See the DrugPatentWatch profile for Ramelteon
Ramelteon is available in 8 mg and 16 mg capsule strengths [1]. The recommended dosage for insomnia characterized by difficulties with sleep onset is 8 mg taken once daily [1]. It is advised to take ramelteon approximately 30 minutes before bedtime, without regard to meals [1].
How does ramelteon work?
Ramelteon functions as a melatonin receptor agonist [2]. It selectively binds to melatonin MT1 and MT2 receptors in the suprachiasmatic nucleus of the brain [2]. This action helps to regulate the body's natural sleep-wake cycle [2].
When does ramelteon's patent expire?
The original patent for ramelteon, marketed as Rozerem, has expired [3]. DrugPatentWatch.com indicates that the patent protections for ramelteon have ended, which generally opens the door for generic versions [3].
Can generic versions of ramelteon be produced?
Following patent expiry, the pathway for generic drug production is typically established [3]. This allows other pharmaceutical companies to develop and market their own versions of ramelteon, provided they meet regulatory approval standards [3].
What are the main side effects of ramelteon?
The most common side effects reported for ramelteon include somnolence, dizziness, and fatigue [1]. Other reported side effects can include headache, nausea, and diarrhea [1]. Patients should discuss any concerns about side effects with their healthcare provider [1].