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Abstract Details

Interpreting Adverse Events of Somnolence With Lemborexant in Clinical Trials
Sleep
P6 - Poster Session 6 (5:00 PM-6:00 PM)
14-012
To discuss interpreting treatment-emergent adverse events of somnolence (TEAE-S) from 2 large phase 3 studies of lemborexant (LEM), a dual orexin-receptor antagonist approved to treat adults with insomnia.
Assessment of TEAE-S is important since residual sleepiness can lead to functional impairment. In assessing the effect of TEAE-S, incidence, severity, timing relative to treatment initiation, and impact on morning/daytime function should be considered.
Studies E2006-G000-304 (NCT02783729) and E2006-G000-303 (NCT02952820) evaluated efficacy and safety across 1 and 12 months, respectively, of LEM 5mg (LEM5), LEM 10mg (LEM10), and placebo (PBO) in adults with insomnia disorder. In addition to assessing the incidence/severity of TEAE-S, a Kaplan-Meier analysis was conducted using pooled safety data. To assess the potential for morning residual sleepiness, a highway-driving study (Study E2006-E044-106; NCT02583451) tested healthy adult and elderly participants following single and multiple doses of approved doses, LEM5 and LEM10, versus PBO and active control, zopiclone (7.5mg).
In the pooled dataset, TEAE-S was the most common TEAE, and while the overall incidence of TEAE-S was low, there was a dose-related increase in incidence. LEM5 and LEM10 consistently showed approximately 5%–6% and 7%–8% higher incidence, respectively, than PBO. Few participants discontinued due to somnolence (PBO: 0.6%; LEM5: 1.1%; LEM10: 2.3%); most TEAE-S were mild and transient. Kaplan-Meier analysis revealed that the greatest probability of a first incidence of TEAE-S occurred during the first 2 weeks, with lower probability later in the treatment period. In Study E2006-E044-106, there were no statistical differences in the standard deviation of lateral position between LEM5, LEM10, and PBO, supporting lack of driving impairment.
Incidence of somnolence was dose-dependent, but patients are advised to start on LEM5. The probability of reporting somnolence diminished after the first 2 weeks. LEM10 was not associated with driving impairment, suggesting TEAE-S do not equate with impairment. 
Authors/Disclosures
Margaret Moline
PRESENTER 		Margaret Moline has received personal compensation for serving as an employee of EISAI, INC.. Margaret Moline has received intellectual property interests from a discovery or technology relating to health care. Margaret Moline has received personal compensation in the range of $0-$499 for serving as a review, loan repayment program with NIH.
Christopher Réaume, PhD Dr. Réaume has received personal compensation for serving as an employee of Eisai.
Dinesh Kumar Dinesh Kumar has received personal compensation for serving as an employee of Eisai Inc.
Kate L. Pinner Mrs. Pinner has received personal compensation for serving as an employee of Eisai Ltd..
Jennifer Swainson, MD Dr. Swainson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for abbvie. Dr. Swainson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Swainson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. Dr. Swainson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Idorsia. Dr. Swainson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novonordisk. Dr. Swainson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Swainson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. Dr. Swainson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Elvium. Dr. Swainson has received personal compensation in the range of $500-$4,999 for serving as a advisor with College of Physicians and Surgeons of Alberta.