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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.

Official Title
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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

Conditions
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Insomnia

Intervention / Treatment
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* Drug: zolpidem tartrate sublingual tablet 3.5mg
* Drug: zolpidem tartrate sublingual tablet 1.75mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: placebo/zolpidem 3.5/zolpidem 1.75<br> | Drug: zolpidem tartrate sublingual tablet 3.5mg<br>* Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: zolpidem tartrate sublingual tablet 1.75mg<br>* Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: Placebo<br>* Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>|
| Experimental: placebo/zolpidem 1.75/zolpidem 3.5<br> | Drug: zolpidem tartrate sublingual tablet 3.5mg<br>* Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: zolpidem tartrate sublingual tablet 1.75mg<br>* Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: Placebo<br>* Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>|
| Experimental: zolpidem 3.5/placebo/zolpidem 1.75<br> | Drug: zolpidem tartrate sublingual tablet 3.5mg<br>* Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: zolpidem tartrate sublingual tablet 1.75mg<br>* Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: Placebo<br>* Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>|
| Experimental: zolpidem 3.5/zolpidem 1.75/placebo<br> | Drug: zolpidem tartrate sublingual tablet 3.5mg<br>* Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: zolpidem tartrate sublingual tablet 1.75mg<br>* Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: Placebo<br>* Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>|
| Experimental: zolpidem 1.75/placebo/zolpidem 3.5<br> | Drug: zolpidem tartrate sublingual tablet 3.5mg<br>* Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: zolpidem tartrate sublingual tablet 1.75mg<br>* Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: Placebo<br>* Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>|
| Experimental: zolpidem 1.75/zolpidem 3.5/placebo<br> | Drug: zolpidem tartrate sublingual tablet 3.5mg<br>* Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: zolpidem tartrate sublingual tablet 1.75mg<br>* Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>* Other names: Intermezzo®;Drug: Placebo<br>* Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography | 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. | Days 1 and 2 for each treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening | 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. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes. | Days 1 and 2 for each treatment | 
| Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography | Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period. | Days 1 and 2 for each treatment | 
| Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening | The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire. | Days 1 and 2 for each treatment | 
| Subjective Sleep Quality Rating | Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent. | Days 1 and 2 for each treatment | 
| Subjective Level of Refreshed Sleep | Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent. | Days 1 and 2 for each treatment | 
| Subjective Ability to Function | Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent. | Days 1 and 2 for each treatment | 
| Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening | Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period. | Days 1 and 2 for each treatment | 
| Subjective Sleep Onset Latency After Middle-of-the-Night Awakening | Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. | Days 1 and 2 for each treatment | 
| Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening | Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period. | Days 1 and 2 for each treatment | 
| Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening | Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period. | Days 1 and 2 for each treatment | 
| Polysomnography Number of Awakenings After Middle-of-the-Night Awakening | Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period. | Days 1 and 2 for each treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia