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Web program helps insomniacs kick the pill habit

NCT ID NCT02720458

Symptom relief Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tested whether a simple internet-based self-help program could help people with long-term insomnia stop using sleeping pills like benzodiazepines or Z-drugs. The program used sleep restriction and stimulus control techniques. 62 adults who had been taking sleep medication for at least 3 months and wanted to quit were enrolled. The goal was to see if the online program, combined with a doctor's advice, made it easier to stop the pills compared to just tapering off alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

62 people

The number who actually took part.

Started

Oct 2016

Finished

Nov 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient complaining of persistent insomnia without co-morbidities (DSM-5) and treated for at least 3 months with monotherapy of: * Zopiclone or Zolpidem with usual doses (3.5 doses per week at least to a maximum of 14 per week) OR Intermediate half-life benzodiazepines included in the appendix 1 list with usual doses (3.5 doses per week at least to a maximum of 14 per week) * Motivated to stop hypnotic treatment (score \>5 on a 1 to 10 degrees VAS) * 18 to 75 years old, * Man or woman, * Having an internet connection, * Affiliated to a national health service, * Having given written informed consent to participate in the trial. Exclusion Criteria: * Patient with 2 psychotropic drugs or more taken daily for insomnia complaints (antidepressant, anxiolytic and antihistamine treatments will be allowed if they are prescribed for a stabilized mood and/or anxiety disorder). * Patient not believing in short-term simple self-help program * Insomnia with comorbidities other than a stabilized mood and/or anxiety disorder * Night and shift-workers, * Current Psychiatric disorder : mood disorder (depression, bipolar disorder) with a BDI score \> 19, anxiety disorder, psychosis * All sleep disorders other than persistent insomnia (clinical interview), * Progressive neurological diseases that include restless legs syndrome, * Unstable Cardiovascular disease, * Unstable respiratory or endocrinological diseases (clinical interview), * Drug addiction, alcohol addiction during the previous 6 months (clinical interview), * Having undertaken trans-meridian travel (± 3H) in the previous 1 month * Pregnant or lactating woman, * Current participation in psychotherapy.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia

Contacts and locations

Locations

  • AP-HP Hôpital Pitié-Salpétrière

    Paris, 75013, France

  • APHP Hôpital Raymond Poincaré

    Garches, 92380, France

  • APHP Hôtel-Dieu de Paris

    Paris, 75181, France

  • CHRU de Lille

    Lille, 59037, France

  • CHU de Bordeaux

    Bordeaux, 33076, France

  • CHU de Montpellier

    Montpellier, 34295, France

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