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当前位置:药品说明书与价格首页 >> 精神心理 >> 药品目录 >> 改善睡眠及安神药类 >> 拉米替隆片剂(Rozerem Ramelteon)

拉米替隆片剂(Rozerem Ramelteon)

2011-01-16 11:19:27  作者:新特药房  来源:中国新特药网天津分站  浏览次数:799  文字大小:【】【】【
简介: 英文名:Ramelteon 商品名:Rozerem化学名: (S)-N-[2-(1,6,7,8-四氢-2H-茚-[5,4-b]呋喃-8-取代)]丙酰胺化学结构式:分子式:C16H21NO2 分子量:259.35适应症:用于治疗难以入睡型失眠症 剂型规格:8mg ...

英文名:Ramelteon
商品名:Rozerem
化学名: (S)-N-[2-(1,6,7,8-四氢-2H-茚-[5,4-b]呋喃-8-取代)]丙酰胺
化学结构式:
分子式:C16H21NO2
分子量:259.35
【适应症】:用于治疗难以入睡型失眠症
【剂型规格】:8mg片剂


Rozerem由日本武田制药公司开发,2005年7月22日获FDA批准上市,是该公司首个在美国独立上市的产品,估计亦会于近期在日本申请上市。FDA的批准表明医生可将Rozerem作为成人失眠症患者的长期治疗药物。Rozerem是第一种也是唯一一种不会导致患者滥用药和产生药物依赖性的处方类安眠药,因此它未被美国药品管制局(DEA)列为控制类药品。除了Rozerem外,其他的处方类安眠药都被DEA列为IV类控制产品。此外,Rozerem也是35年来第一种具有新型药理作用的处方类安眠药.
【药理及临床研究】
目前常用安眠药的作用机理一般都是大范围抑制人体脑部神经活动。而Rozerem具有独特的药理,即选择性地作用于人体下丘脑视交叉上核(SCN)中的两个受体。SCN就是为人们所知的“生物钟”,它调节人体24小时的周期性生物节律,其中就包括入眠-清醒这一周期。研究结果显示,使用该药后不会出现过度使用、停药反应、药物依赖性和“宿醉”( 第二日的后遗作用)等不良反应。
【临床三期研究结果显示】Ramelteon能有效缩短患者入睡的时间,增加总的睡眠时间,提高睡眠效率,且对次日工作、学习的负面影响较小,停药后的复发率也很低。在1项研究中,472例患者一日1次服用本品长达1年。根据新近的临床研究结果显示,本品对老年患者、轻中度某些阻塞性肺部疾病(COPD)患者和轻中度睡眠性呼吸暂停患者用药安全。
【药物特点】
Ramelteon与目前常用的GABAA受体作用药物相比,除同样具有吸收迅速,可以快速引导睡眠,具有适宜的药物半衰期等优点外,还具有以下独特优势,是一种接近理想化的失眠治疗药物。
1. 可诱导生理性睡眠
2. 不影响记忆
3. 无耐药性,不会出现过度使用等问题
4. 无药物依赖性
5. 不会引起过度镇静
6. 不会引起反跳性失眠、停药反应等
7. 与酒精(乙醇)不会产生相互作用

【不良反应】 当拉米替隆每天口服8mg,一天一次时,患者通常耐受性良好。在安全性临床试验(n52620)中,拉米替隆治疗组最常见的不良事件类型和发生率与安慰剂对照相似。拉米替隆有可能导致肾上腺皮质机能减退。

【剂量及用药】 拉米替隆为一种口服片剂,规格为每片8mg。拉米替隆在成人和老年人中的推荐剂量为每天睡前一片(8mg)。拉米替隆在青少年或儿童中的安全性和有效性数据尚不十分清楚。严重肝功能损害患者最好避免服用拉米替隆,中度肝病患者也应慎用。

【用药提示】 患者最好在就寝前30分钟内服用拉米替隆,这样可以避免患者服药后从事危险活动(如操作机械等)。患者应避免在高脂饮食的同时或之后立即服用拉米替隆。

Rozerem (Ramelteon)

Rozerem is one of several sleep aid products that claims to provide a restful, easy night's sleep, leaving users wide awake and ready to start the day in the morning. However, those who have long suffered from occasional insomnia and sleep disturbances are well aware that when it comes to sleep aid products, careful evaluation of all aspects of the product, especially the ingredients, is necessary before investing time and money in the treatment.

Rozerem is at a disadvantage among sleep aid products due to the fact that acquiring Rozerem requires a prescription, but further investigation indicates that when compared to other sleep aids, especially natural and herbal solutions, Rozerem has more going against it then initially meets the eye.

Rozerem Ingredients

Rozerem ReviewThe active ingredient in Rozerem is ramelteon. Rozerem does not contain any of the ingredients found in quality, natural, herbal sleep aid products such as melatonin or 5HTP, both of which have been shown to work with the body's natural chemistry to encourage natural sleep that conforms to the rhythms of the body. Instead, Rozerem relies on ramelteon, which mimics the effects of melatonin.

Those interested in Rozerem should wonder why it would use an ingredient designed to imitate melatonin, when melatonin is much less expensive, more widely available, and has been proven to be safe for use in humans. Conversely, the active ingredient in Rozerem has been shown to cause an increase in cancer in lab mice, and the long term safety of the product in use in humans has yet to be shown.

Rozerem Side Effects

The side effects of Rozerem are startling. Like many prescription and over the counter sleep aids that do not include natural ingredients designed to work with the body's natural chemistry, many users of Rozerem can expect headaches, dry mouth, upset stomachs, weakness and blurred vision as common side effects. However, what is especially surprising about Rozerem is that many users of the medication have reported a worsening of insomnia and sleeplessness.

For those who have been suffering from insomnia and sleep disturbances for an extended period of time, it is an extreme shock and disappointment to take Rozerem and find themselves worse off than they were before ever encountering the product. Additionally, some users of Rozerem have experienced dramatic changes in mood, depression and negative sexual side effects as well, such as decreased sex drive and even missed monthly periods in women.

Buy Rozerem

When you are considering the cost of Rozerem, there is more than the financial cost at play. First of all, Rozerem is a prescription medication, requiring a visit to the doctor. For those without medical insurance, this may immediately make Rozerem too expensive to consider. Additionally, even for those with quality medical insurance, Rozerem will require one or more visits to the doctor, with all applicable co-pays, plus the inconvenience of taking time off of work and traveling to the doctor's office. On top of the doctor's visit, those interested in Rozerem will have to consult with their medical insurance provider to see if the medication is covered by their plan. For those without prescription coverage or if Rozerem is not covered for one reason or another, purchasing Rozerem will require a hefty out of pocket expense.

Unlike over the counter products or natural herbal products available over the internet, the cost of Rozerem can be steep. Prescriptions rarely offer discounts for purchasing several months at a time, unlike herbal products, though occasionally a free seven night trial of Rozerem can be acquired.

Does Rozerem work?

When it comes to Rozerem, it almost seems impossible to evaluate the effectiveness of the product due to the numerous and severe side effects that often appear with use of the product. Those struggling with sleep issues and insomnia are often desperate to find a solution to help to improve the overall quality of their life along with the quality of their sleep.

When taking Rozerem, the fact that many people suffer from mental, sexual and other physical side effects often outweigh the effectiveness of the product in terms of sleep quality. Additionally, the fact that Rozerem can even cause a worsening of insomnia and sleep disturbances makes Rozerem an extremely unattractive option for those who have seriously researched the available products to help with their own sleep disturbances.

责任编辑:admin


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