Margaret Moline, PhD

Improvements in Daytime Functioning With Lemborexant Treatment

Daytime impairment can be assessed by items 4-7 of the 7-item Insomnia Severity Index. Here we report the impact of lemborexant (LEM) versus placebo on shifts in daytime-function-specific...

Margaret Moline , PhD;

10/26/2023

The Effect of Dual Orexin Receptor Antagonists on Next-Day Driving: A Systematic Review and Meta-Analysis

This meta-analysis of dual orexin receptor antagonists illustrates that the impact of treatment on next-day driving performance varies across treatments within the DORA drug class.

Margaret Moline , PhD;

10/26/2023

Post hoc Analysis of the Efficacy and Safety of Lemborexant in Adults with Insomnia Disorder and Depression History

Introduction: Study 303 (SUNRISE-2; NCT02952820) evaluated lemborexant (LEM) efficacy in subjects with insomnia. This post-hoc analysis examined sleep outcomes in the subgroup of subjects...

Larry Culpepper , MD;

Andrew Krystal , MD;

Jane Yardley , PhD;

Kate Pinner , MSc;

Naoki Kubota ;

Margaret Moline , PhD;

Jess Amchin , MD, JD;

Norman Atkins Jr., MBA, PhD;

Manoj Malhotra , MD;

Andrew Nierenberg , MD, MGH;

10/08/2020

Impact of Lemborexant on Patient-Reported Insomnia-Related Worry/Distress and Interference With Daily Functioning Over 6 Months: Results From SUNRISE-2

INTRODUCTION: The insomnia severity index (ISI) is a self-report instrument that evaluates perception of insomnia severity. In Study 303 (SUNRISE-2), lemborexant (LEM) showed greater red...

Rakesh Jain , MD, MPH, RD;

Jane Yardley , PhD;

Kate Pinner , MSc;

Manoj Malhotra , MD;

Margaret Moline , PhD;

Norman Atkins Jr., MBA, PhD;

Craig Chepke , MD, DFAPA;

10/08/2020

Effect of Lemborexant Treatment Across 12 Months on Fatigue Severity and Sleep Outcomes in Subjects With Clinically Significant Fatigue at Baseline

Introduction: The Fatigue Severity Scale (FSS) assesses impact of fatigue on patients’ lives. Lemborexant (LEM) efficacy was examined in the subgroup of subjects with baseline FSS total s...

Norman Atkins Jr., MBA, PhD;

Craig Chepke , MD, DFAPA;

Rakesh Jain , MD, MPH, RD;

Jane Yardley , PhD;

Manoj Malhotra , MD;

Kate Pinner , MSc;

Margaret Moline , PhD;

10/08/2020

Effectiveness and Safety of Lemborexant in Subjects Previously Treated with Placebo for 6 Months in SUNRISE-2

Introduction: In Study 303 (SUNRISE-2; NCT02952820), while lemborexant (LEM) provided significant benefit versus placebo (PBO) on sleep-diary measurements over 6mo, some improvement was ...

Margaret Moline , PhD;

Yuichi Inoue , MD, PhD;

Carlos Perdomo , MSc;

Jane Yardley , PhD;

Gleb Filippov , MD;

Kate Pinner , MSc;

Naoki Kubota ;

10/08/2020

Subjective Ratings of Medication Strength of Lemborexant Over 6 Months in Subjects With Moderate or Severe Insomnia

Abstract: Introduction: A concern with sedative-hypnotic medication for the treatment of insomnia is the development of tolerance. The Patient Global Impression–Insomnia (PGI-I) and Insom...

Margaret Moline , PhD;

Gillian Anderson ;

01/19/2023

The Incidence of Abnormal Dreams and Nightmares in Adults With Insomnia Treated With Lemborexant: Results From Two Phase 3 Studies

Abstract: Introduction: Abnormal dreams and nightmares are reported by patients with insomnia both before and after treatment with hypnotics. Dual orexin receptor antagonists such as lemb...

Margaret Moline , PhD;

Gillian Anderson ;

01/19/2023

Impact of Lemborexant on Daytime Sleepiness/Alertness in Subjects With Insomnia Disorder and Baseline Sleepiness

Some sleep medications may cause morning sleepiness due to sedative side effects. This post-hoc analysis of Study 304 showed that lemborexant (LEM), a competitive dual orexin receptor ant...

Margaret Moline , PhD;

10/26/2023