Temazepam or Melatonin Versus Placebo for the Treatment of Insomnia in Advanced Cancer: A Three-Arm, Double-Blind, Phase III, Multicenter, Randomized Clinical Trial

Mendis, R; Wong, A; Frenkel, S; Southcott, AM; Selman, CJ; Martin, J; Grobler, A; Currow, D; Agar, M; Le, B; Philip, J

Author(s): Mendis, R; Wong, A; Frenkel, S; Southcott, AM; Selman, CJ; Martin, J; Grobler, A; Currow, D; Agar, M; Le, B; Philip, J;
Details: Publication Year 2024-10,Volume 27,Issue #10,Page 1368-1373
Journal Title: Journal of Palliative Medicine
Publication Type: Research article
Abstract: Background: Sleep disturbance has a prevalence of 30-78% in patients with advanced cancer. While pharmacotherapy is common, randomized controlled studies (RCTs) investigating available agents are limited. This study examines the efficacy and safety of temazepam or melatonin versus placebo for sleep in advanced cancer. Methods: This is a multicenter, randomized, double-blind, placebo-controlled study of temazepam, melatonin prolonged release (PR) or placebo for insomnia in patients with advanced cancer, and an insomnia severity index (ISI) score of >11. Results: Twenty-one participants were randomized: nine to temazepam, eight to melatonin, and four to placebo. Baseline characteristics between groups were similar. The adjusted mean difference in day 8 ISI score versus placebo was -9.1 (95% confidence interval [CI] -17.5, 0.7, p = 0.04) for temazepam and -9.6 (95% CI -18,-1.2, p = 0.03) for melatonin PR. There was no improvement in global quality of life. Both agents were well tolerated. Conclusion: Temazepam and melatonin PR were associated with a clinically significant improvement in patient-reported insomnia severity compared with placebo. Findings need confirmation with larger patient numbers.
Publisher: Mary Ann Liebert
Keywords: Humans; *Sleep Initiation and Maintenance Disorders/drug therapy; Male; Double-Blind Method; Female; *Melatonin/therapeutic use/administration & dosage; Middle Aged; Aged; *Neoplasms/complications/drug therapy; *Temazepam/therapeutic use/administration & dosage; Adult; Hypnotics and Sedatives/therapeutic use/administration & dosage; Placebos; Treatment Outcome; Quality of Life; Aged, 80 and over; advanced cancer; double-blind; insomnia; melatonin; phase III trial; placebo; randomized controlled trial; sleep; temazepam
Department(s): Palliative Care
Publisher's Version: https://doi.org/10.1089/jpm.2024.0151
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-11-07 06:54:32

Last Modified: 2024-11-07 06:54:57