A bedside-savior for insomnia and anxiety disorders: melatonin/buspirone hydrochloride compound oral fast-dissolving film.

Insomnia and anxiety disorders are highly prevalent conditions that significantly impair daily functioning. Notably, a bidirectional relationship exists between these two disorders: heightened cortical excitability secondary to anxiety disrupts sleep onset mechanisms, while prolonged sleep insufficiency impairs prefrontal cortical regulation of emotional processing, thereby exacerbating anxiety symptoms. This creates a vicious cycle that worsens both conditions. To address this clinical challenge, we developed a combination therapy using two pharmacological agents with complementary mechanisms of action. Given the potential adverse neurological effects associated with conventional anxiolytics and hypnotics, we specifically selected two short-acting drugs with favorable safety profiles: melatonin and buspirone hydrochloride. To address insomnia accompanied by anxiety, we have designed and prepared a Bedside-savior:a compound oral fast-dissolving film containing melatonin and buspirone hydrochloride. Unlike traditional tablets or capsules, this immediate-release film offers distinct advantages for our target patients. Since it requires no water for administration, it prevents sleep disruption caused by nighttime drinking. Its ease of use makes it ideal for children, elderly individuals, and those with swallowing difficulties. Furthermore, the medication is rapidly absorbed through the sublingual venous plexus, enabling quick onset of action to simultaneously ease anxiety and promote faster sleep initiation-all without the need to get out of bed.