Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia

Inclusion Criteria: * Age Range: 18-99 years old. * Patients with a current major depressive episode according to DSM-5, in a stable phase (defined as at least 4 weeks without significant changes in antidepressant treatment and no psychiatric hospitalizations in the previous 8 weeks) and with moderate or greater severity, as indicated by a total score of * 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS). * Insomnia disorder confirmed according to DSM-5 * Insomnia Severity: Insomnia Severity Index (ISI) score = o \>15. * Medication Stability defined by : * Stable doses of antidepressants, mood stabilizers, or antipsychotics for at least 1 month prior to baseline (T0). * Melatonin, Benzodiacepines, sedative antidepressants or sedative antipsychotics use for insomnia should follow a wash out protocol described below. * Informed Consent: Ability and willingness to provide written informed consent. * Acceptance of Protocol Requirements: Agreement to adhere to all scheduled visits, treatment plans, and study procedures. Exclusion Criteria: * Other Current Psychiatric Disorders: Any current psychiatric disorder other than major depressive disorder (e.g., active psychotic disorders, mania, hypomania, acute schizophrenia, schizoaffective disorder). * Use of Non-Permitted Sleep Medications: Concurrent use of melatonin, benzodiazepines, sedative antidepressants or sedative antipsychotics use for insomnia not allowed by the protocol and unwillingness to fo…