Efficacy of Oral Melatonin Versus Oral Olanzapine in Improving Sleep in Cancer Patients with Insomnia: Prospective Comparative Study.

Sleep deprivation is a common concern for cancer patients. It has proven difficult to determine severity of sleep disturbances in a cancer group. Patients may fail to mention insomnia because they assume it is a common and temporary reaction to a cancer diagnosis or treatment, a condition that is frequently overlooked in cancer management. This prospective, double-blind, randomized comparative trial evaluated the efficacy and safety of oral melatonin (3 mg/day) versus oral olanzapine (5 mg/day) in 60 advanced cancer patients with insomnia over four weeks. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) and Athens Insomnia Scale (AIS) at baseline, 2nd wk, and 4th wk. Both groups demonstrated significant, time-dependent improvement in sleep parameters (p < 0.001). Melatonin showed statistically significant superiority over olanzapine in PSQI scores at week four and overall AIS scores across all time points; however, melatonin exhibited a more favorable adverse effect profile, while olanzapine was associated with somnolence, akathisia, and weight gain. Both agents are effective for cancer-related insomnia symptoms, with melatonin offering a superior tolerability advantage in the palliative setting. Larger placebo-controlled trials with objective sleep measures are warranted to confirm these findings.