近日，美国食品和药物管理局（FDA）批准Sunosi（solriamfetol）改善成人患者的觉醒，这些患者白天嗜睡与嗜睡症或阻塞性睡眠呼吸暂停相关（OSA））。 每日一次的Sunosi被批准用于嗜睡症患者的剂量为75mg和150mg，对OSA患者的剂量为37.5mg，75mg和150mg。Sunosi是第一种双重作用的多巴胺和去甲肾上腺素再摄取抑制剂（DNRI），用于治疗患有发作性睡病或OSA的成年人过度白天嗜睡。
批准日期：2019年3月20日 公司：爵士制药
SUNOSI（solriamfetol）片，用于口服，[受控物质安排待定]
美国最初批准：[待定受控物质调度]
作用机制
solriamfetol用于改善与发作性睡病或阻塞性睡眠呼吸暂停相关的过度嗜睡患者的觉醒的作用机制可以通过其作为多巴胺和去甲肾上腺素再摄取抑制剂（DNRI）的活性来介导。不清楚。
适应症和用法
SUNOSI是一种多巴胺和去甲肾上腺素再摄取抑制剂（DNRI），用于改善与嗜睡症或阻塞性睡眠呼吸暂停（OSA）相关的过度白天睡眠的成年患者的觉醒。
使用限制
SUNOSI不适用于治疗OSA中潜在的气道阻塞。
确保在开始SOSOSI之前至少一个月治疗潜在的气道阻塞（例如，持续气道压力（CPAP）），以避免白天过度嗜睡。在使用SUNOSI治疗期间，应继续治疗潜在的气道阻塞的方式。
SUNOSI不能替代这些方式。
剂量和给药
唤醒后每天管理一次。避免在计划就寝时间的9小时内给药，因为可能会干扰睡眠。
发作性睡病患者的起始剂量：每天一次75毫克。
OSA患者的起始剂量：每日37.5 mg。
剂量可以至少3天的间隔增加。
最大剂量为每天一次150毫克。
肾功能不全：
中度损伤：起始剂量为每日一次37.5毫克。
至少7天后，每日一次可增加至75毫克。
严重损伤：起始剂量和最大剂量为每天37.5mgonce。
终末期肾病（ESRD）：不推荐。
剂量形式和强度
片剂：75mg（功能评分）和150mg。
禁忌症
在前14天内用单胺氧化酶抑制剂（MAOI）同时治疗或使用MAOI。
警告和注意事项
血压和心率增加：在开始前和治疗期间定期测量心率和血压。
治疗前和治疗期间控制高血压。避免用于患有不稳定心血管疾病，严重心律失常或其他心脏病的患者。
精神症状：在治疗有精神病或双相情感障碍病史的患者时要小心。如果出现精神症状，可考虑减少或停用SUNOSI。
不良反应
最常见的不良反应（≥5％，大于安慰剂）：头痛，恶心，食欲减退，失眠和焦虑。
要报告疑似不良反应，请致电1-800-520-5568联系JazzPharmaceuticals，Inc。或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
增加血压和/或心率和多巴胺能药物的药物：与SUNOSI共同给药时要小心。
包装提供/存储和处理
提供
SUNOSI采用30支装和100支白色高密度聚乙烯（HDPE）瓶包装。
SUNOSI片剂，75毫克-深黄色长方形片剂，一侧有“75”凹陷，另一侧有功能性评分线。
NDC 68727-350-01：30瓶装儿童防护罩
NDC 68727-350-02：100瓶装儿童防护罩
SUNOSI片剂，150毫克-黄色长方形片剂，一面有“150”凹陷。
NDC 68727-351-01：30瓶装儿童防护罩
NDC 68727-351-02：100瓶装儿童防护罩
存储
将SUNOSI储存在20°至25°C（68°至77°F）; 允许的偏差在15°至30°C（59°至86°F）之间（参见USP控制的室温）。
完整说明资料附件：https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Sunosi is approved by the FDA to improve wakefulness in adult patients with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). However, it will not be available until it is scheduled as a controlled substance.
IMPORTANT SAFETY INFORMATION
SUNOSI (solriamfetol) 75mg and 150 mg tablets is a federally controlled substance (C-XX) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:
have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
have had a heart attack or a stroke
have kidney problems or diabetes
have a history of mental health problems(including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
What are the possible side effects of SUNOSI?
SUNOSI may cause serious side effects, including:
Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before you start and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop anxiety, problems sleeping, irritability, agitation. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:
headache
nausea
decreased appetite
anxiety
problems sleeping
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.