0372 Association between the real-world use of GABA receptor agonists and daytime impairment in US patients with insomnia

Abstract

Abstract Introduction Currently available data inadequately quantify daytime impairment associated with insomnia disorder and the impact of its treatments in the real-world setting. The objective of this real-world study was to retrospectively examine daytime impairment symptoms before and during pharmacological treatment with non-benzodiazepine receptor agonists (non-BzRAs) and benzodiazepines in US patients with insomnia. Methods Information from HealthVerity was retrieved for patients with insomnia aged ≥ 18 years prescribed non-BzRAs or benzodiazepines as first-line treatment between October 2015 and March 2020. For each patient with data, insurance claims data were extracted alongside physician notes in free-text form. Patient demographics and prescription information were extracted from the claims. Daytime impairment symptoms were extracted and quantified from physician notes using an ontology designed with three domains (i.e., alert/cognition, mood and sleepiness) and 14 items analogous to the Insomnia Daytime Symptoms and Impact Questionnaire (IDSIQ). This ontology extends IDSIQ terms to 109 terms in total to reflect the language of physicians. The annualized rate of daytime impairment measures the frequency of symptoms occurring from 182 days before treatment start to about three months (mean) during treatment. The rate is normalized by one year as the duration before and during treatment is different. A single symptom of a visit is counted maximally once within a specific domain. Results 2361 and 1045 unique patients were prescribed non-BzRAs and benzodiazepines, respectively. Non-BzRAs treatment was associated with a statistically significant 16% overall increase of daytime impairment symptoms during versus before treatment (p=0.003). Statistically significant increase of daytime impairment symptoms with non-BzRA treatment was observed in the alert/cognitive (16%,p=0.019), mood (22%,p=0.002) domains, but only nominal increase in the sleepiness domain (12%,p=0.084). Benzodiazepine treatment was associated with a statistically significant 19% overall increase of daytime impairment symptoms during versus before treatment (p=0.047), with a statistically significant increase seen in the mood domain (26%,p=0.030) but only nominal increases in the alert/cognitive (7%,p=0.76), and sleepiness (21%,p=0.079) domains. Conclusion This study shows that treatment of insomnia with commonly used drugs (i.e. non-BzRA and benzodiazepines) is associated with an overall increase in daytime impairment symptoms in a real-world setting. Support (if any) Idorsia Pharmaceuticals Ltd.