placebo + zolpidem

This combination refers to the control arm of a Phase 4 clinical trial (NCT00492232) sponsored by Takeda Pharmaceuticals, designed to evaluate whether the melatonin receptor agonist ramelteon (Rozerem) could facilitate the discontinuation of long-term zolpidem therapy in adults with chronic insomnia. In this study, participants in the control group received a placebo tablet matching ramelteon while their existing zolpidem therapy was incrementally reduced over a 10-week period. Zolpidem is a nonbenzodiazepine hypnotic of the imidazopyridine class that acts as a selective positive allosteric modulator of the GABA-A receptor, specifically targeting the alpha-1 subunit (BZ1 receptor) to induce sedation. The placebo component is pharmacologically inactive and served to maintain the double-blind nature of the study against the ramelteon treatment arm.

Brand names

Ambien

Other names

Placebo and zolpidemplacebo + zolpidem-Takeda-chronic insomnia