制造商：
头部公司
药理分类：
觉醒启动
活性成分（补）：
Armodafinil 50毫克，150毫克，250毫克;标签。
指示（补）：
为了改善与阻塞性睡眠呼吸暂停/低通气综合征（OSAHS），嗜睡症和轮班工作睡眠障碍（SWSD）相关过度嗜睡病人清醒。在辅助气道阻塞的OSAHS的根本标准治疗。
药理作用：
Armodafinil是R -莫达非尼（服用Provigil）对映体。在这两种对映体组成莫达非尼中，R -形式更持久。这些药物都具有觉醒，类似的促进作用，如安非他明的和利他的一例。
临床试验：
两个12周的研究是建立在OSAHS患者的安全性和armodafinil疗效。在第一项研究中，给予病患要么armodafinil为150mg或250mg/day，或安慰剂。第二个试验比较了armodafinil 150mg/day和安慰剂的效果。这两项研究表明，由于armodafinil患者表现出的能力都保持清醒，并在其整体临床状况的改善。
一个12周的研究结果表明，armodafinil进行的是在改善与相关过度嗜睡与昏睡症患者失眠有效。患者治疗armodafinil为150mg或250mg/day呈显着增强能力保持清醒，给予armodafinil病患更加全面提高了一比服用安慰剂的临床状况。
为期12周的试验是建立在慢性SWSD患者的armodafinil疗效。患者随机接受armodafinil 150mg/day或安慰剂。者给予药物的研究显示，入睡时间，睡眠潜伏期，如通过在一段时间内最后一次访问夜班进行模拟试验测一个显着延长，而那些服用安慰剂。此外，随着armodafinil治疗更多的患者总的临床经验，在条件的改善，而服用安慰剂的患者给予。
法律分类：
哀
成人：
≥17yrs：OSAHS患者，猝睡症：150毫克或250毫克一次在每天上午。 SWSD：150毫克前一小时开始转变。重度肝损害：减少剂量。
儿童：
<17yrs：不推荐。
警告/注意事项：
如果出现皮疹停止（除非显然不是毒品有关的），或者如果血管性水肿，过敏症，或者多器官过敏反应发生。 OSAHS患者：治疗基本阻塞，保持呼吸机使用，如果表示。左心室肥大或二尖瓣脱垂综合征（例如，缺血性心电图改变，胸痛，心律失常相关的中枢神经系统兴奋剂）历史：不推荐。最近的心肌梗塞。不稳定型心绞痛。监测血压。精神病。抑郁症。躁狂症。严重肝或肾功能损害。定期重新评估。老人（可能需要减少剂量）。劳动和交付。妊娠（Cat.C）。哺乳的母亲。
互动（补）：
可拮抗激素避孕药具;期间和1个月后使用替代或额外的避孕措施。避免饮酒。注意与单胺氧化抑制剂。 Armodafinil水平可能下降了CYP3A4的诱导剂（如卡马西平，苯巴比妥，利福平）和CYP3A4抑制剂（如酮康唑，红霉素）增加。可减少被CYP3A4（如环孢菌素）代谢的药物水平。经CYP2C9的药物可能会增加代谢水平（如华法林）或CYP2C19基因（如苯妥英，地西泮，普萘洛尔）。
不良反应（补）：
头痛，失眠，影响其他中枢神经系统，胃肠不适，皮疹（可能是严重的，例如，史蒂文斯-约翰逊，中毒性表皮坏死松解症）。
如何提供：
制表- 60
最后更新：
二○○九年六月十八日 
Manufacturer:
Cephalon, Inc.
Pharmacological Class:
Wakefulness promoter
Active Ingredient(s):
Armodafinil 50mg, 150mg, 250mg; tabs.
Indication(s):
To improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD). Adjunct to standard treatment for underlying airway obstruction in OSAHS.
Pharmacology:
Armodafinil is the R-enantiomer of modafinil (Provigil). Of the two enantiomers that comprise modafinil, the R-form is longer lasting. Both of these drugs have wakefulness-promoting effects similar to those of sympathomimetics such as amphetamines and methylphenidate.
Clinical Trials:
Two 12-week studies were conducted to establish the safety and efficacy of armodafinil in OSAHS. In the first study, patients were given to either armodafinil 150mg or 250mg/day, or placebo. The second trial compared the effects of armodafinil 150mg/day and placebo. Both studies indicated that patients given armodafinil showed improvements in both their ability to remain awake and in their overall clinical condition.
The results of a 12-week study conducted indicated that armodafinil was effective in improving wakefulness in patients with excessive sleepiness associated with narcolepsy. Patients treated with armodafinil 150mg or 250mg/day showed a significantly enhanced ability to remain awake, and more of the patients given armodafinil had an improved overall clinical condition than those given placebo.
A 12-week trial was conducted to establish the efficacy of armodafinil in patients with chronic SWSD. Patients were randomized to receive either armodafinil 150mg/day or placebo. Those given the study drug showed a significant prolongation in the time to sleep onset, as measured by a sleep latency test conducted during a simulated night shift at the final visit, compared to those given placebo. Also, more patients treated with armodafinil experienced an improvement in overall clinical condition, compared to patients given the placebo.
Legal Classification:
CIV
Adults:
≥17yrs: OSAHS, narcolepsy: 150mg or 250mg once daily in the AM. SWSD: 150mg one hour before starting shift. Severe hepatic impairment: reduce dose.
Children:
<17yrs: not recommended.
Warnings/Precautions:
Discontinue if rash appears (unless clearly not drug-related), or if angioedema, anaphylaxis, or multi-organ hypersensitivity reaction occurs. OSAHS: treat underlying obstruction; maintain CPAP use if indicated. History of LV hypertrophy or mitral valve prolapse syndrome (eg, ischemic ECG changes, chest pain, arrhythmias associated with CNS stimulants): not recommended. Recent MI. Unstable angina. Monitor BP. Psychosis. Depression. Mania. Severe hepatic or renal impairment. Reevaluate periodically. Elderly (may need to reduce dose). Labor & delivery. Pregnancy (Cat.C). Nursing mothers.
Interaction(s):
May antagonize hormonal contraceptives; use alternative or additional contraception during and for 1 month after. Avoid alcohol. Caution with MAOIs. Armodafinil levels may be decreased by CYP3A4 inducers (eg, carbamazepine, phenobarbital, rifampin) and increased by CYP3A4 inhibitors (eg, ketoconazole, erythromycin). May reduce levels of drugs metabolized by CYP3A4 (eg, cyclosporine). May increase levels of drugs metabolized by CYP2C9 (eg, warfarin) or CYP2C19 (eg, phenytoin, diazepam, propranolol).
Adverse Reaction(s):
Headache, insomnia, other CNS effects, GI upset; rash (may be serious, eg, Stevens-Johnson, toxic epidermal necrolysis).
How Supplied:
Tabs—60