近日，美国食品和药物管理局（FDA）批准Sunosi（solriamfetol）上市，用于治疗成人患者与发作性睡病（narcolepsy）或阻塞性睡眠呼吸暂停（OSA）相关的白天过度嗜睡（EDS）。
Sunosi每日服药一次，批准用于发作性睡病患者的剂量为75mg和150mg，批准用于OSA患者的剂量为37.5mg、75mg、150mg。
Jazz董事长兼首席执行官Bruce Cozadd表示，“EDS会对发作性睡病或OSA患者的日常生活产生负面影响，无论是在工作、家庭还是日常活动中。此次批准，使患者可以获得一种新的日间药物，可以全天保持清醒。FDA对Sunosi的批准也代表着Jazz的一个重要里程碑，我们将继续提供新的治疗方案，以满足慢性睡眠障碍患者（通常是虚弱的睡眠障碍患者）的未满足需求。”
批准日期：2019年3月21日 公司:Jazz Pharmaceuticals
SUNOSI（solriamfetol）片剂，口服，CIV
美国最初批准：2019年
作用机制
solriamfetol改善嗜睡症或阻塞性睡眠呼吸暂停相关的白天过度嗜睡患者的觉醒的作用机制尚不清楚。然而，其功效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。
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）相关的白天过度嗜睡的成年患者的觉醒。
使用限制
SUNOSI不适用于治疗OSA中潜在的气道阻塞。确保在开始使用SUNOSI之前至少一个月治疗潜在的气道阻塞（例如持续气道正压（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：每日一次75mg。
•OSA患者的起始剂量：每日一次37.5mg。
•剂量可以至少3天的间隔增加。
•最大剂量为每天150毫克。
•肾功能不全：
•中度损伤：每日一次起始剂量为37.5mg。
o至少7天后，每天一次增加至75mg。
•严重损害：起始剂量和最大剂量为每日一次37.5mg。
•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严重心脏病的患者。
•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，可考虑减少剂量或停用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Jazz Pharmaceuticals，Inc。或致电1-800-FDA-1088或HTTP：//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
如何提供
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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f30ab12-20e1-4391-9359-24b23a21578d
U.S. FDA Approval of Sunosi™ (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
U.S. Food and Drug Administration (FDA) approved Sunosi™ (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Once-daily Sunosi is approved with doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and 150 mg for patients with OSA. Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to treat excessive daytime sleepiness in adults living with narcolepsy or OSA.
Sunosi is expected to be commercially available in the U.S. following the final scheduling decision by the U.S. Drug Enforcement Administration (DEA), which is typically within 90 days of FDA approval.
At Week 12, 150 mg of Sunosi for narcolepsy patients and all doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed in test sessions 1 (approximately one hour post-dose) through 5 (approximately nine hours post-dose) of the maintenance of wakefulness test (MWT).
About Sunosi™ (solriamfetol)
Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize Sunosi from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to Sunosi, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States.
Important Safety Information
SUNOSI 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 your SUNOSI to anyone else, because it may cause death or harm them. Selling or giving away SUNOSI may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Do not take SUNOSI if you are taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
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.
Pregnancy Registry: There is a pregnancy registry for women who take SUNOSI during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
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.
Especially tell your healthcare provider if you take a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
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.