Patient preferences for the benefits and risks of insomnia medication in a clinical trial and real-world setting

The PAtient preferences stUdy in inSomnia (PAUSe) sub-study used a discrete choice experiment (DCE) to assess treatment preferences in patients with chronic insomnia who participated in randomized, placebo-controlled trials (NCT03545191 or NCT03575104). We conducted a replication study (PAUSe II), including real-world patients with self-reported insomnia who were recruited via online panels. The DCE required patients to choose between insomnia treatments with different attributes. The aim of the study was to assess preferences for insomnia treatment in the real-world population versus trial setting (PAUSe population). In PAUSe, there was no option to indicate a preference for not receiving treatment. To assess if the addition of an option to ‘opt out’ of treatment had an impact on patient preferences, 20% of the real-world cohort were randomized to complete a version of the DCE that included an opt-out alternative. Relative attribute importance (RAI) and acceptable trade-offs between benefits and risks were obtained using a mixed logit model. In the real-world group (n = 474), real-world opt-out group (n = 131), and the trial group (n = 602), the most important drivers of treatment preferences were improved daytime functioning and avoidance of withdrawal effects. The RAI for improved daytime functioning was 29.7%, 23.3%, and 33.6%, in the real-world group, real-world opt-out group, and trial group, respectively, and for avoidance of withdrawal effects was 33.5%, 23.3%, and 27.3%, respectively. Patients who had the opt-out alternative tended to select treatment over no treatment. Despite some differences between groups, preferences in the treatment of insomnia were strongly driven by the desire to improve daytime functioning and avoid medication withdrawal effects.