A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Efficacy and Safety of Sublingual Zolpidem Tartrate Tablet in Adult Patients With Insomnia Characterized by Difficulty Returning to Sleep After Middle-of-the-Night (MOTN) Awakening
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 主要终点
- Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
研究概览
简要总结
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Insomnia as defined by DSM-IV criteria and supported by subject diary
- •Male or female between the ages of 18-64 years
- •Body mass index (BMI) between 18-34 kg/m^2
- •Females of childbearing potential must use a medically acceptable method of contraception
- •Capable of understanding and willing to comply with study procedures and has provided informed consent
排除标准
- •Females who are pregnant, breast-feeding or have a positive pregnancy test
- •Any circadian rhythm disorder including planned travel across several time zones during the study period
- •Known hypersensitivity to Zolpidem
- •Has performed regular shift work with the past several months prior to screening
- •An acute clinically significant illness or surgery as determined by the PI within 30 days of screening
- •Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle
- •A history of psychiatric disorder as defined by DSM-IV
- •A history of drug addiction or alcohol abuse
- •Any current significant disease, unless adequately controlled with a protocol allowed medication
- •Known history of HIV or Hepatitis B or C
- •Patients who have received an investigational drug within several months of screening
研究组 & 干预措施
placebo/zolpidem 3.5/zolpidem 1.75
干预措施: zolpidem tartrate sublingual tablet 3.5mg (Drug)
placebo/zolpidem 3.5/zolpidem 1.75
干预措施: zolpidem tartrate sublingual tablet 1.75mg (Drug)
placebo/zolpidem 3.5/zolpidem 1.75
干预措施: Placebo (Drug)
placebo/zolpidem 1.75/zolpidem 3.5
干预措施: zolpidem tartrate sublingual tablet 3.5mg (Drug)
placebo/zolpidem 1.75/zolpidem 3.5
干预措施: zolpidem tartrate sublingual tablet 1.75mg (Drug)
placebo/zolpidem 1.75/zolpidem 3.5
干预措施: Placebo (Drug)
zolpidem 3.5/placebo/zolpidem 1.75
干预措施: zolpidem tartrate sublingual tablet 3.5mg (Drug)
zolpidem 3.5/placebo/zolpidem 1.75
干预措施: zolpidem tartrate sublingual tablet 1.75mg (Drug)
zolpidem 3.5/placebo/zolpidem 1.75
干预措施: Placebo (Drug)
zolpidem 3.5/zolpidem 1.75/placebo
干预措施: zolpidem tartrate sublingual tablet 3.5mg (Drug)
zolpidem 3.5/zolpidem 1.75/placebo
干预措施: zolpidem tartrate sublingual tablet 1.75mg (Drug)
zolpidem 3.5/zolpidem 1.75/placebo
干预措施: Placebo (Drug)
zolpidem 1.75/placebo/zolpidem 3.5
干预措施: zolpidem tartrate sublingual tablet 3.5mg (Drug)
zolpidem 1.75/placebo/zolpidem 3.5
干预措施: zolpidem tartrate sublingual tablet 1.75mg (Drug)
zolpidem 1.75/placebo/zolpidem 3.5
干预措施: Placebo (Drug)
zolpidem 1.75/zolpidem 3.5/placebo
干预措施: zolpidem tartrate sublingual tablet 3.5mg (Drug)
zolpidem 1.75/zolpidem 3.5/placebo
干预措施: zolpidem tartrate sublingual tablet 1.75mg (Drug)
zolpidem 1.75/zolpidem 3.5/placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
时间窗: Days 1 and 2 for each treatment
Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period.
次要结局
- Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening(Days 1 and 2 for each treatment)
- Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography(Days 1 and 2 for each treatment)
- Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening(Days 1 and 2 for each treatment)
- Subjective Sleep Quality Rating(Days 1 and 2 for each treatment)
- Subjective Level of Refreshed Sleep(Days 1 and 2 for each treatment)
- Subjective Ability to Function(Days 1 and 2 for each treatment)
- Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening(Days 1 and 2 for each treatment)
- Subjective Sleep Onset Latency After Middle-of-the-Night Awakening(Days 1 and 2 for each treatment)
- Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening(Days 1 and 2 for each treatment)
- Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening(Days 1 and 2 for each treatment)
- Polysomnography Number of Awakenings After Middle-of-the-Night Awakening(Days 1 and 2 for each treatment)