Aims: The purpose of the present paper was to evaluate the effectiveness of mirtazapine orally disintegrating tablets for nausea and sleep disturbance, which are common and distressing symptoms of cancer.
Methods: This was a 4-week, prospective, open-labeled study of cancer patients. Assessments were performed at baseline and on days 1, 3, 5, 7, 14, and 28. Primary outcome measures were the Clinical Global Impression scale for nausea/vomiting and the Chonnam National University Hospital-Leeds Sleep Evaluation Questionnaire (C-LSEQ) including total amount of night sleep time. The secondary outcome measures consisted of pain items in the 36-item Short Form Health Survey, the Montgomery-Asberg Depression Rating Scale (MADRS), and the EuroQoL (EQ)-5D. Forty-two cancer patients were enrolled.
Results: Those with nausea (n = 28) improved significantly from day 1. The total night sleep time and each item on the C-LSEQ improved from days 1-5. The scores on the MADRS and the depression/anxiety dimension and visual analog scale of EQ-5D improved significantly from the first week. Pain measures also improved from day 1. Exacerbation of sleepiness developed in approximately one-third of subjects during the initial few days, but disappeared gradually.
Conclusion: In the present study mirtazapine rapidly improved nausea, sleep disturbance, pain and quality of life, as well as depression in cancer patients. Mirtazapine may be an effective treatment option in managing cancer patients with multiple distressing symptoms, including nausea and sleep disturbance.