A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 295
- 试验地点
- 1
- 主要终点
- Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
研究概览
简要总结
The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with history of sleeplessness
排除标准
- •Allergic to investigational drug
- •Any conditions and medications that may interfere with study drug evaluation
研究组 & 干预措施
Zolpidem 3.5mg
干预措施: zolpidem tartrate sublingual tablet (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
时间窗: Weeks -1 to 0
Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
时间窗: Weeks 1 to 4
Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
次要结局
- Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline(Weeks -1 to 0)
- Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment(Weeks 1 to 4)
- Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.(Weeks -1 to 0)
- Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment(Weeks 1 to 4)
- Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline(Weeks -1 to 0)
- Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment(Weeks 1 to 4)
- Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline(Weeks -1 to 0)
- Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment(Weeks 1 to 4)