Self-reported perceptions of medication effectiveness in subjects receiving lemborexant for up to 12 months
Recommended Citation
Pinner K, Drake C, Yardley J, Perdomo C, Moline M. Self-reported perceptions of medication effectiveness in subjects receiving lemborexant for up to 12 months. J Sleep Res 2022; 31.
Document Type
Conference Proceeding
Publication Date
10-20-2022
Publication Title
J Sleep Res
Abstract
Objectives/introduction: Lemborexant (LEM) is a dual orexin receptor antagonist approved in multiple countries for the treatment of adults with insomnia. The Patient Global Impression- Insomnia (PGI-I) is a self-report instrument that can be used to evaluate patients' perception of the effects of their insomnia medication. PGI-I items 1-3 are related to medication effects (helped/ worsened sleep; decreased/increased time to fall asleep; and increased/decreased total sleep; responses include: 1 = positive, 2 = neutral, 3 = negative); item 4 is related to perceived appropriateness of study medication strength (responses include: 1 = too strong, 2 = just right, 3 = too weak). In Study E2006-G000-303 (Study 303; NCT02952820), significantly greater percentages of LEM- versus placebo (PBO)-treated subjects reported a positive impact of their medication and rated medication strength as “just right” at 1, 3, and 6mo. These analyses report long-term perceptions of the effect of LEM on sleep in subjects who received LEM through 12mo. Methods: Study 303 was a 12 months, randomized, double-blind, PBO-controlled (first 6mo [Period 1]), phase 3 study in subjects age ≥18 y with insomnia disorder. During Period 1, subjects received PBO (n = 318), LEM 5 mg (LEM5; n = 316), or LEM 10 mg (LEM10; n = 315). During Period 2 (second 6 months), LEM-treated subjects continued their assigned dose, and PBO subjects were rerandomized to LEM5 or LEM10 (rerandomized subjects not reported here). The PGI-I was administered at 1, 3, 6, 9 and 12 months. Results: The majority of subjects treated (9/12 months) with LEM5 (n = 241/n = 205) and LEM10 (n = 211/n = 192) reported their study medication “helped” them sleep at night (LEM5 = 73.4%/74.6%; LEM10 = 76.3%/77.6%), reduced time to fall asleep (LEM5 = 79.3%/76.6%; LEM10 = 78.2%/80.2%), and increased total sleep time (LEM5 = 62.2%/62.4%; LEM10 = 73.0%/65.1%). Additionally, most LEM-treated subjects rated treatment strength (9/12 months) as “just right” (LEM5 = 60.6%/63.4%; LEM10 = 62.1%/60.4%); “too weak” responses did not increase over time. Rather, the percentages of those who reported medication was “just right” in Period 2 were higher than those reported in Period 1. LEM was well tolerated. Most adverse events were mild/moderate in severity. Conclusions: Most subjects treated with LEM5 or LEM10 over 12mo reported positive medication effects and perceived their medication strength as “just right”. These data support the long-term use of LEM without the development of tolerance.
Volume
31
