Trazodone used off-label for insomnia is not associated with improvements in daytime impairment, according to study results presented at the 2023 Annual Meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held from June 3 to 7 in Indianapolis, Indiana.
While clinical practice guidelines recommend against the use of trazodone for insomnia, it is often used off-label to treat this condition. Researchers conducted a real-world study to assess the effects of trazodone on daytime impairment in patients with insomnia.
The researchers collected data from October 2015 through March 2020 from HealthVerity, insurance claims, and physician notes. They extracted patient demographic and prescription information from the insurance claims.
Patients included in this study were US adults aged 18 years and older who were prescribed trazodone as a first-line therapy for insomnia. The researchers developed an ontology analogous to the Insomnia Daytime Symptoms and Impact Questionnaire (IDSIQ) with 3 domains: alert/cognition, mood, and sleepiness.
The frequency of daytime impairment symptoms was measured as annualized rates and standardized by 1-year. In the study population, daytime impairment occurred starting from 182 days before treatment to approximately 3 months during treatment on average.
All symptoms documented by physicians were categorized into a specific domain. The researchers reported results according to trazodone dose: off-label insomnia treatment (<150 mg of trazodone) and approved depression dosage (≥150 mg of trazodone).
There were 1,187 patients taking doses less than 150 mg trazodone and 246 taking doses of 150 mg trazodone or greater. The annualized rate of daytime impairment for patients taking doses less than 150 mg was 139.4 for impairment symptoms before treatment and 147.5 for symptoms reported during treatment. This increase of 6% was found insignificant (P =.313).
For patients taking less than 150 mg of trazodone, the researchers found no statistically significant increases in each domain: alert/cognition (4%; P =.574), mood (10%; P =.173), and sleepiness (5%; P =.401).
The annualized rate for patients taking doses of 150 mg or greater before and during treatment was 143.5 and 142.2, respectively. This overall decrease of 1% was found insignificant (P =.941). Additionally, changes in each domain were found insignificant for this subgroup: alert/cognition (19%; P =.128), mood (14%; P =.400), and sleepiness (5%; P =.712) domains.
“Patients with insomnia prescribed trazodone show similar levels of daytime impairment before and during treatment,” the researchers concluded. “This study suggests that the use of trazodone in patients with insomnia is not associated with a decrease in daytime impairment.”
Disclosure: This research was supported by Idorsia Pharmaceuticals Ltd. Please see the original reference for a full list of disclosures.
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Büsser A, Olivieri A, Grandner M, McCall WV. Association between the real-world use of trazodone and daytime impairment in US patients with insomnia. Abstract presented at: SLEEP 2023; June 3-7, 2023; Indianapolis, IN. Abstract 0343.