The U.S. Food and Drug Administration (FDA) has approved DAYVIGO™ (lemborexant) in 5 mg and 10 mg for the treatment of insomnia among adult patients with insomnia. Insomnia is a difficult sleeping condition characterized by the inability to sleep or maintain sleep.
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Approval for DAYVIGO comes after two randomized and double-blined Phase 3 studies that evaluated the efficacy of the drug in comparison to the placebo. One study noted results for one month and the other study continued the comparison for six months. Despite good results, FDA encourages DAYVIGO to be placed under the controlled substances and such is currently being evaluated by the U.S. Drug Enforcement Administration (DEA) before being commercially available.
"We believe the approval of DAYVIGO is particularly exciting because it is the first FDA-approved medication to report safety data over a 12-month period along with sleep onset and sleep maintenance efficacy data over a six-month period in a pivotal clinical study," said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai Pharmaceutical. "We look forward to making this new therapeutic option available to the millions of patients who suffer with insomnia."
DAYVIGO was developed by the pharmaceutical drug company, Eisai.
"Insomnia disorder is a chronic condition that has a variety of potential negative impacts and long-term consequences for health and well-being,"2 said Russell Rosenberg, PhD, D.ABSM, a principal investigator in the DAYVIGO clinical studies and former Chairman of the Board of the National Sleep Foundation. "The clinical trials provide evidence that DAYVIGO may improve patients' ability to fall asleep and stay asleep."
In both studies, the most commonly reported side-effects that led to discontinuation was because somnolence and nightmares. In addition, the effects of DAYVIGO at the beginning of treatment were generally the same as the endpoint.
The drug was not associated with rebound insomnia following discontinuation or any withdrawal effects. However, DAYVIGO was associated with dose-dependent worsening effects on attention and memory compared to the placebo.
"DAYVIGO is an important addition to Eisai's rapidly growing neurology portfolio and underscores our leadership in neuroscience," said Ivan Cheung, Chairman and CEO, Eisai Inc. and Global President, Neurology Business Group, Eisai Co., Ltd. "Our commitment to patients and their families drives our relentless pursuit of innovative healthcare solutions."
Source: FDA