InsomniaPhase 3NCT00380081

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

A Phase 3 study testing zolpidem tartrate sublingual tablet 3.5mg and zolpidem tartrate sublingual tablet 1.75mg in people with Insomnia, run by Transcept Pharmaceuticals.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Insomnia
What is being tested?: zolpidem tartrate sublingual tablet 3.5mg and zolpidem tartrate sublingual tablet 1.75mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: No sites listed yet
Study dates: Apr 2006to Jul 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

About this study

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

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

Conditions: Insomnia
Being tested: zolpidem tartrate sublingual tablet 3.5mg, zolpidem tartrate sublingual tablet 1.75mg, Placebo
Keywords: Insomnia
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

zolpidem tartrate sublingual tablet 3.5mgDrug
Also called Intermezzo®
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 1.75mgDrug
Also called Intermezzo®
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.
PlaceboDrug
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.

Study groups in NCT00380081
Study group	Role	What they receive
placebo/zolpidem 3.5/zolpidem 1.75	Experimental	Not described Receives: Drug: zolpidem tartrate sublingual tablet 3.5mg; Drug: zolpidem tartrate sublingual tablet 1.75mg; Drug: Placebo
placebo/zolpidem 1.75/zolpidem 3.5	Experimental	Not described Receives: Drug: zolpidem tartrate sublingual tablet 3.5mg; Drug: zolpidem tartrate sublingual tablet 1.75mg; Drug: Placebo
zolpidem 3.5/placebo/zolpidem 1.75	Experimental	Not described Receives: Drug: zolpidem tartrate sublingual tablet 3.5mg; Drug: zolpidem tartrate sublingual tablet 1.75mg; Drug: Placebo
zolpidem 3.5/zolpidem 1.75/placebo	Experimental	Not described Receives: Drug: zolpidem tartrate sublingual tablet 3.5mg; Drug: zolpidem tartrate sublingual tablet 1.75mg; Drug: Placebo
zolpidem 1.75/placebo/zolpidem 3.5	Experimental	Not described Receives: Drug: zolpidem tartrate sublingual tablet 3.5mg; Drug: zolpidem tartrate sublingual tablet 1.75mg; Drug: Placebo
zolpidem 1.75/zolpidem 3.5/placebo	Experimental	Not described Receives: Drug: zolpidem tartrate sublingual tablet 3.5mg; Drug: zolpidem tartrate sublingual tablet 1.75mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Days 1 and 2 for each treatment

Secondary outcomes (11)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1 and 2 for each treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Jul 2006

First posted25 Sep 2006 (estimated)
Study startApr 2006
Primary completionJul 2006
Study completionJul 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00380081
Sponsor's protocol ID: ZI-06-010
Status last verified: Feb 2012
First submitted: 21 Sep 2006
Last updated: 14 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00380081
Acronym / sponsor ID: ZI-06-010
Conditions: Insomnia
Keywords: Insomnia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Transcept PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Jul 2006 (actual)
Study completion: Jul 2006 (actual)
First posted: 25 Sep 2006 (estimated)
Results: Posted 20 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
placebo/zolpidem 3.5/zolpidem 1.75	Experimental	Drug: zolpidem tartrate sublingual tablet 3.5mg, Drug: zolpidem tartrate sublingual tablet 1.75mg, Drug: Placebo
placebo/zolpidem 1.75/zolpidem 3.5	Experimental	Drug: zolpidem tartrate sublingual tablet 3.5mg, Drug: zolpidem tartrate sublingual tablet 1.75mg, Drug: Placebo
zolpidem 3.5/placebo/zolpidem 1.75	Experimental	Drug: zolpidem tartrate sublingual tablet 3.5mg, Drug: zolpidem tartrate sublingual tablet 1.75mg, Drug: Placebo
zolpidem 3.5/zolpidem 1.75/placebo	Experimental	Drug: zolpidem tartrate sublingual tablet 3.5mg, Drug: zolpidem tartrate sublingual tablet 1.75mg, Drug: Placebo
zolpidem 1.75/placebo/zolpidem 3.5	Experimental	Drug: zolpidem tartrate sublingual tablet 3.5mg, Drug: zolpidem tartrate sublingual tablet 1.75mg, Drug: Placebo
zolpidem 1.75/zolpidem 3.5/placebo	Experimental	Drug: zolpidem tartrate sublingual tablet 3.5mg, Drug: zolpidem tartrate sublingual tablet 1.75mg, Drug: Placebo

