Insomnia Chronic hypnotic users MedDRA version: 18.0 Level: PT Classification code 10022437 Term: Insomnia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 18.0 Level: HLT Classification code 10013662 Term: Drug and chemical abuse System Organ Class: 100000004869 MedDRA version: 18.0 Level: LLT Classification code 10053851 Term: Chronic insomnia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: LORMETAZEPAM
Product Name: Lormétazepam
Product Code: Lormétazepam
Pharmaceutical Form: Tablet
INN or Proposed INN: LORMETAZEPAM
CAS Number: 848-75-9
Current Sponsor code: LORMETAZEPAM
Ot
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient complaining of persistent insomnia (DSM-5) and treated for at least 3 months with monotherapy of: Zopiclone or Zolpidem with usual doses (4 doses per week at least to a maximum of 14 per week, see appendix 2) OR Intermediate half-life benzodiazepines included in the appendix 1 list with usual doses (4 doses per week at least to a maximum of 14 per week, see appendix 2) - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 256 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 256
Exclusion criteria
Exclusion criteria: - Patient with 2 psychotropic drugs or more taken daily. - Patient non-compliant to CBT - Night and shift-workers, - Psychiatric disorder (clinical interview): mood disorder (depression, bipolar disorder) with a BDI score > 7, anxiety disorder, psychosis - All sleep disorders other than persistent insomnia (clinical interview), - Progressive neurological diseases that include restless legs syndrome, - Cardiovascular disease other than treated hypertension (clinical interview), - 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether a short-term simple self-help program delivered by internet (sleep restriction therapy + stimulus control) facilitates hypnotic taper-to-abstinence in chronic hypnotic users (intermediate half-life benzodiazepines or Z-drugs) still reporting sleep complaints. ;Secondary Objective: 1) Percentage of patients free of hypnotics at three months 2) Effects of a short-term simple self-help program (sleep restriction therapy + stimulus control) on anxiety and depression, 3) Short- and long-term effects of a short-term simple self-help program (sleep restriction therapy + stimulus control) on objective and subjective sleep quantity, 4) Short- and long-term effect of a short-term simple self-help program (sleep restriction therapy + stimulus control) on insomnia severity, 5) Efficiency of a short-term simple self-help program (sleep restriction therapy + stimulus control) on quality of life, 6) Efficiency of a short-term simple self-help program (sleep restriction therapy + stimulus control) on withdrawal Symptoms. 7) To evaluate, in each group separately, whether pretreatment outcome expectancies predict successful tapering, 8) Reasons for non-compliance. ;Primary end point(s): Achievement of 2 weeks continuous hypnotic abstinence from the end of the gradual taper based on urinary hypnotics screening.;Timepoint(s) of evaluation of this end point: Visit 2 : Week 7 (W7) Visit 3 : Week 17 (W17) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Achievement of 3 months continuous hypnotic abstinence from the end of the gradual taper based on urinary hypnotics screening - Total sleep time, sleep efficiency, wake after sleep onset, sleep latency obtained by actimetry - Scores on insomnia scales (Insomnia Severity Scale, Leeds) - Score on depression scale (Beck Depression Inventory) - Score on anxiety scale (Beck Anxiety Inventory) - Score on quality of life questionnaire (Short-Form SF-36 Health Survey) - Score on Benzodiazepine Withdrawal Symptoms Questionnaire - Reasons for non-compliance (loss of information, loss of motivation, obstacles).;Timepoint(s) of evaluation of this end point: Visit 3 : Week 17 (W17) Visit 2 : Week 7 (W7) | — |
Countries
France
Contacts
Public ContactLeila Boukami
CHU de Bordeaux
Outcome results
None listed