Publication:

Safety and efficacy of ZOLSOMA tablets in patients with insomnia

Background Insomnia is difficulty falling asleep or staying asleep, even when a person has the chance to do so. Pharmacological management often relies on hypnotics such as zolpidem; however, high doses are linked to adverse effects. Combining zolpidem with melatonin, a circadian regulator with mild hypnotic activity, may enhance sleep quality while minimizing side effects. Aim of the study was to evaluate the safety and efficacy of a fixed-dose combination (FDC) of zolpidem and melatonin (ZOLSOMA-5) in patients with insomnia.

Methods This open-label, single-arm, multicentre, prospective study was conducted between October 2021 and October 2024. Participants received ZOLSOMA-5 for 30 days. Efficacy was assessed using the Pittsburgh Sleep Quality Index (PSQI), and Insomnia Severity Index (ISI). Safety was evaluated using Epworth Sleepiness Scale (ESS) and based on adverse effects.

Results Of 312 enrolled patients, 300 completed the study. Mean PSQI scores in intention-to-treat (ITT) set significantly decreased from 15.19±2.75 at baseline to 5.73±5.58 on day 30 (p<0.001). ISI scores reduced from 20.57±5.00 at baseline to 7.18±5.45 on day 30, respectively (p<0.001). ESS scores improved from 6.99±6.68 at baseline to 4.48±4.70 on day 30 (p<0.001). A total of 45 patients (14.4%) reported 60 adverse events (AEs), most commonly dizziness and nausea, the majority were mild and transient.

Conclusions The FDC of ZOLSOMA-5 demonstrated significant improvement in sleep quality, reducing insomnia severity, and alleviating daytime sleepiness, with a favourable safety profile. The combination appears to be a safe and effective short-term therapeutic option for insomnia, including in patients with psychiatric comorbidities.