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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380081
• Other study ID #: ZI-06-010
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2006
• Last updated: February 10, 2012
• Start date: April 2006
• Est. completion date: July 2006

Study information

• Verified date: February 2012
• Source: Transcept Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• zolpidem tartrate sublingual tablet 3.5mg
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.
• zolpidem tartrate sublingual tablet 1.75mg
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.
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Transcept Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No