In the study, investigators tested the impact of the study drug in a rerandomized patient population that previously received a placebo.
Different doses of Lemborexant could be beneficial for adult patients with difficulty falling asleep.
A research team, led by Jane Yardley, PhD, Eisai, reported new outcomes from placebo subjects who were rerandomized to Lemborexant during the last 6 months of a phase 3 study dubbed Study 303.
In recent studies, Lemborexant provided significant benefits on sleep-diary-based measures on sleep onset and sleep maintenance over a 6 month period when compared to placebo. However, researchers in the phase 3 study observed some improvement in subjects who had received the placebo.
In the 12-month, randomized, double-blind, global phase 3 study, the investigators examined adult patients with the clinical inability to fall asleep per DSM-5.The patients were randomized to receive either the study drug at 5 mg or 10 mg or placebo for 6 months in treatment period 1.
In the second 6 month treatment period, placebo subjects were then rerandomized to Lemborexant, while the Lemborexant treatment group continued their assigned treatments.
The investigators evaluated changes from the six-month baseline (where baseline was calculated after completion of placebo treatment) in subjective sleep onset latency (sSOL), subjective sleep efficiency (sSE), and subjective wake after sleep onset (sWASO) for the rerandomized subjects.
At baseline, the median sSOL (min) was 55.9, while the mean (SD) sSE (%) and sWASO (min) was 61.3 (17.8) and 132.5 (80.2), respectively, for placebo-treated subjects (n = 318). Baseline values, which were calculated at the six-month baseline for rerandomized placebo-Lemborexant 5 mg (n = 133) and placebo-Lemborexant 10 (n = 125) subjects, respectively (median sSOL, 31.2, 34.3; mean [SD] sSE, 70.5 [20.2], 71.1 [18.0]; and mean (SD) sWASO, 105.1 [80.6], 100.1 [84.6].
Median sSOL decreased from the six-month after 1 month (placebo-Lemborexant 5mg, -3.2; placebo-Lemborexant 10mg, -2.9) and 6 months (placebo-Lemborexant 5mg, -2.7; placebo-Lemborexant 10mg, -5.0). The mean (SD) sSE increased from the six-month baseline following 1 month (-Lemborexant 5mg, 3.9 [12.1]; placebo-Lemborexant 10mg, 3.5 [8.1]) and 6 months (placebo-Lemborexant 5mg, 3.9 [13.6]; placebo-Lemborexant 10, 4.5 [13.0]).
The mean (SD) sWASO decreased after 1 month (placebo-Lemborexant 5 mg, -8.5 [49.4]; placebo-Lemborexant 10mg, -5.7 [36.1]) and six-months (placebo-Lemborexant 5mg, -8.2 [49.0]; placebo-Lemborexant 10mg, -10.0 [58.8]).
The overall incidence of treatment-emergent adverse events were similar during treatment with the placebo (62.7%) and Lemborexant 5 mg (54.9%) and Lemborexant 10 mg (57.7%). These adverse events were consistent with incidence rates seen in the initial 6 months of treatments for patients originally randomized to Lemborexant.
“In Study 303, rerandomization to [Lemborexant] treatment was associated with additional improvement in sleep outcomes following the [placebo]-related response,” the authors wrote. “The benefit of [Lemborexant] was evident after 1 month of active treatment and was sustained through 6 months. [Lemborexant] was well tolerated.”
The study, “Lemborexant Effectiveness and Safety in Subjects Previously Treated with Placebo for 6 Months,” was published online by NEI.