Phase 3 N=295 Randomized Double-blind Treatment

A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT00466193 ↗

Enrolled (actual)

295

Serious AEs

0.0%

Results posted

Jan 2012

Primary outcome: Primary: Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline — 68.13; 69.42 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: zolpidem tartrate sublingual tablet (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Transcept Pharmaceuticals
Primary completion: Nov 2007

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

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.

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

View full record on ClinicalTrials.gov →

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.