Evaluation of Long-term Perception of Medication Effectiveness: Results from Subjects Receiving Lemborexant for up to 12 Months
Recommended Citation
Drake C, Yardley J, Pinner K, Perdomo C, Moline M. Evaluation of Long-term Perception of Medication Effectiveness: Results from Subjects Receiving Lemborexant for up to 12 Months. Sleep Med 2022; 100:S120.
Document Type
Conference Proceeding
Publication Date
12-1-2022
Publication Title
Sleep Med
Abstract
Introduction: The Patient Global Impression–Insomnia version (PGI-I) is a self-report instrument used to evaluate patients’ perceptions of the effects of their insomnia medication on their sleep relative to their sleep before the start of treatment. The PGI-I questionnaire includes 3 items related to the effects of medication (helped/worsened sleep; decreased/increased time to fall asleep; and increased/decreased total sleep; the choices for response include: 1=positive, 2=neutral, 3=negative) and 1 item related to perceived appropriateness of study medication strength (the choices for response include: 1=too strong, 2=just right, 3=too weak). In Study E2006-G000-303 (Study 303; SUNRISE-2; NCT02952820), the percentages of subjects who reported a positive impact of lemborexant (LEM) was significantly greater compared with placebo (PBO) at 1, 3, and 6mo for the PGI-I items related to the effects of medication. LEM is a dual orexin receptor antagonist approved in multiple countries, including the United States, Japan, Canada and Australia for the treatment of insomnia in adults. We present here the PGI-I results at 9 and 12mo for subjects that received continuous treatment with LEM for up to 12mo. Materials and Methods: Study 303 was a 12mo, randomized, double-blind, PBO-controlled (during the first 6mo [Period 1]), phase 3 study. Subjects were age ≥18 years with a diagnosis of insomnia disorder. During Period 1, subjects received PBO (n=318) or LEM (5mg, [LEM5], n=316; 10mg, [LEM10], n=315). During Period 2 (second 6mo), LEM subjects continued their assigned dose while PBO subjects were rerandomized to LEM5 or LEM10 (data for PBO subjects rerandomized to LEM in Period 2 reported separately). All subjects (LEM and PBO) were administered the PGI-I at 1, 3 and 6mo (previously presented). PGI-I was also administered at 9 and 12mo, and only subjects who had received LEM during Period 1 are summarized here. Results: At 9 and 12mo, the majority of LEM5 (9mo: n=241; 12mo: n=205) and LEM10 (9mo, n=211; 12mo, n=192) subjects reported that their study medication “helped” sleep at night (9mo: LEM5=73.4%; LEM10=76.3%; 12mo: LEM5=74.6%; LEM10=77.6%), reduced time to fall asleep (9mo: LEM5=79.3%, LEM10=78.2%; 12mo: LEM5=76.6%, LEM10=80.2%), and increased total sleep time (9mo: LEM5=62.2%, LEM10=73.0%; 12mo: LEM5=62.4%; LEM10=65.1%). Also, at both 9 and 12mo the majority of subjects in the LEM5 and LEM10 groups responded that their perception of the appropriateness of the strength of their treatment was “just right” (9mo: LEM5=60.6%, LEM10=62.1%; 12mo: LEM5=63.4%; LEM10=60.4%), which were higher percentages than reported “just right” at 1, 3 and 6mo (1mo: LEM5=43.7%, LEM10=43.4%; 3mo: LEM5=49.8%, LEM10=51.5%; 6mo: LEM5=55.6%; LEM10=53.4%). LEM was generally well tolerated. The majority of events were mild or moderate in severity. Conclusion: The majority of subjects receiving LEM5 or LEM10 reported a positive medication effect at both 9 and 12mo. These results are similar to positive effects for LEM achieved at earlier time points during the first 6mo of treatment in Study 303 and suggest that for the majority of subjects, a positive perception of their insomnia medication is sustained for up to 12mo. Acknowledgements: Supported by Eisai Inc.
Volume
100
First Page
S120
