An Open Label, Prospective, Multicenter, Postmarketing Surveillance (Phase IV) Study to Evaluate the Safety, Tolerability, and Efficacy of Lemborexant in Adult Subjects (Age 18-65 Years) With Insomnia in India.

The study is an open-label, prospective, multicenter, postmarketing surveillance (Phase IV) observational study in insomnia subjects in routine clinical practice. Approximately 110 subjects who are to be initiated on lemborexant (commercial supplies labeled not to be sold) per the investigator’s discretion/judgement will be included in the study. The total study duration will be 2.5 years and will comprise data collection for 6 months for each subject

The clinical decision to initiate lemborexant will already have been made before a subject is identified for the study (i.e., the decision to prescribe lemborexant is independent of the decision to enroll the subject in the study).

Investigators will identify suitable subjects based on their information from routine clinical practice when making the clinical decision to prescribe lemborexant. Per guidelines, subjects will receive commercially available lemborexant labeled not to be sold for commercial purpose, being used for clinical trial. Data will be obtained by reviewing the subject’s medical records and records of the physician’s interviews with subjects at clinic visits. A written informed consent will be signed by the subjects prior to screening and enrolling the patient into the study.

Demography, medical history, psychiatric history, and sleep history will be collected at screening visit. Lemborexant will be prescribed according to the approved prescribing information in India and the treating physician’s clinical judgment based on individual subject’s medical condition, clinical response, and tolerability. Actual dosing will be at the discretion of each investigator, including dose escalation.

Theinitial visit (screening) will be followed by 3 study visits at approximately 1month, 3 months, and 6 months postbaseline, in accordance with routine clinicalpractice (see schedule of procedures and assessments).  At each clinic visit, lemborexant doseadjustments and reasons, concomitant medications, and adverse events (AEs) willbe collected. Abnormal results from any clinical investigations, eg, ECG (ifavailable), laboratory samples (if available) or vital signs will be reportedas AEs. At each clinic visit, the PGI‑I questionnaire will be answered by thesubject.  Data from visits at other timeswill be recorded and analyzed (if available and data permitting).

Subjects will beconsidered to have completed the study if they discontinue lemborexant and haveat least one post-discontinuation assessment, or if they complete the Visit 4(Month 6) assessments, whichever is sooner. Subjects who are lost to follow-upand are unable to fulfill these conditions will be considered not to havecompleted the study. The maximum estimated duration for each subject on studyis anticipated to be approximately 6 months.

The collectedobservational data will be recorded from the start of lemborexant treatment to6 months (Visit 4). All observational data will be recorded by theinvestigator as part of routine clinical practice.

The end of the study will be the date of thelast study visit for the last subject in the study.