This study will be conducted to evaluate whether the approach of direct transitioning to
lemborexant (LEM) is supported for insomnia patients who are unsatisfied with current
Transition from Following 4 regimens of interest will be investigated; Z-Drug monotherapy,
suvorexant (SUV) monotherapy, SUV and benzodiazepine receptor agonists (BZRA) combination
therapy, and ramelteon (RMT) and BZRA combination therapy. Patients with insomnia who have
been treated with one of the regimens but do not have treatment satisfaction will be
As a comprehensive indicator of patient satisfaction including treatment efficacy and safety,
the proportion of patients with successful transitioning will be evaluated at 2 weeks after
transitioning; thus important initial response after transitioning will be evaluated as a
primary endpoint. In addition, as a secondary purpose, the treatment continuation, efficacy
and tolerability, and the treatment impression for insomnia (Patient Global Impression of
Insomnia) for 14 weeks after transitioning will be assessed.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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