Eisai Co. Ltd. and Purdue Pharma LP said results from multiple clinical studies showed sleep disorder drug lemborexant helped patients go to sleep faster and do better in tests evaluating balance and driving performance.
In a phase 3 study called Sunrise 1, patients given the medicine got to sleep faster than those who took placebo. Those who took lemborexant also slept longer while they were in bed, a metric known as sleep efficiency, compared to those who took placebo.
The study also showed that patients given lemborexant experienced less time awake in the second half of the night after a month of treatment, compared to those who were given insomnia drug zolpidem ER, sold as Ambien by Sanofi.
The late-stage study evaluated the therapy in about 1,000 patients aged 55 years and older.
Meanwhile, in a phase 1 safety study dubbed Study 108, patients taking the drug had better balance in the middle of the night and after waking up compared to those taking zolpidem ER. The trial studied 56 healthy volunteers aged 55 years and older.
The only meaningful side effect experienced by those taking lemborexant in Study 108 was headache.
Another phase 1 study, named Study 106, evaluated residual next-morning effects of the therapy. The study showed that patients also performed better in a driving test the morning after taking the drug before sleeping. The study evaluated 48 healthy adult and elderly volunteers.
The companies hope lemborexant improves patients' ability to sleep through the night, but still allow them to function if they awaken during the night, or when they wake in the morning, said Lynn Kramer, Chief Clinical Officer and Chief Medical Officer of Eisai's Neurology Business Group.
Tokyo-based Eisai and Stamford, Conn.-based Purdue Pharma are also studying lemborexant as treatment for patients with irregular sleep-wake rhythm disorder in patients with Alzheimer's disease dementia.
