您好,欢迎光临世界标品! 登录 注册(订药物标准品请用邮件联系我们)

中国医药研发对照标品提供商
Non-clinical Research-used
Medicine Sample Provider

当前本网站药物产品种数共 8473 处方药 8099 非处方药 268 保健品/医疗用具 106

世界标品医药目录搜索(中英文):
世界各国官方药品目录搜索(英文):
世界标品医药知识搜索(中英文):

联系方式
国内客服电话:
国际免费电话:


QQ客服1:1793093587
QQ客服2:1586083059
QQ客服3:2786706041
QQ客服6:2992753224
QQ客服7:2394834588

咨询邮箱:
scimed.shanghai@shijiebiaopin.com
info@shijiebiaopin.com
pharmacy.shijiebiaopin1@gmail.com
pharmacy.shijiebiaopin2@gmail.com

  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->催眠药物
处方药:处方药
包装规格: 3毫克/片 100片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
SOMAXON
生产厂家英文名:
SOMAXON
该药品相关信息网址1:
http://www.silenor.com/
该药品相关信息网址2:
http://www.rxlist.com/silenor-drug.htm
该药品相关信息网址3:
http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1090
原产地英文商品名:
SILENOR 3mg/tab 100tabs/box
原产地英文药品名:
DOXEPIN HCL
中文参考商品译名:
SILENOR 3毫克/片 100片/盒
中文参考药品译名:
盐酸多塞平
原产地国家批准上市年份:
2010/03/17
英文适应病症1:
Insomnia
临床试验期:
完成
中文适应病症参考翻译1:
失眠症
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201011323003920.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文Silenor处方资料(仅供参考)

    2010年3月18日,Somaxon制药公司(Somaxon Pharmaceuticals)宣布,美国食品药品管理局(FDA)已批准Silenor用于治疗以睡眠维持困难为特征的失眠症。Silenor是一种低剂量(3 mg、6 mg)多塞平片剂,现已获准用于治疗成人(包括老年人)暂时性和慢性失眠症。
  睡眠维持困难定义为夜间经常觉醒和(或)觉醒过早而无法再次入睡。据Somaxon公司称,该症状是最常报道的夜间失眠症状。临床试验证实,Silenor可使夜间睡眠达到7-8 h且次日无明显的后遗效应表现。
  FDA批准Silenor是依据相关的临床试验数据,这些临床试验共纳入受试者逾1,000例。临床试验表明,Silenor有着极优的安全性和耐受性。Silenor治疗组不良反应的总发生率与安慰剂对照组相当,患者无停药反应、耐受、遗忘或复杂的睡眠行为(如梦游驾驶症、梦游饮食症)等表现。
  鉴于Silenor经证实不具备滥用可能,美国缉毒局(US Drug Enforcement Administration)一直未将其列为受管制药品。另外,在Silenor的临床研发项目中,未观察到显示躯体依赖的停药反应或其他不良反应。
  Silenor与组胺受体具有较高的亲和力。研究认为,该药通过与组胺受体结合这一机制促进睡眠的维持。
  医护人员应知道,睡眠紊乱可能由潜在的躯体疾病和(或)精神失常所致,应在对患者进行仔细评估后,方开始失眠症对症治疗。治疗失眠7-10天后无效可能意味着存在原发性精神和(或)医学疾病,应对这类疾病进行评估。
  患者应仅在准备好获得整晚睡眠时服用Silenor,而且应在睡前30 min服用。应指导患者在服药期间戒除酒精饮料或停用其他可产生睡意的药物。另外,还应告诉患者避免从事危险作业,如夜间服用Silenor后骑摩托车等,而且应告诫患者白天服用Silenor后从事这类活动可能会带来危害。
  对存在未治疗的窄角型青光眼、重度尿潴留及重度睡眠呼吸暂停的患者不应开具Silenor处方。
  根据该药品的处方说明,Silenor的活性成分多塞平是催眠类药物的组成部分。多塞平用作抗抑郁药时的剂量较Silenor中的高10-100倍。有研究报道,原发性抑郁症患者抑郁加重(包括自杀意念和行为)与服用催眠药有关。由于服用催眠药的患者理论上存在精神病风险,故医生在开具Silenor处方前应询问患者有关精神病、自杀意念和抑郁等情况。

Drug Name: Silenor (doxepin)
Company: Somaxon Pharma
Approval Status: Approved March 2010
Treatment Area: insomnia

General Information
Silenor (doxepin) binds with high affinity to the histamine H1 receptor where it functions as an antagonist. The exact mechanism by which doxepin exerts its sleep maintenance effect is unknown but is believed due to its antagonism of the H1 receptor.

