Sleep Medicine and Research Center, St. Luke's Hospital, Chesterfield, Missouri.
Case Western Reserve University, Cleveland, Ohio.
J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.
Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved in the United States and European Union to treat excessive daytime sleepiness in patients with obstructive sleep apnea (OSA) (37.5-150 mg/day) and narcolepsy (75-150 mg/day). This analysis evaluated solriamfetol's efficacy in subgroups of participants with OSA who were adherent or nonadherent to primary OSA therapy at baseline and examined whether solriamfetol affected the use of primary therapy in an open-label extension trial.
Participants with OSA who completed prior solriamfetol studies received solriamfetol 75, 150, or 300 mg/day for ≤ 52 weeks. The main efficacy outcome was the Epworth Sleepiness Scale score. Primary therapy use was summarized as the percentage of nights, the number of hours/night, and the percentage of nights with use ≥ 50%/night (%). Efficacy and primary therapy use are reported for participants who directly enrolled from a previous 12-week study and had ≤ 40 weeks of open-label treatment (n = 333). Safety data are reported for all participants (n = 417).
Mean ESS scores in adherent (n = 255) and nonadherent (n = 78) subgroups, respectively, were 15.0 and 15.8 at baseline (of 12-week study) and 6.5 and 6.8 at week 40. For participants using an airway therapy, mean use at baseline was 90% of nights, 6.6 hours/night, and use ≥ 50%/night on 90% of nights; changes from baseline to week 40 were minimal (0.9%, -0.8 hours, and 6.5%, respectively). Common adverse events (both subgroups) included headache, nasopharyngitis, insomnia, dry mouth, nausea, anxiety, and upper respiratory tract infection.
Long-term efficacy and safety of solriamfetol were similar regardless of adherence to primary OSA therapy. Solriamfetol did not affect primary therapy use.
Registry: ClinicalTrials.gov; Name: A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or OSA; URL: https://clinicaltrials.gov/ct2/show/NCT02348632; Identifier: NCT02348632 and Registry: EU Clinical Trials Register; Identifier: 2014-005489-31; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-005489-31..
索里昂福莫特罗是一种多巴胺/去甲肾上腺素再摄取抑制剂，已获美国和欧盟批准，用于治疗阻塞性睡眠呼吸暂停（OSA）患者（37.5-150mg/天）和发作性睡病患者（75-150mg/天）的日间过度嗜睡。本分析评估了索里昂福莫特罗在基线时坚持或不坚持主要 OSA 治疗的 OSA 参与者亚组中的疗效，并检查了索里昂福莫特罗是否会影响开放标签扩展试验中对主要治疗的使用。
完成先前索里昂福莫特罗研究的 OSA 参与者接受索里昂福莫特罗 75、150 或 300mg/天治疗，最长 52 周。主要疗效结局为 Epworth 嗜睡量表评分。主要治疗的使用情况总结为每夜的百分比、每夜的小时数/夜和每晚使用≥50%/夜的百分比（%）。直接从先前的 12 周研究入组且接受开放标签治疗≤40 周的参与者（n=333）报告了疗效和主要治疗的使用情况。（n=417）报告了所有参与者的安全性数据。
坚持治疗亚组（n=255）和不坚持治疗亚组（n=78）的平均 ESS 评分分别为 15.0 和 15.8（12 周研究的基线）和 6.5 和 6.8（第 40 周）。对于使用气道治疗的参与者，基线时的平均使用情况为每晚 90%、每夜 6.6 小时/夜，每晚使用≥50%/夜的比例为 90%；从基线到第 40 周的变化很小（分别为 0.9%、-0.8 小时和 6.5%）。常见不良事件（两个亚组）包括头痛、鼻咽炎、失眠、口干、恶心、焦虑和上呼吸道感染。
无论是否坚持主要 OSA 治疗，索里昂福莫特罗的长期疗效和安全性均相似。索里昂福莫特罗未影响主要治疗的使用。
注册处：ClinicalTrials.gov；名称：JZP-110 在发作性睡病或 OSA 患者治疗过度嗜睡中的长期安全性研究；网址：https://clinicaltrials.gov/ct2/show/NCT02348632；标识符：NCT02348632 和注册处：欧盟临床试验登记册；标识符：2014-005489-31；网址：https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-005489-31。
