Data presented at SLEEP 2021 from Study 303 suggest that long-term use of lemborexant is well received by patients, who reported that the agent helped them fall asleep and improved total sleep time.
New 12-month data from Study 303 (NCT02952820) suggest that the majority of patients with insomnia who were treated with lemborexant (Dayvigo; Eisai) report experiencing a positive medication effect.1 These findings extend previous results from the study suggesting as much through 6 months of treatment.2
The data were presented by Christopher Drake, PhD, section head, Sleep Research, Henry Ford Hospital, the 2021 SLEEP Virtual Annual Meeting, June 10-13.Ultimately, Study 303 included 949 individuals with insomnia randomized to either 5-mg lemborexant (n = 316), 10-mg lemborexant (n = 315), or placebo (n = 318). The study consisted of 2 periods, with period 1 being a 1:1:1 randomization for 6 months, and period 2 being a continuation of treatment for those assigned a dose of lemborexant and a rerandomization to treatment for those previously on placebo for another 6 months. The patient-reported medication effect was measured using Patient Global Impression–Insomnia (PGI-I) item scores.
At month 9, more than 70% of those in both treatment arms (5 mg: 73.4% [177 of 241]; 10 mg: 76.3% [161 of 211]) reported that the therapy helped them sleep, with similar results at month 12 (5 mg: 74.6% [153 of 205]; 10 mg: 77.6% [149 of 192]). Additionally, the majority of patients reported that lemborexant increased total sleep time at both month 9 (5 mg: 62.2% [150 of 241]; 10 mg: 73.0% [154 of 211]) and month 12 (5 mg: 62.4% [128 of 205]; 10 mg: 65.1% [125 of 192]).
“These findings provide an understanding of how a patient’s overall experience of medication effects corresponds to changes in sleep parameters measured by sleep diary and may be useful to clinicians in determining whether a treatment regimen is providing the expected benefit,” Drake said in his presentation. “The PGI-I is a simple instrument that may be useful for determining the overall effectiveness of an insomnia treatment.”
As Drake alluded to, the PGI-I scores aligned with the improvements observed in subjective sleep onset and maintenance in Study 303. In that prior analysis, at the end of month 6, 45.5% of 5-mg subjects and 44.9% of 10-mg subjects had a decrease from baseline of 20 minutes or greater compared with 30.4% of placebo subjects in subjective sleep onset latency. At the end of month 12, those percentages were mostly maintained, with 40.4% and 43.3% of 5-mg and 10-mg patients, respectively, reporting at least a 20-minute decrease from baseline. Similarly, at the end of month 6, 27.8% and 30.2% of 5-mg and 10-mg subjects, respectively, had a decrease from baseline in subjective wake after sleep onset of 60 minutes or more versus 24.2% of placebo subjects. At month 12, those percentages were 27.8% of 5-mg patients and 27.7% of 10-mg patients.2
“The majority of subjects reported that the treatment strength was ‘just right,’ with subject responses remaining stable over the second 6 months,” Drake said. Additionally, reports of lemborexant treatment strength being “too weak” were stable across the timeframe of the study, supporting that tolerance to medication effects did not occur in the second 6 months of treatment.
As for safety, those who were administered 5-mg (n = 314) or 10-mg (n = 314) lemborexant continuously over both study periods combined reported that it was well tolerated. In total, less than 10% of subjects in either treatment group experienced treatment-emergent adverse events (AEs) leading to study discontinuation over 12 months of treatment. Experiencing any treatment-emergent AE was reported by 72.0% and 69.7% of individuals in the 5-mg and 10-mg groups, respectively. The most commonly reported (occurring at a rate of >10%) treatment-emergent AEs were nasopharyngitis (5mg: 13.7%; 10 mg: 13.4%), somnolence (5 mg: 9.6%; 10 mg: 14.3%), and headache (5 mg: 11.1%; 10 mg: 9.2%), with most being determined to be mild or moderate in severity.
For more coverage of SLEEP 2021, click here.