-睡眠呼吸暂停综合症患者-严重的急性或慢性肝脏功能衰竭患者(由于存在发生肝性脑病的危险性)-对谷蛋白过敏或不耐受的患者(因为该药物中含有小麦淀粉[谷蛋白])【注意事项】特别警告需要对合并疾病进行评估(需要进行共病诊断评估)由于睡眠障碍可能是躯体和/或精神病症的首发症状,因此只有对患者进行仔细的评估后才可以对症治疗失眠。
经过7-10天治疗后失眠仍无缓解,表明存在原发性精神和/或内科疾病,应该对其进行评估。
失眠加重或出现新的思维或行为异常可能是由一种未被确诊的精神或身体病症引起的。
这些发现是在服用镇静/催眠药物(包括佐匹克隆片)治疗的过程中出现的。
由于佐匹克隆的一些主要不良反应显示与剂量相关,因此尽可能使用最低的有效剂量(尤其是在老年人服用时)十分重要(参见用法用量)。
严重过敏性及类过敏反应极少有患者第一次或随后服用包括佐匹克隆片在内的镇静—催眠药物后会发生累及舌头、声门或喉的血管性水肿的病例报道。
部分患者会出现其他一些提示有过敏性反应的症状,如呼吸困难、喉关闭或恶心和呕吐。
部分患者需要在急诊科接受治疗。
如果血管性水肿累及舌头、声门或喉,患者可能会发生致命性气道阻塞。
服用佐匹克隆后发生血管性水肿的患者不能再次服用该药物。
异常的思维和行为改变已有报道多种异常的思维和行为改变与使用镇静/催眠药物有关。
(精神/行为)抑制作用下降(例如,出现与性格不符的攻击性和外向性)可能是部分这些改变的特征,这与酒精及其他中枢神经系统抑制剂导致的效应相似。
其他一些报道的行为改变包括怪异行为、激动、幻觉和人格解体。
复杂行为,例如“梦游驾驶症”(即服用镇静-催眠药物后尚未完全醒来时驾车,醒来后却忘了发生过这件事)也有报道。
从未服用或服用过镇静-催眠药物的人均可发生这些事件。
尽管仅服用治疗剂量的佐匹克隆片即可发生如梦游驾驶症等行为,但是在服用佐匹克隆片的同时饮酒及服用其他中枢神经系统抑制剂似乎会增加发生这些行为的风险,而佐匹克隆片的剂量超过最大推荐剂量时也会导致发生这些行为的风险增加。
由于这些行为对患者和社区有风险,对于报道发生“驾驶梦游症”的患者,应该强烈考虑停用佐匹克隆片。
还有报道,服用镇静-催眠药物后没有完全清醒的患者发生了其它复杂行为(例如准备食物和吃食物、打电话或发生性行为)。
如发生梦游驾驶症一样,患者通常记不起发生过这些事情。
健忘症及其他神经精神症状可能会在无法预测的情况下出现。
与其它催眠药一样,佐匹克隆不用于抑郁症治疗,并可掩盖其症状。
有报道指出原发性抑郁的患者抑郁加重,包括有自杀想法和行为(包括自杀成功)与服用镇静-催眠药物有关。
很难确定以上列出的特殊异常行为是由药物引起、自发性或是潜在精神疾病或躯体疾病引起的。
既是如此,仍要对任何新出现的令人关注的行为体征或症状进行认真而迅速的评估。
撤药反应有报道指出迅速减少镇静-催眠药物的剂量或突然停药出现的体征和症状与停用其他中枢神经系统抑制药物后出现的体征和症状相似。
中枢神经系统抑制效应与其他催眠药物一样,佐匹克隆片也有中枢神经系统抑制效应。
由于佐匹克隆片起效迅速,因此患者仅应在睡前立即服用或已经上床但难以入睡时服用。
应警告患者服用佐匹克隆片后不要从事需要保持精神高度警惕或运动协调性的危险职业(如操纵机器或开车),并警告他们服用佐匹克隆片后第二天从事这些活动可能会造成伤害。
佐匹克隆与其它催眠药一样,当与其它精神药物、抗惊厥药物、抗组胺药物、乙醇及其它本身可引起中枢神经系统抑制的药物同时服用时,可能会导致中枢神经系统抑制的相加效应。
服用佐匹克隆片时不能喝酒。
