Piromelatine (Neu-P11) is a multimodal sleep drug under development by Neurim Pharmaceuticals. It is an agonist at melatonin MT<sub>1</sub>/MT<sub>2</sub> and serotonin 5-HT<sub>1A</sub>/5-HT<sub>1D</sub> receptors. Neurim is conducting a phase II randomized, placebo controlled trial of cognitive and sleep effects in Alzheimer's disease.
Results of a phase II trial on insomnia in 120 adults were announced in 2013, finding piromelatine 20/50 mg improved sleep over 4 weeks vs placebo. Phase 1A/1B studies in 2011, showed safe dose-dependent improvement in sleep. Pre-clinical studies showed antinociceptive antihypertensive and cognitive benefits in rat disease models of pain, hypertension, and Alzheimer's disease.
Antidepressant and anti-anxiety effects were also demonstrated in animal models.