Safety and real-world efficacy of lemborexant in the treatment of comorbid insomnia

Aim

To investigate the real-world effectiveness and safety of lemborexan for treating comorbid insomnia associated with other psychiatric disorders, and whether lemborexant helps reduce the dose of benzodiazepines (BZs).

Methods

This retrospective observational study was conducted on outpatients and inpatients treated by physicians of Juntendo University Hospital Mental Clinic between April 2020 and December 2021.

Results

Data of 649 patients who were treated with lemborexant were eventually enrolled. About 64.5% of patients were classified as the responder group. Response rates of ≥60% were recorded for most psychiatric disorders. Upon administration of lemborexant, diazepam-equivalent dose of BZs had been significantly reduced in participants (3.7 ± 8.2 vs. 2.9 ± 7.9, p < 0.001). The results of logistic regression analysis showed that outpatient (odds ratios: 2.310; 95% confidence interval [CI]: 1.32–4.05), shorter duration of BZ use (<1 year) (odds ratios: 1.512; 95% CI: 1.02–2.25), no adverse events (odds ratios: 10.369; 95% CI: 6.13–17.54), larger reduction of diazepam-equivalent dose of BZs upon introducing lemborexant prescription (odds ratios: 1.150; 95% CI: 1.04–1.27), and suvorexant was the replacement drug (odds ratios: 2.983; 95% CI: 1.44–6.19), which were significant predictors of good response.

Conclusion

Although this is a retrospective and observational study with many limitations, our study results suggest that lemborexant is effective and safe.