Perception of Lemborexant Effectiveness as Assessed by the Patient Global Impression–Insomnia Questionnaire

Christopher L Drake,1 Jane Yardley,2 Kate Pinner,2 Margaret Moline,3 Manoj Malhotra3 1Thomas Roth Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI, USA; 2Clinical Evidence Generation, Neurology and Deep Human Biology Learning, Eisai Ltd., Hatfield, Hertfordshire, UK; 3Clinical Evidence Generation, Neurology and Deep Human Biology Learning, Eisai Inc., Nutley, NJ, USACorrespondence: Margaret Moline, Eisai Inc., 200 Metro Blvd, Nutley, NJ, 07110, USA, Email [email protected]: Using data from a clinical study of lemborexant, evaluate responses to the Patient Global Impression–Insomnia (PGI-I) questionnaire, a simple 4-item questionnaire that assesses patients’ perceptions of the effects of medication on sleep, which may help evaluate clinically meaningful changes from the patient’s perspective.Methods: Study E2006-G001-303, a 12-month, placebo (PBO)-controlled (first 6 months) Phase 3 study in adults with insomnia disorder, randomized subjects (1:1:1) to lemborexant 5 mg (LEM5; n=316), 10 mg (LEM10; n=315), or PBO (n=318). The second 6 months are not presented here. PGI-I results were analyzed post hoc in relation to patient-reported (subjective) sleep-onset latency (sSOL) and total-sleep-time (sTST).Results: At 6 months: 67.3% (LEM5) and 68.8% (LEM10) of subjects reported positive effects of medication helping them sleep versus 45.0% (both p< 0.0001) with PBO. Positive effects on “time to fall asleep” were reported by 72.8% (LEM5) and 73.1% (LEM10) versus 46.1% with PBO (p< 0.0001), and 58.0% (LEM5) and 62.0% (LEM10) reported positive effects on sleep duration versus 39.9% with PBO (p< 0.0001). Subjects reporting positive effects on “time to fall asleep” had greater change from baseline (CFB; improvement) at 6 months in median sSOL (in minutes; LEM5= − 26.8; LEM10= − 32.1; PBO= − 17.5; p< 0.01) versus those reporting negative effects (LEM5= − 9.1; LEM10= − 10.4; PBO= − 8.6; LEM5 vs PBO, p=0.52; LEM10 vs PBO, p=0.69). For sTST (in minutes) at 6 months, mean CFB tended to be greater for subjects reporting positive (LEM5=81.2, LEM10=93.2, PBO=74.8; LEM5 vs PBO, p=0.28; LEM10 vs PBO, p=0.18) versus negative (LEM5=46.4, LEM10=35.0, PBO=38.6; LEM5 vs PBO, p=0.44; LEM10 vs PBO, p=0.52) effects, although this was not statistically significant.Conclusion: Patient impressions of the effects of lemborexant were positive based on the PGI-I and reflected improvements in subjective sleep outcome measures, indicating that the brief PGI-I tool may be useful in clinical practice.Plain Language Summary: People with chronic insomnia, a common sleep disorder, have trouble falling asleep and/or staying asleep 3 or more times per week for at least 3 months. Insomnia treatments should improve sleep when measured objectively but should also improve sleep from the patient’s perspective. The Patient Global Impression–Insomnia (PGI-I) is a simple 4-item questionnaire that assesses a patient’s perceived efficacy of their sleep medication. Lemborexant is a medicine used to treat insomnia. This study evaluated the patient’s view of the success of lemborexant treatment over time. There were 316, 315, and 318 people with chronic insomnia in the lemborexant 5 mg, lemborexant 10 mg, and no active treatment (placebo) groups, respectively, in this study. People treated with lemborexant reported more positive views of their medication on the PGI-I compared with those treated with placebo. These positive impressions of lemborexant on the PGI-I were associated with improvements in related subjective measurements of sleep. These results indicate that the PGI-I is a tool that may help assess whether an insomnia treatment is working from the patient’s viewpoint.Keywords: insomnia, orexin receptor antagonist, sleep, patient-reported outcome measure