Effects of Melatonin and Zolpidem on Sleep Quality and General Health Status in Patients Undergoing Methadone Maintenance Treatment: A Comparative Study

Background and Aim: Substance use disorder (SUD) and the subsequent symptoms of withdrawal are likely to impact all life aspects, including poor sleep quality and low general health status. In view of that, poor sleep quality is simultaneously considered as a side effect and a risk factor. Against this background, the present study was to compare the effects of melatonin (MEL) and zolpidem (ZPD) on sleep quality and general health status in patients undergoing methadone maintenance treatment (MMT). Methods In total, 105 male patients on MMT, referred to outpatient addiction treatment centers, were divided into three groups, viz., MEL, ZPD, and placebo (PBO), using a randomized clinical trial (RCT) design with a control group (CG) (N = 35 in each group). The intervention groups were then given MEL (9 mg) 30 min before bedtime and ZPD (10 mg) right before it. At the pre- and post-intervention stages, all participants also completed the Pittsburgh Sleep Quality Index (PSQI) and the General Health Questionnaire-28 (GHQ-28). Results As compared to ZPD and PBO, MEL reduced sleep onset latency (p = 0.003) and daytime dysfunction (p = 0.043). Both MEL (p = 0.001) and ZPD (p = 0.022) further improved sleep quality, wherein the MEL group obtained a higher score. Moreover, MEL was shown to be more effective than ZPD and PBO in terms of lowering anxiety (p = 0.013) and depression (p < 0.001), as well as promoting general health status (p < 0.001). Conclusion The study results revealed that MEL could successfully enhance sleep quality and general health status in patients on MMT in comparison to ZPD and PBO. Trial Registration The research protocol has been also listed on the Iranian Registry of Clinical Trials (IRCT) with the code no. IR20201214049718N1(date: 25/01/2021)