Comparative efficacy of lemborexant and other insomnia treatments: a network meta-analysis

Abstract

BACKGROUND: Insomnia is a common disorder associated with a substantial burden of illness, particularly in older adults. OBJECTIVE:To compare the efficacy and safety of lemborexant with specified other insomnia treatments through a systematic literature review and network meta-analysis (NMA). METHODS:Medline and Embase were systematically searched from inception to February 2019 and updated with a targeted search of PubMed for pivotal trials in March 2021. Randomized controlled trials in adults with primary insomnia were included if they reported results following at least 1 week of treatment. Interventions of interest were specified as lemborexant, suvorexant, benzodiazepines, benzodiazepine receptor agonists (also called Z-drugs [zolpidem, eszopiclone, zaleplon, zopiclone]),

Cost-effectiveness analysis of lemborexant for treating insomnia in Japan: a model-based projection, incorporating the risk of falls, motor vehicle collisions, and workplace accidents

“…Secondly, no studies have directly compared suvorexant with lemborexant; the sSOL response rate used to measure efficacy was conservatively assumed to be the same for both drugs. The results of an NMA showed a statistically significant improvement in sSOL assessments after three months of treatment with lemborexant compared with that of suvorexant (McElroy et al, 2021 ). In addition, Kishi et al ( 2020 ) recently reported that both 5 and 10 mg lemborexant outperformed suvorexant (20/15 mg) and zolpidem ER (6.25 mg) in terms of the subjective time to sleep onset after one week.…”

“…The response rates for suvorexant and zolpidem IR were based on a network meta-analysis (NMA) aimed at providing estimates of comparative efficacy and acceptability for up to 16 pharmacological treatments, including lemborexant, for insomnia disorder in adults (McElroy et al, 2021 ). The response rate for zolpidem IR was assumed to be the same as that for zolpidem ER, as the mean decrease in sSOL from baseline at four weeks did not significantly differ [−8.3 min; 95% credible interval (Crl), −17.5 to 0.4] between zolpidem IR and zolpidem ER (McElroy et al, 2021 ), and a direct comparison of responder rates for zolpidem ER in SUNRISE 1 was available. The response rate for suvorexant was conservatively assumed to be the same as that for lemborexant, as the data describing responder rates were unavailable due to the fact that no direct comparison was performed in SUNRISE 1.…”

“…The response rate for suvorexant was conservatively assumed to be the same as that for lemborexant, as the data describing responder rates were unavailable due to the fact that no direct comparison was performed in SUNRISE 1. However, the NMA found that the difference in the mean decreases in the sSOL values from baseline at three months for lemborexant compared with that of suvorexant was −7.1 min (95% Crl; −13.2 to −0.9), a difference that was statistically significant (McElroy et al, 2021 ).…”

“…The risk of falls for untreated insomnia was derived from the general population of untreated patients with chronic insomnia from the Study of Osteoporotic Fractures (relative risk = 1.48) (Stone, Ensrud, & Ancoli-Israel, 2008 ). The risk of falls for lemborexant or suvorexant was derived from estimates of (1) the relative risk of falls for lemborexant and suvorexant compared with that of the general population for untreated patients (Stone et al, 2008 ) and (2) the NMA of the risk of falls for lemborexant-treated v. untreated patients [hazard ratio (HR) = 0.68] and v. suvorexant (HR = 0.85) (McElroy et al, 2021 ), as lemborexant and suvorexant are associated with a lower risk of falls than the risk in untreated insomnia patients. Thus, the HRs for the risk of falls for lemborexant and suvorexant compared with the risk in the general population were calculated as 1 ( = 0.68 × 1.48) and 1.26 ( = 0.85 × 1.48), respectively.…”

New drug: Lemborexant for insomnia

“…The safety profile, severe adverse events and rates of withdrawals due to adverse events were similar for lemborexant and all the other treatments. 4 …”