Effects of cognitive-behavioral therapy for insomnia during sedative-hypnotics withdrawal on sleep and cognition in older adults

Objectives Our objective was to assess the effect of cognitive-behavioral therapy for insomnia (CBTi) on subjective and objective sleep quality (including sleep spindles) and cognition during a sedative-hypnotics withdrawal program in older adults with insomnia disorder.

We performed a two-arm randomised controlled trial (RCT) of a sedative-hypnotic withdrawal plan alone (WPo group) or combined with CBTi (WP+CBTi group) in 47 older adults with insomnia disorder over a sixteen-week period. Our primary outcomes were change in self-reported insomnia severity (Insomnia Severity Index (ISI)), sleep efficiency (SE) from sleep diaries, and change in SE and spindle density from polysomnographic (PSG) recordings collected at baseline and at post-intervention (16 weeks). Secondary outcomes included other sleep changes from PSG, actigraphy and sleep diaries, sleep and mood questionnaires and neuropsychological assessments (manual dexterity, attention/concentration, verbal inhibition, visuo-spatial abilities).

The withdrawal program was effective in achieving discontinuation and reducing insomnia severity, with similar success with and without CBTi. The combined intervention additionally improved subjective sleep quality and prevented the decrease in subjective sleep duration induced by sedative-hypnotic discontinuation. Neither intervention significantly impacted objective sleep architecture or cognitive performance. Furthermore, reduction in sleep spindle density was observed with combined CBTi and withdrawal, but not with withdrawal alone.

Both withdrawal alone and sedative-hypnotic withdrawal combined with CBTi effectively facilitated discontinuation and reduced insomnia severity, with the combined intervention further enhancing subjective sleep quality and preserving sleep duration. Although neither approach significantly impacted objective sleep architecture or cognitive performance, the potential reduction in sleep spindle density linked to the combined intervention warrants further investigation. STATEMENT OF SIGNIFICANCE This study evaluated the combined effects of CBTi and sedative-hypnotic withdrawal on both subjective and objective sleep outcomes, such as sleep spindle density, as well as cognitive performance, in older adults with insomnia disorder. Findings reveal that CBTi, when combined to sedative-hypnotic withdrawal program, not only supports withdrawal success and reduces insomnia severity but also enhances subjective sleep quality and maintains sleep duration, which may be compromised by withdrawal alone. The observed reduction in sleep spindle density, linked to the combined intervention, needs further investigation. These results provide valuable insights into optimizing sedative-hypnotic discontinuation strategies for older adults experiencing chronic insomnia. Competing Interest Statement The authors have declared no competing interest. Clinical Trial ISRCTN10037794 Funding Statement This research was supported by grants from the Canadian Institutes of Health Research (MOP 142191, PJT 153115) to TDV and JPG, from the Natural Sciences and Engineering Research Council of Canada to TDV, from the Centre de Recherche de l Institut Universitaire de Geriatrie de Montreal and from Concordia University to TDV. SG and TDV are supported by a Senior Research Scholar award from the Fonds de recherche du Quebec-Sante (FRQS). LB has been supported by the CIHR-SPOR Chair in Innovative, Patient-Oriented, Behavioural Clinical Trials, Concordia University. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: the Comite d Ethique de la Recherche of the Institut Universitaire de Geriatrie de Montreal gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data produced in the present study are available upon reasonable request to the authors - AASM - American Academy of Sleep Medicine - AHI - Apnea-hypopnea index - BZD - Benzodiazepine - BZRA - Benzodiazepine Receptor Agonist or Z-drugs - CBTi - Cognitive-behavioral therapy for insomnia - CRIUGM - Centre de recherche de l’institut universitaire de gériatrie de Montréal - DSST - Digit Symbol Substitution Test - DKEFS - Delis-Kaplan executive function system (Stroop) - ECG - Electrocardiogram - EEG - Electroencephalogram - EMG - Electromyogram - EOG - Electrooculogram - ESS - Epworth sleepiness scale - FCSRT - French adaptation of the 16-items free and cued selective reminding test - GABA - Gamma-aminobutyric acid - GAI - Geriatric anxiety inventory - GDS - Geriatric depression scale - Hz - Hertz - ICSD - International Classification of Sleep Disorder - ISI - Insomnia severity index - MINI - Mini-international neuropsychiatric interview - MMSE - Mini-mental state examination - MoCA - Montreal cognitive assessment - MTCF/ROCF - Rey complex figure & modified Taylor complex figure tests - NREM - Non-rapid-eye-movement - N1 - NREM stage 1 - N2 - NREM stage 2 - N3 - NREM stage 3 - PLMI - Periodic limb movement index - PPT - Purdue Pegboard Test - PSG - Polysomnography - PSQI - Pittsburgh sleep quality index - REM - Rapid-eye-movement - RCT - Randomised controlled trial - SD - Standard deviation - SE - Sleep efficiency - s - Second - SES - sociodemographic variables (age, education level, and sex) - SFI - Sleep fragmentation index - SO - Slow oscillation - SL - Sleep latency - SOL - Sleep onset latency - TIB - Time spent in bed - TMT - Trail Making Test - TST - Total sleep time - WASO - Wake after sleep onset - WP+CBTi - Withdrawal Plan + CBTi Group - WPo - Withdrawal Plan alone Group - μV - microvolts