Randomized Comparison Trial between low dose Quetiapine and Trazodone for treatment of Short- Term Insomnia in patients with Alcohol Dependence in Early Full Remission

This is a single-centre, randomized, open label , parallel-group trial comparing the effectiveness of Quetiapine (initial dose 12.5 mg, titrated up to 100 mg/day) and Trazodone (initial dose 25 mg, titrated up to 50 mg/day) in the management of short-term insomnia among individuals with alcohol use disorder in early full remission. Patients diagnosed with Alcohol Dependence, in early full remission presenting with short term Insomnia attending Outpatient (OP) / Inpatient (IP) services in the department of psychiatry, Mahatma Gandhi Medical College and Research Institute, Puducherry. The primary outcome will compare the change in objective sleep efficiency measured by Type 1 polysomnography from baseline to week 8 between the Quetiapine and Trazodone groups. The secondary outcome will compare the change in subjective sleep quality between the two groups, as measured by the Pittsburgh Sleep Quality Index (PSQI), severity of insomnia by Insomnia severity index (ISI) score, severity of craving by Penn Alcohol craving scale (PACS), severity of mood / Anxiety symptoms by Hospital Anxiety and Depression scale (HADS), compare the safety and tolerability of Quetiapine and Trazodone using a self-designed questionnaire for FDA listed Adverse events weekly for a total study duration of 8 weeks for each participant.