Primary InsomniaPhase 4NCT01896336
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
A Phase 4 study testing Zolpidem Hemitartrate in people with Primary Insomnia, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Zolpidem Hemitartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Feb 2013to 10 Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or women aged between 20 and 64 years;
- Diagnosis of primary insomnia according to criteria defined by DSM-IV;
- Difficulty in maintaining sleep and waking up until 3 am;
- Not having used any psychoactive drug in the last 30 days prior to their inclusion in the study;
- Signature of IC.
Who cannot join
- Previous history of serious medical illness, neurological or psychiatric disorder;
- Allergy or hypersensitivity to zolpidem;
- Obstructive Sleep Apnea syndrome;
- Polysomnography with apnea and hypopnea index >10/hour or PLM >15/h;
- Other secondary sleep disorders;
- History of substance abuse or dependence;
- History of daily consumption of alcoholic beverages;
- Pregnancy, lactation or refusal to use safe contraceptive methods during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Study, Phase IV, Single-center, Double-blind, Randomized, Parallel, Controlled by 10 mg Oral Zolpidem, in Evaluating the Efficacy and Safety of Zolpidem 5 mg Sublingual in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.
Read the detailed description
- National study, phase IV, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral.
- Experiment duration: 93 days.
- 05 visits (days -3, 0, 15, 45 and 90).
- Efficacy will be evaluated for: Sleep induction and the maintenance of sleep.
- Adverse events evaluation.
- Conditions
- Primary Insomnia
- Being tested
- Zolpidem Hemitartrate
- 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 HemitartrateDrug
Also called Patz - 5mg sublingual zolpidem hemitartrate, Stilnox - 10mg oral zolpidem hemitartrate
Patz - 5mg sublingual zolpidem hemitartrate
1 QD
Stilnox - 10mg oral zolpidem hemitartrate
1 QD
| Study group | Role | What they receive |
|---|---|---|
| 5mg sublingual Zolpidem hemitartrate | Experimental | 1 QD Receives: Drug: Zolpidem Hemitartrate |
| 10 mg oral Zolpidem hemitartrate | Active comparator | 1 QD. Receives: Drug: Zolpidem Hemitartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be measured by sleep induction and maintenance.
Sleep induction is measured by time to sleep after administration of the investigational product.
The maintenance will be measured by the use of medication in the middle of the night and also by the elapsed time to sleep after administration of the investigational drug.
Measured: 90 days
Secondary outcomes (1)
Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study start18 Feb 2013
- Primary completion11 Nov 2013
- Study completion10 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Associação Fundo de Incentivo à Pesquisa
- Responsible party
- Sponsor
- Investigators
- Dalva R Poyares, MD, Principal investigator, Associacao Fundo de Incentivo a Psicofarmcologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896336
- Sponsor's protocol ID
- ZPDEMS1011
- Status last verified
- Feb 2021
- First submitted
- 8 Jul 2013
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castro LS, Otuyama LJ, Fumo-Dos-Santos C, Tufik S, Poyares D. Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial. Braz J Psychiatry. 2020 Apr;42(2):175-184. doi: 10.1590/1516-4446-2019-0389. Epub 2019 Dec 20.
PubMed 31859791
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Study, Phase IV, Single-center, Double-blind, Randomized, Parallel, Controlled by 10 mg Oral Zolpidem, in Evaluating the Efficacy and Safety of Zolpidem 5 mg Sublingual in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
- ClinicalTrials.gov ID
- NCT01896336
- Acronym / sponsor ID
- ZPDEMS1011
- Conditions
- Primary Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Collaborators
- Associação Fundo de Incentivo à Pesquisa
- Study start
- 18 Feb 2013 (actual)
- Primary completion
- 11 Nov 2013 (actual)
- Study completion
- 10 Dec 2013 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
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 the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.
Detailed description
- National study, phase IV, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral.
- Experiment duration: 93 days.
- 05 visits (days -3, 0, 15, 45 and 90).
- Efficacy will be evaluated for: Sleep induction and the maintenance of sleep.
- Adverse events evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5mg sublingual Zolpidem hemitartrate | Experimental | Drug: Zolpidem Hemitartrate1 QD |
| 10 mg oral Zolpidem hemitartrate | Active comparator | Drug: Zolpidem Hemitartrate1 QD. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men or women aged between 20 and 64 years;
- Diagnosis of primary insomnia according to criteria defined by DSM-IV;
- Difficulty in maintaining sleep and waking up until 3 am;
- Not having used any psychoactive drug in the last 30 days prior to their inclusion in the study;
- Signature of IC.
Key exclusion criteria (8 listed)
- Previous history of serious medical illness, neurological or psychiatric disorder;
- Allergy or hypersensitivity to zolpidem;
- Obstructive Sleep Apnea syndrome;
- Polysomnography with apnea and hypopnea index >10/hour or PLM >15/h;
- Other secondary sleep disorders;
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 HemitartrateAlso: Patz - 5mg sublingual zolpidem hemitartrate, Stilnox - 10mg oral zolpidem hemitartratePatz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD | Drug | 10 mg oral Zolpidem hemitartrate, 5mg sublingual Zolpidem hemitartrate |
Primary outcome
Efficacy will be measured by sleep induction and maintenance.
Time frame: 90 days
Sleep induction is measured by time to sleep after administration of the investigational product. The maintenance will be measured by the use of medication in the middle of the night and also by the elapsed time to sleep after administration of the investigational drug.
1 secondary outcome
Safety will be evaluated by the adverse events occurrences
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 31859791Castro LS, Otuyama LJ, Fumo-Dos-Santos C, Tufik S, Poyares D. Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial. Braz J Psychiatry. 2020 Apr;42(2):175-184. doi: 10.1590/1516-4446-2019-0389. Epub 2019 Dec 20.
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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.
Dalva R Poyares, MD principal investigator
Associacao Fundo de Incentivo a Psicofarmcologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem Hemitartrate in people with Primary Insomnia, run by EMS at 1 site in Brazil.
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 8 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy will be measured by sleep induction and maintenance. (time frame: 90 days). 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 NCT01896336, which also lists 1 linked publication.
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 24 Feb 2021.