Efficacy of Oral Melatonin Versus Oral Olanzapine in Improving Sleep in Cancer Patients with Insomnia: Prospective Comparative Study
Abstract
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
Read the paper
Related studies
- A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials Evaluating the Evidence Base of Melatonin, Light Exposure, Exercise, and Complementary and Alternative Medicine for Patients with Insomnia Disorder
- Use of Melatonin and/on Ramelteon for the Treatment of Insomnia in Older Adults: A Systematic Review and Meta-Analysis
- Influence of evening light exposure on polysomnographically assessed night-time sleep: A systematic review with meta-analysis
- Use of melatonin in children and adolescents with idiopathic chronic insomnia: a systematic review, meta-analysis, and clinical recommendation
- Significant potential of melatonin therapy in Parkinson’s disease – a meta-analysis of randomized controlled trials
- Meta-Analysis: Melatonin for the Treatment of Primary Sleep Disorders
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.