制造商：
Somaxon制药
药理分类：
H1受体拮抗剂。
活性成分（补）：
多塞平（如盐酸）3毫克，6毫克;标签。
指示（补）：
治疗失眠的特点是与睡眠维持困难。
药理作用：
多塞平结合高亲和力的组胺H1受体拮抗剂的地方作为它的职能。多塞平睡眠维持的效果，相信是由于H1受体拮抗活性的抑制中枢神经系统。
临床试验：
该Silenor在改善睡眠维持疗效评价六个随机，涉及有长期失眠，或短暂失眠三个月的历史1423例成人双盲临床试验。这些研究持续时间长达三个月。睡眠维持疗效的措施主要是客观和主观时间花在睡眠后发病（入睡后[WASO]客观和主观WASO唤醒）清醒。
第一项研究，为期30天的安慰剂对照试验，涉及221例慢性失眠表明，Silenor为3mg和6mg均优于安慰剂客观WASO，成人患者。 Silenor为3mg优于安慰剂主观WASO晚上1只。 Silenor 6毫克优于安慰剂主观WASO晚上1，并在以后的某个时间点的名义出优于第30天。两项随机，双盲三个月和四个星期的时间研究，分别进行了共494例慢性失眠老年患者。分别的数据显示Silenor 3毫克的研究要优于客观WASO和Silenor 6毫克安慰剂要优于主观WASO安慰剂。采用随机，单剂量研究中565名成年人进行短暂失眠，在睡眠实验室中显示Silenor 6毫克的第一个晚上要优于基于客观和主观WASO安慰剂。
法律分类：
接收
成人：
个别化。睡前30分钟内采取。不要把吃饭后3小时。最初6毫克，每日一次。马克斯：6mg/day。老年人，肝功能不全，尿潴留倾向：最初3毫克，每日一次。
儿童：
不推荐。
禁忌（补）：
过程中或在14天的单胺氧化抑制剂。未经治疗的窄角型青光眼。严重尿潴留。
警告/注意事项：
评估共病诊断（例如，身体或精神障碍）治疗前。重新评估后，如果失眠持续7-10天的使用。监控开始了新的行为改变，抑郁症的恶化，或自杀的想法。肝功能不全。呼吸功能障碍。严重的睡眠呼吸暂停：不推荐。代谢不佳（与减少CYP2D6/2C19活动除外）。定期重新评估。老人。妊娠（Cat.C）。哺乳的母亲。
互动（补）：
伴中枢神经系统的镇静剂，抗组织胺，或酒精（避免）加性效应，降低剂量。 Potentiated的西咪替丁。低血糖可能与tolazamide。
不良反应（补）：
嗜睡，镇静，恶心，上呼吸道感染，头晕，光敏，皮疹，超常思维，行为变化，复杂的行为，睡眠驾驶（停止如果发生），健忘，焦虑等神经精神症状。
如何提供：
制表- 30，100，500
最后更新：
2010年9月24日
SILENOR
Manufacturer:
Somaxon Pharmaceuticals
Pharmacological Class:
H1 receptor antagonist.
Active Ingredient(s):
Doxepin (as HCl) 3mg, 6mg; tabs.
Indication(s):
Treatment of insomnia characterized by difficulty with sleep maintenance.
Pharmacology:
Doxepin binds with high affinity to the histamine H1 receptor where it functions as an antagonist. The sleep maintenance effects of doxepin are believed to be due to the antagonism of the H1 receptor which depresses CNS activity.
Clinical Trials:
The efficacy of Silenor in the improvement of sleep maintenance was evaluated in six randomized, double-blind clinical trials involving 1,423 adult patients with a three-month history of chronic insomnia, or transient insomnia. Duration of the studies was up to three months. Primary efficacy measures of sleep maintenance were the objective and subjective time spent awake after sleep onset (objective Wake After Sleep Onset [WASO] and subjective WASO).
The first study, a 30-day placebo-controlled trial involving 221 adult patients with chronic insomnia, demonstrated that Silenor 3mg and 6mg were superior to placebo on objective WASO. Silenor 3mg was superior to placebo on subjective WASO at night 1 only. Silenor 6mg was superior to placebo on subjective WASO at night 1, and nominally superior at some later time points out to Day 30. Two randomized, double-blind studies of three months and four weeks duration, respectively, were conducted in 494 total elderly patients with chronic insomnia. Data from the studies respectively demonstrated Silenor 3mg to be superior to placebo on objective WASO and Silenor 6mg to be superior to placebo on subjective WASO. A randomized, single-dose study conducted in 565 adults with transient insomnia during the first night in a sleep laboratory showed Silenor 6mg to be superior to placebo on objective and subjective WASO.
Legal Classification:
Rx
Adults:
Individualize. Take within 30mins of bedtime. Do not take within 3 hours of a meal. Initially 6mg once daily. Max: 6mg/day. Elderly, hepatic impairment, tendency to urinary retention: initially 3mg once daily.
Children:
Not recommended.
Contraindication(s):
During or within 14 days of MAOIs. Untreated narrow angle glaucoma. Severe urinary retention.
Warnings/Precautions:
Evaluate for co-morbid diagnoses (eg, physical or psychiatric disorders) prior to treatment. Reevaluate if insomnia persists after 7–10 days of use. Monitor for new onset behavioral changes, worsening of depression, or suicidal thinking. Hepatic impairment. Respiratory dysfunction. Severe sleep apnea: not recommended. Poor metabolizers (those with reduced CYP2D6/2C19 activity). Reevaluate periodically. Elderly. Pregnancy (Cat.C). Nursing mothers.
Interaction(s):
Additive effects with concomitant CNS depressants, antihistamines, or alcohol (avoid); reduce dose. Potentiated by cimetidine. Possible hypoglycemia with tolazamide.
Adverse Reaction(s):
Somnolence, sedation, nausea, upper respiratory tract infection, dizziness, photosensitivity, skin rash; abnormal thinking, behavioral changes, complex behaviors, sleep-driving (discontinue if occurs), amnesia, anxiety, other neuropsychiatric symptoms.
How Supplied:
Tabs—30, 100, 500