Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials

Sebastian Heidenreich; Melissa Ross; Gin Nie Chua; Dalma Seboek Kinter; Andrea Phillips-Beyer

doi:10.1093/sleep/zsac204

Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials

Sleep. 2022 Nov 9;45(11):zsac204. doi: 10.1093/sleep/zsac204.

Authors

Sebastian Heidenreich¹, Melissa Ross², Gin Nie Chua¹, Dalma Seboek Kinter³, Andrea Phillips-Beyer⁴

Affiliations

¹ Patient Centered Research, Evidera, London, UK.
² Patient Centered Research, Evidera, Bethesda, MD, USA.
³ Idorsia, Allschwil, Switzerland.
⁴ Innovus Consulting, London, UK.

Abstract

Study objectives: To elicit the trade-offs patients are willing to make between benefits and risks of medications for chronic insomnia, with the purpose of allowing a patient-centric interpretation of clinical trial data.

Methods: A discrete choice experiment (DCE) was included in the two placebo-controlled phase III trials that evaluated the efficacy and safety of daridorexant. The DCE design was informed by a two-phase qualitative study, followed by qualitative and quantitative pilot testing before fielding. Relative attribute importance (RAI) and acceptable trade-offs between benefits and risks were obtained using a mixed logit model.

Results: Preferences were elicited from 602 trial participants (68.1% female, aged 58.6 ± 14.5 years). Preferences were most affected by daytime functioning (RAI = 33.7%) as a treatment benefit and withdrawal symptoms (RAI = 27.5%) as a risk. Patients also valued shorter sleep onset (RAI = 6.4%), longer sleep maintenance (RAI = 5.4%), reduced likelihood of abnormal thoughts and behavioral changes (RAI = 11.3%), reduced likelihood of dizziness/grogginess (RAI = 9.2%), and reduced likelihood of falls at night (RAI = 6.5%). Patients were willing to make trade-offs between these attributes. For example, they would accept an additional 18.8% risk of abnormal thoughts and behavioral changes to improve their daytime functioning from difficult to restricted and an additional 8.1% risk of abnormal thoughts and behavioral changes to avoid moderate withdrawal effects.

Conclusions: Patients with insomnia were willing to make trade-offs between multiple benefits and risks of pharmacological treatments. Because patients valued daytime functioning more than sleep latency and duration, we recommend that functional outcomes and sleep quality be considered in treatment development and evaluation.

Trial registration: ClinicalTrials.gov NCT03545191 NCT03575104.

Keywords: clinical trial; discrete choice experiment; insomnia; patient preferences; phase III.

Publication types

Clinical Trial, Phase III
Research Support, Non-U.S. Gov't

MeSH terms

Choice Behavior
Female
Humans
Logistic Models
Male
Risk Assessment
Sleep
Sleep Initiation and Maintenance Disorders* / drug therapy

Associated data

ClinicalTrials.gov/NCT03545191
ClinicalTrials.gov/NCT03575104
EudraCT/2017-004642-20
EudraCT/2017-004643-20