Aims: A discrepancy often exists between patient-reported (subjective) and polysomnography-assessed (objective) sleep data. We examined the impact of sleep state misperception on treatment response with lemborexant (LEM), a dual orexin-receptor antagonist, in adults with insomnia.
Methods: Study 304 (E2006-G00-304) was a 1-month, randomized, double-blind, placebo (PBO)/active-controlled study. Adults ≥55 years with insomnia disorder received LEM 5 mg (LEM5), LEM 10 mg (LEM10), zolpidem tartrate extended-release (ZOL), or PBO. Baseline misperception was assessed using 2 methods. For method 1, a traditional misperception index was calculated for all participants using objective and subjective total sleep time [(TST-sTST)/TST]. For method 2, differences between objective and subjective assessments of sleep onset latency (latency to persistent sleep [LPS]-subjective sleep onset latency [sSOL]) and wake after sleep onset (WASO-sWASO) were calculated. For each method, participants were classified into quartiles (Q) based on degree of misperception.
Results: N=1006 participants were randomized (LEM5, n=266; LEM10, n=269; ZOL, n=263; PBO, n=208) and divided into Q1–4 by degree of misperception at baseline. For method 1, changes from baseline in subjective and objective sleep parameters were greater in both LEM groups compared with PBO across Q1/Q2–3/Q4. Similar results for LEM were found for misperception calculated for LPS and WASO (method 2). Overall, improvements in sleep parameters with LEM tended to be greater in those with extreme misperception (Q1, Q4), although improvements were seen across all subgroups.
Conclusions: LEM improved objective and subjective sleep parameters in patients with insomnia, regardless of the magnitude and direction of sleep state misperception.