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
zolpidem tartrate sublingual tablet 3.5mgAlso: Intermezzo®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.	Drug	placebo/zolpidem 1.75/zolpidem 3.5, placebo/zolpidem 3.5/zolpidem 1.75, zolpidem 1.75/placebo/zolpidem 3.5, zolpidem 1.75/zolpidem 3.5/placebo, zolpidem 3.5/placebo/zolpidem 1.75, zolpidem 3.5/zolpidem 1.75/placebo
zolpidem tartrate sublingual tablet 1.75mgAlso: Intermezzo®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.	Drug	placebo/zolpidem 1.75/zolpidem 3.5, placebo/zolpidem 3.5/zolpidem 1.75, zolpidem 1.75/placebo/zolpidem 3.5, zolpidem 1.75/zolpidem 3.5/placebo, zolpidem 3.5/placebo/zolpidem 1.75, zolpidem 3.5/zolpidem 1.75/placebo
PlaceboPlacebo 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.	Drug	placebo/zolpidem 1.75/zolpidem 3.5, placebo/zolpidem 3.5/zolpidem 1.75, zolpidem 1.75/placebo/zolpidem 3.5, zolpidem 1.75/zolpidem 3.5/placebo, zolpidem 3.5/placebo/zolpidem 1.75, zolpidem 3.5/zolpidem 1.75/placebo

Primary outcome

Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
Time frame: Days 1 and 2 for each treatment
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.

11 secondary outcomes

Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
Time frame: Days 1 and 2 for each treatment
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
Time frame: Days 1 and 2 for each treatment
Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening
Time frame: Days 1 and 2 for each treatment
Subjective Sleep Quality Rating
Time frame: Days 1 and 2 for each treatment
Subjective Level of Refreshed Sleep
Time frame: Days 1 and 2 for each treatment
Subjective Ability to Function
Time frame: Days 1 and 2 for each treatment
Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening
Time frame: Days 1 and 2 for each treatment
Subjective Sleep Onset Latency After Middle-of-the-Night Awakening
Time frame: Days 1 and 2 for each treatment
Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening
Time frame: Days 1 and 2 for each treatment
Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening
Time frame: Days 1 and 2 for each treatment
Polysomnography Number of Awakenings After Middle-of-the-Night Awakening
Time frame: Days 1 and 2 for each treatment

Results and safety

Results posted to the registry on 20 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/Zolpidem 3.5/Zolpidem 1.75	14	14
Placebo/Zolpidem 1.75/Zolpidem 3.5	13	13
Zolpidem 3.5/Placebo/Zolpidem 1.75	13	13
Zolpidem 3.5/Zolpidem 1.75/Placebo	15	15
Zolpidem 1.75/Placebo/Zolpidem 3.5	13	12
Zolpidem 1.75/Zolpidem 3.5/Placebo	14	13

Primary outcome: Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography

Time frame: Days 1 and 2 for each treatment. Least squares mean (95% Confidence Interval). Unit: minutes

Measure	Zolpidem 3.5 mg n = 80	Zolpidem 1.75 mg n = 82	Placebo n = 81
Value	9.69 (8.06 to 11.65)	16.89 (14.07 to 20.26)	28.12 (23.41 to 33.77)

Zolpidem 3.5 mg vs Zolpidem 1.75 mg vs Placebo: p <0.001, ANCOVA

Population analysed: Intent-to-treat population

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately one month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zolpidem 3.5 mg	0 of 80 (0%)	0 of 80 (0%)	Not reported
Zolpidem 1.75 mg	0 of 82 (0%)	0 of 82 (0%)	Not reported
Placebo	0 of 81 (0%)	0 of 81 (0%)	Not reported

Limitations and caveats (from the sponsor): Scheduled nocturnal awakening is an established method used to evaluate treatments for naturally occurring middle-of-the-night awakenings. Additional studies are needed to determine the generalizability of the findings to 'real world' conditions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Roth, PhD principal investigator

Henry Ford Hospital, Sleep Disorders and Research Center

Martin Scharf, PhD principal investigator

Tri-State Sleep Disorders Center

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing zolpidem tartrate sublingual tablet 3.5mg and zolpidem tartrate sublingual tablet 1.75mg in people with Insomnia, run by Transcept Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography (time frame: Days 1 and 2 for each treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00380081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.