Phase 3
N=82
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00380081 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography — 9.69; 16.89; 28.12 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- zolpidem tartrate sublingual tablet 3.5mg (Drug); zolpidem tartrate sublingual tablet 1.75mg (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Transcept Pharmaceuticals
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography |
9.69; 16.89; 28.12 | <0.001 sig |
| SECONDARY Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening |
60; 46; 23 | <0.001 sig |
| SECONDARY Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography |
208.99; 197.80; 183.12 | <0.001 sig |
| SECONDARY Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening |
172.51; 162.36; 148.61 | <0.001 sig |
| SECONDARY Subjective Sleep Quality Rating |
18.8; 29.3; 34.6; 38.8; 37.8; 42.0 | <0.001 sig |
| SECONDARY Subjective Level of Refreshed Sleep |
17.5; 22.0; 32.1; 42.5; 41.5; 44.4 | <0.004 sig |
| SECONDARY Subjective Ability to Function |
7.5; 9.8; 18.5; 41.3; 42.7; 42.0 | 0.012 sig |
| SECONDARY Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening |
87.08; 82.63; 76.31 | <0.001 sig |
| SECONDARY Subjective Sleep Onset Latency After Middle-of-the-Night Awakening |
25.23; 28.58; 40.43 | <0.001 sig |
| SECONDARY Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening |
15.06; 15.81; 15.71 | 0.790 |
| SECONDARY Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening |
28.69; 29.43; 34.22 | 0.083 |
| SECONDARY Polysomnography Number of Awakenings After Middle-of-the-Night Awakening |
3.71; 3.70; 4.13 | 0.072 |
Summary
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00380081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.