Silenor is specifically indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

Silenor is supplied as an immediate release tablet for oral administration. The recommended dose of Silenor for adults is 6 mg once daily. The recommended starting dose of Silenor in elderly patients (>65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if clinically indicated. Silenor should be taken within 30 minutes of bedtime.The total Silenor dose should not exceed 6 mg per day.

Clinical Results
FDA Approval
The efficacy of Silenor for improving sleep maintenance was supported by six randomized, double-blind studies in a total of 1,423 subjects, 18 to 93 years of age, with chronic or transient insomnia. Silenor was evaluated at doses of 1 mg, 3 mg, and 6 mg relative to placebo. The primary efficacy measures for assessment of sleep maintenance were the objective and subjective time spent awake after sleep onset (respectively, objective Wake After Sleep Onset [WASO] and subjective WASO).

Chronic Insomnia: Adults
A randomized, double-blind, parallel-group study was conducted in 221 adults with chronic insomnia. Silenor 3 mg and 6 mg was compared to placebo out to 30 days. Silenor 3 mg and 6 mg were superior to placebo on objective WASO. Silenor 3 mg was superior to placebo on subjective WASO at night 1 only. Silenor 6 mg was superior to placebo on subjective WASO at night 1, and nominally superior at some later time points out to Day 30.

Chronic Insomia: Elderly
Elderly subjects with chronic insomnia were assessed in two parallel-group studies. The first randomized, double-blind study assessed Silenor 1 mg and 3 mg relative to placebo for 3 months in inpatient and outpatient settings in elderly subjects (N=240) with chronic insomnia. Silenor 3 mg was superior to placebo on objective WASO. The second randomized, double-blind study assessed Silenor 6 mg relative to placebo for 4 weeks in an outpatient setting in elderly subjects (N=254) with chronic insomnia. On subjective WASO, Silenor 6 mg was superior to placebo.

Transient Insomnia
A randomized, double-blind, parallel-group, single-dose study enrolled 565 healthy adults who were experiencing transient insomnia during the first night in a sleep laboratory. Silenor 6 mg was superior to placebo on objective WASO and subjective WASO.

Withdrawal Effects
Potential withdrawal effects were assessed in a 35-day double blind study of adults with chronic insomnia who were randomized to placebo, Silenor 3 mg, or Silenor 6 mg. There was no indication of a withdrawal syndrome after discontinuation of Silenor treatment (3 mg or 6 mg), as measured by the Tyrer’s Symptom Checklist. Discontinuation-period emergent nausea and vomiting occurred in 5% of subjects treated with 6 mg Silenor, versus 0% in 3 mg and placebo subjects.

Rebound Insomnia Effects
Rebound insomnia, defined as a worsening in WASO compared with baseline following discontinuation of treatment, was assessed in a double-blind, 35-day study in adults with chronic insomnia. Silenor 3 mg and 6 mg showed no evidence of rebound insomnia.

Side Effects
Adverse events associated with the use of Silenor may include, but are not limited to, the following:
somnolence
sedation
nausea
upper respiratory tract infection

Mechanism of Action
Silenor (doxepin) binds with high affinity to the histamine H1 receptor where it functions as an antagonist. The exact mechanism by which doxepin exerts its sleep maintenance effect is unknown but is believed due to its antagonism of the H1 receptor.

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201011323003920.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2013-4-22
附件:






201011323003920.pdf    

 
调控比例: 100%
订购表单下载
Copyrights © 2010,2011,2012 www.ShiJieBiaoPin.com, Inc., All rights Reserved www.ShiJieBiaoPin.com, Inc.
客服工作时间:太平洋时间18:00-24:00
国内客服电话:     国际免费电话:
友情提示:以上电话为免费电话,无需您承担任何费用,世界标品提供中文客服,请您放心拨打!
电子邮箱:info.shijiebiaopin.com@gmail.com, info@shijiebiaopin.com