Efficacy and Safety of Ramelteon versus Zolpidem in Patients of Insomnia in Tertiary Care Centre of Eastern India: A Randomised Controlled Trial

Abstract

Introduction: Anxiety disorders, severe depression, substance abuse problems, suicidal thoughts, type 2 diabetes, and hypertension can all be brought on by insomnia. Despite being regarded as a safe medication, zolpidem has been linked to a few documented side effects, including headaches, dizziness, and sleepiness when taken briefly. Alternative treatments for insomnia, such as melatonin supplements and agonists of the melatonin receptor, have been studied due to the hazards connected with non-benzodiazepine agonists of the GABA receptor. Aims/ objective: To compare the efficacy and safety of ramelteon versus zolpidem for improvement in onset, quality, and depth of sleep in patients of chronic primary insomnia. Materials and Method: Using randomly generated online numbers, 60 patients were divided into two groups: group Z and group R, each with 25 patients. Patients in the group Z were directed to take zolpidem 10 mg at bedtime for 14 days, whereas patients in the group R were advised to take ramelteon 8 mg at bedtime. The improvement in sleep latency from the baseline to day 14 was the main effectiveness outcome measure. The length of sleep, the number of awakening, quality of sleep determined by patient self-assessment, and the incidence of reflex insomnia were secondary efficacy end variables. Patient questionnaires were used to assess these parameters. Results: There was a significant decrease in subjective sleep latency in the patients receiving ramelteon (reduced from 62.95 ± 33.42 minutes at baseline to 31.02 ± 8.78 minutes; p < 0.05) and patient receiving zolpidem (reduced from 62.06 ± 43.64 minutes at baseline to 29.83 ± 7.87 minutes; p < 0.05). There was statistically significant improvement in both group R and group Z as per sleep latency, length, and quality (p<0.05). Most of the patients in receiving zolpidem or ramelteon had markedly improved sleep as per modified Clinical Global Impression scale-2. There was more incidence of headache, dizziness and anxiety in patient receiving zolpidem therapy as compared to patients on ramelteon. Conclusion: It has been demonstrated that ramelteon is just as effective as zolpidem in terms of sleep latency, length, and quality. Furthermore, there is less potential for abuse and a minimal chance of negative medication reactions such as rebound insomnia and withdrawal symptoms, learning and memory problems, and motor coordination loss.