武田制药北美分公司近日宣布，FDA已经批准其安眠药ROZEREM(ramelteon) 的8毫克片剂。这项批准表明医生可将ROZEREM用于成人失眠症的长期治疗。

   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ROZEREM外，其他的处方类安眠药都被DEA列为表IV中的控制类产品。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，患者将能在9月份用上此药。

   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。因此使用该药后不会出现过量、停药反应、药物依赖性和第二天的残留作用。

Rozerem
Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the DEA. With the exception of Rozerem, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years.
What Is Rozerem?

Rozerem is a prescription medicine for adults to treat insomnia where the problem is trouble falling asleep.

Rozerem has not been studied in children.  It is not known if Rozerem is safe and effective for children.

Who Should Not Take Rozerem?

You should not take Rozerem if you have any of the following conditions:

are allergic to ramelteon or any of its ingredients

have severe liver disease

What Are The Risks?

The following are the major potential risks and side effects of Rozerem therapy. However, this list is not complete. The following are the major potential risks and side effects of Rozerem therapy:

Worsening of insomnia, mental, or behavior changes. These may happen if your insomnia is caused by a mental or medical problem. Your healthcare professional should check you carefully for other health problems before prescribing Rozerem. Tell your healthcare professional if you develop:
worse insomnia

mental problems including thoughts of harming yourself

behavior changes

Drowsiness.  Rozerem may affect your ability to drive or do other dangerous activities. Do not do these activities after taking Rozerem.  After taking Rozerem, do only activities needed to get ready for bed. 
Affect reproductive hormones.  Rozerem may affect the reproductive hormones by increasing prolactin and potentially decreasing testosterone levels. This may cause missed monthly periods, nipple drainage, decreased sex drive, or problems getting pregnant.  Your healthcare professional may do blood tests to check your hormone levels if you have any of these symptoms. 
 Some common side effects that may occur with Rozerem include:
headache

daytime sleepiness

dizziness

tiredness

nausea

worsening insomnia

colds

What Should I Tell My Healthcare Professional Before Taking Rozerem?

Before you start taking Rozerem, tell your doctor if you: 

have or had liver disease

have breathing problems when you sleep (severe sleep apnea) or a lung disease called severe chronic obstructive pulmonary disease (COPD).  Rozerem is not recommended if you have these problems.

are trying to become pregnant, already pregnant, or are breastfeeding

a history of depression, mental illness, or suicidal thoughts; or

a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use Rozerem, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not know whether Rozerem passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Rozerem may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility in either men or women.

The sedative effects of Rozerem may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking Rozerem.

Rozerem may be habit-forming and should be used only by the person it was prescribed for. Rozerem should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep Rozerem in a secure place where others cannot get to it.

Can Other Medicines or Food Affect Rozerem?

Rozerem and certain other medicines can interact with each other.  Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Some medicines may affect how Rozerem works or Rozerem may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Especially, tell your healthcare professional if you take:

fluvoxamine
rifampin (Rifadin)
ketoconazole (Nizoral)
fluconazole (Diflucan)
tramadol COD
Tell your healthcare provider if you drink alcohol.  Alcohol may increase the side effects with Rozerem.

How Should I Take Rozerem?

Take Rozerem by mouth within 30 minutes of going to bed.

Do not take Rozerem with or right after a high fat meal.

睡眠：Rozerem（ramelteon）发现安全有效的瞬态失眠

Rozerem（ramelteon），褪黑激素受体激动剂一个一年前批准作为治疗失眠的不定期剂，既安全又被发现在一个短暂的失眠实验室模型有效，纽约研究人员在这里说。

行动要点

* 有兴趣的病人解释，这项研究表明，Rozerem（ramelteon），用于治疗失眠批准，可以不采取应对残余影响，偶尔入睡困难。

* 这项研究已作为一个抽象的，在一次会议上口头提出。这些数据和结论应被视为是初步的，因为他们尚未审查并在同行评审的出版物出版。

该药物花费的时间减少了与会者入睡，睡眠质量提高了，精神运动，没有剩余或记忆效应的第二天，加里说Zammit，博士，圣Luke's，在纽约罗斯福医院。

这一发现是有价值的，因为它给了医生和病人的药物，可以在事先未安排的基础上采取以应付偶尔失眠，博士Zammit报告中发表于SLEEP 2006年，睡眠研究会与美国科学院联合会议睡眠医学。

Zammit博士及其同事参加了一项随机，安慰剂对照平行分组两种不同剂量的Rozerem，8毫克和16毫克的研究289健康的成年人。这项研究由武田林肯郡，伊利诺伊州的Rozerem，一褪黑激素受体激动剂结合到大脑中的受体MT1和MT2开发药品。

参与者被转化为一个晚上的睡眠实验室带来博士Zammit在采访中说。 “当我们进入睡眠实验室带来一晚的人，他们有什么叫做”第一晚效应，他们需要更长的时间才能入睡，他们的睡眠被打乱，“他说。

这种情况是一种“理想模式”的短暂失眠，对偶尔无法入睡熟悉的情况，博士Zammit说。

研究发现：

* 那些服用8毫克的Rozerem上睡着了，平均在12.2分钟，比服用安慰剂的患者为19.7，此差异有统计学上显着 P=0.004.
* 那些服用16毫克也睡着了较快的14.8分钟，平均，但差异不显着，与安慰剂相比。
* 总睡眠时间也有所增加。服用安慰剂的患者睡四百一十九点七分钟，平均比四百三十六点八分钟为8毫克的剂量和433.1为16毫克剂量分钟。从安慰剂的差异显着的 P= 0.009和 P= 0.043，分别为。

对低剂量提高疗效意味着博士Zammit说，“有没有出现是剂量反应关系。”

第二天早上停留在实验室，研究人员检查立即和延迟回忆参与者使用标准的数字符号替换测试，内存测试和视觉模拟量表来衡量的情绪和感觉。 “有没有第二天减值，证据”安慰剂相比，博士Zammit说。

不良反应在研究所有三个武器罕见，大致相同，研究人员发现。事件率分别为12.4％，13.3％和6.4％的安慰剂，8毫克，16毫克组，分别为。在任何实验室有值，生命体征，或心电图结果无临床意义的变化。

最常见的副作用是嗜睡，服用安慰剂的患者由两个和三个两个积极治疗每一条手臂报告。

“这是一个重要的治疗，”博士Zammit说，“因为它是一个计划外的治疗，它提供了一个没有镇静或第二天的残余影响睡眠产生影响。”

该模型Zammit博士和同事使用是相当良好的方法建立在对睡眠研究的急性应激的影响，迈克尔说Sateia，达特茅斯医学院的医学博士，在黎巴嫩，新罕布什尔州

但他呼吁扩大成果的人谁偶尔有一个不眠之夜谨慎，想一丸，以帮助他们。

“如果有一个暗示，这个或任何其他类型的安眠药应该是一个非常固定的时间限制的压力引起的暂时性失眠，”博士Sateia在采访中说，“我认为（医生），大部分会是非常不舒服。“

他说：“这些都是自发的​​，通常不解决和可能不应该，需要药物干预。”
另一方面，博士Sateia说，有可能是在人们与较长期的压力引起的失眠药物，威胁要发展成为更顽固性失眠的地方。