Groupe Hospitalier Pitié-Salpêtrière, Unité des Pathologies du Sommeil, Paris, France.
Sleep Med. 2011 Jun;12(6):550-6. doi: 10.1016/j.sleep.2011.03.010. Epub 2011 May 14.
The benefit/risk ratio of modafinil was recently re-evaluated by the European Medicines Agency and was shown to be negative for idiopathic hypersomnia (IH) because of insufficient data.
To evaluate the benefit/risk ratio of modafinil in idiopathic hypersomnia (with and without long sleep time) vs. narcolepsy/cataplexy.
The benefit (Epworth sleepiness score, ESS; visual analog scale, patient and clinician opinions) and risks (habituation, adverse effects) of modafinil were studied in a consecutive clinical cohort of 104 IH patients (59 with long sleep time) and 126 patients with narcolepsy/cataplexy.
Modafinil was the first line treatment in 96-99% of patients. It produced a similar ESS change in IH patients and in narcolepsy patients (-2.6±5.1 vs. -3±5.1) and a similar benefit as estimated by the patients (6.9±2.7 vs. 6.5±2.5 on a visual analog scale) and clinicians. The ESS change was lower in IH patients with long sleep time than in those without. Sudden loss of efficacy and habituation were rare in both groups. Patients with IH reported similar but more frequent adverse effects with modafinil than narcolepsy patients: nervousness (14%), palpitations (13%), and headache (11%).
Modafinil has an excellent benefit/risk ratio in idiopathic hypersomnia, with or without long sleep time, similar to its effect on narcolepsy/cataplexy.
欧洲药品管理局最近重新评估了莫达非尼的获益/风险比，由于数据不足，其对特发性嗜睡症（IH）的获益/风险比为负。
评估莫达非尼在特发性嗜睡症（伴或不伴长睡眠时相）与发作性睡病/猝倒中的获益/风险比。
在连续的临床队列中，研究了莫达非尼在 104 例 IH 患者（59 例伴长睡眠时相）和 126 例发作性睡病/猝倒患者中的获益（Epworth 嗜睡量表评分、患者和医生的意见）和风险（适应性、不良反应）。
莫达非尼是 96%-99%患者的一线治疗药物。它在 IH 患者和发作性睡病患者中产生了相似的 ESS 变化（-2.6±5.1 对-3±5.1），并得到了患者（6.9±2.7 对 6.5±2.5）和医生的类似评估。伴长睡眠时相的 IH 患者的 ESS 变化低于不伴长睡眠时相的患者。在两组患者中，突然失效和适应性不良都很少见。IH 患者报告的莫达非尼不良反应与发作性睡病患者相似，但更常见：神经质（14%）、心悸（13%）和头痛（11%）。
莫达非尼在特发性嗜睡症（伴或不伴长睡眠时相）中具有极好的获益/风险比，与发作性睡病/猝倒相似。
