Phase 3
Completed N=295
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Source: ClinicalTrials.gov NCT00466193 ↗Enrolled (actual)
295
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline — 68.13; 69.42 minutes
Summary
The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline |
68.13; 69.42 | — |
| PRIMARY Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment |
38.22; 56.37 | — |
| SECONDARY Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline |
241.2; 222.9 | — |
| SECONDARY Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment |
264.1; 255.0 | — |
| SECONDARY Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. |
16.7; 11.8; 46.0; 45.1; 26.0; 27.1 | — |
| SECONDARY Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment |
30.0; 16.7; 46.0; 43.1; 17.3; 25.0 | <0.001 sig |
| SECONDARY Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline |
16.7; 11.8; 18.7; 14.6; 25.3; 32.6 | — |
| SECONDARY Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment |
30.0; 16.7; 27.3; 26.4; 26.0; 31.9 | 0.006 sig |
| SECONDARY Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline |
4.87; 4.71 | — |
| SECONDARY Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment |
5.59; 5.24 | 0.0041 sig |
Eligibility Criteria
Inclusion Criteria
- Adults with history of sleeplessness
Exclusion Criteria
- Allergic to investigational drug
- Any conditions and medications that may interfere with study drug evaluation
Data sourced from ClinicalTrials.gov (NCT00466193). 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. Informational only — not medical advice.