Abstract Details

Title Self-reported Perceptions of Medication Effectiveness in Subjects Receiving Lemborexant for up to 12 Months

Topic Sleep

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 1-004

Objective Evaluate patients’ long-term perceptions of the effect of lemborexant (LEM) on their sleep using the self-report instrument, Patient Global Impression–Insomnia (PGI-I).

Background PGI-I items 1-3 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) and item 4 related to perceived appropriateness of study medication strength (responses include: 1=too strong, 2=just right, 3=too weak) were assessed. In Study 303 (NCT02952820), significantly greater percentages of LEM- versus placebo (PBO)-treated subjects reported a positive impact of their medication on items 1-3 and rated medication strength as “just right” on item 4 at 1, 3, and 6mo. Results at 9 and 12mo are reported for subjects who received up to 12mo continuous LEM treatment.

Design/Methods Study 303 was a 12-mo, randomized, double-blind, PBO-controlled (first 6mo [Period 1]), phase 3 study in subjects ≥18y with 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; PBO subjects were rerandomized to LEM (reported separately).

Results

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%). Additionally, the majority of LEM-treated subjects rated treatment strength as “just right” (9mo: LEM5=60.6%, LEM10=62.1%; 12mo: LEM5=63.4%; LEM10=60.4%). LEM was well tolerated. Most adverse events were mild/moderate in severity.

Conclusions

Most LEM5- and LEM10-treated subjects reported positive medication effects and that medication strength was “just right” at 9 and 12mo, extending similar positive effects for LEM reported during Period 1.

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.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

��ɫ��

��ɫ��