Forenap Pharma, Rouffach, France.
Curr Med Res Opin. 2010 Jun;26(6):1423-31. doi: 10.1185/03007991003788225.
To compare the hypnotic effects of a single dose of a sublingual formulation of zolpidem (Edluar*) 10 mg vs oral formulation (Ambien dagger ) 10 mg by polysomnography (PSG) in DSM-IV primary insomnia patients. Primary objective was to compare the two formulations on sleep induction, measured by latency to persistent sleep (LPS), sleep onset latency (SOL) and latency to stage 1 (ST1L).
This was a randomized, double-blind, two-period, cross-over multi-centre study in which each period comprised two successive PSG recording nights. Treatment was administered when PSG recordings started. Subjective sleep and residual effects were assessed the next morning.
Seventy female and male patients aged 19-64 were analysed. Sublingual zolpidem significantly shortened LPS by 34% or 10.3 minutes as compared to oral zolpidem (95% CI: -4.3 min to -16.2 min, p = 0.001). SOL and ST1L were also significantly shortened (p < 0.01). Furthermore the two formulations were comparable in terms of sleep maintenance properties based on total sleep time (TST). The improvement in subjective sleep and next-day residual effects did not differ between the two treatments. Both routes of administration were well tolerated.
The results demonstrate that sublingual zolpidem is superior to an equivalent dose of oral zolpidem in terms of sleep inducing properties in a carefully selected sample of primary insomnia patients.
通过多导睡眠图（PSG）比较 10mg 舌下制剂zolpidem（Edluar*）与 10mg 口服制剂zolpidem（Ambien dagger）在 DSM-IV 原发性失眠患者中的催眠效果。主要目的是比较两种制剂在睡眠诱导方面的差异，通过潜伏期至持续睡眠（LPS）、入睡潜伏期（SOL）和潜伏期至 1 期（ST1L）来衡量。
这是一项随机、双盲、两周期、交叉多中心研究，每个周期包括连续两个 PSG 记录夜。在 PSG 记录开始时给予治疗。次日早上评估主观睡眠和残留效应。
共分析了 70 名年龄在 19-64 岁的男性和女性患者。与口服zolpidem 相比，舌下zolpidem 显著缩短 LPS 34%或 10.3 分钟（95%CI：-4.3 min 至-16.2 min，p=0.001）。SOL 和 ST1L 也显著缩短（p<0.01）。此外，两种制剂在总睡眠时间（TST）方面的睡眠维持特性相当。两种治疗方法在主观睡眠和次日残留效应方面的改善无差异。两种给药途径均耐受良好。
结果表明，在精心挑选的原发性失眠患者样本中，与等效剂量的口服zolpidem 相比，舌下zolpidem 在诱导睡眠方面具有优势。