佐匹克隆片与其他中枢神经系统抑制剂同时服用时,由于有潜在的相加效应,可能需要调整其剂量。
一般注意事项本品含有乳糖,因此,本品禁忌应用在先天性半乳糖血症、葡萄糖或半乳糖吸收不良综合症或乳糖酶缺乏症患者。
耐受性:当在数周时间内应用苯二氮卓及其衍生药物时,尽管应用了相同的给药剂量,但是药物的镇静或催眠效应可能会逐渐下降。
在长达4周的本品给药期间,在接受治疗的患者中没有观察到任何显著的耐受性事件。
依赖性:任何的苯二氮卓及其衍生药物治疗均可以导致生理性和心理性药物依赖特别是长期治疗时。
多种因素似乎可以促进药物依赖性或滥用的出现,这些因素包括:- 治疗持续时间,- 给药剂量,- 具有对医药产品或其它物质(包括酒精)成瘾的病史,- 焦虑。
药物依赖性可以在治疗剂量下出现,和/或在没有特定危险因素的患者中出现。
在非常罕见的病例中,已经报道了在治疗剂量下出现佐匹克隆依赖性。
在停止治疗时,药物依赖性可以导致戒断症状的出现。
一些症状经常会出现,一般而言症状较轻,这些症状包括:失眠、头痛、明显的焦虑、肌痛、肌肉紧张和易怒。
其它症状较为罕见,这些症状包括:不安宁感,甚至出现意识混乱事件;肢体感觉异常;对光线、噪音过敏;对身体接触过敏;人格解体;现实感丧失;幻觉;惊厥。
在停止治疗后的数天内,可能会出现戒断症状。
当应用短效苯二氮卓类药物时,特别是在高剂量下进行给药时,戒断症状可能在两次连续给药之间的时间内出现。
多种苯二氮卓类药物的伴随应用可能会增加出现药物依赖的危险性,不管这些苯二氮卓类药物是用来抗焦虑,还是用来催眠。
也已经报道了一些药物滥用病例。
反跳性失眠症:在停止催眠药物治疗后,可能会出现短暂的反跳性失眠症,即需要镇静/催眠药物治疗的症状复发并增强。
作为失眠症的恶化,可能会出现短暂的反跳性失眠症,这促使患者应用苯二氮卓或其衍生药物进行治疗。
因为在佐匹克隆突然停药后出现此现象的风险升高,尤其是在长期治疗后,因此建议告知患者逐渐减量,并建议患者依从(参见【不良反应】)。
健忘症以及精神运动功能的变化:在应用该片剂后的数小时期间,可能会出现顺行性遗忘和精神运动功能的变化,尤其是在睡眠被打断或在口服本药后延迟上床休息。
为了降低这些危险性,患者应该在晚上睡觉之前的即刻服用该片剂(请参考【用法用量】),保证尽可能维持数小时的不间断睡眠状态。
行为紊乱:在一些患者中,苯二氮卓及其衍生药物如佐匹克隆可能会导致一种综合症的出现,该综合症表现为不同程度的意识变化、记忆和行为的紊乱症状:下列症状可能会出现:- 失眠症的恶化、恶梦、不安宁感、神经过敏,- 谵妄的思想、幻觉、梦样/混乱状态、精神病样症状,- 冲动行为抑制力的缺乏,- 精神欢快、易怒,- 顺行性遗忘,- 暗示感受性。
这些症状可能伴随有行为方面的紊乱,这可能对患者或他人产生危害,这些行为方面的紊乱包括:- 异常行为,- 自我攻击或者攻击他人,特别是在家庭成员或朋友企图阻止患者干他/她想干的事情时,- 伴有事后健忘症的无意识的行为。
如果出现这些症状,需要停止治疗。
这些反应更可能发生在老年人中。
梦游症和相关行为:在使用佐匹克隆并没有完全醒觉的患者,有睡眠行走和其它相关行为,如“睡眠驾车”、准备食物和进食食物或打电话,并遗忘事件的报告。
当服用超过最大推荐剂量佐匹克隆时,或佐匹克隆与酒精、其它CNS镇静药物同服时可增加上述行为的风险。
强烈建议发生上述行为的患者停止使用佐匹克隆(参见【相互作用】:酒精;以及参见【不良反应】:精神异常。
药物蓄积的危险性:苯二氮卓及其衍生药物(与任何药品一样)在人体内停留大约5个半衰期(请参考【药代动力学】)。