DEC 23, 2019 8:40 AM PST

Novel Drug for Treating Insomnia

WRITTEN BY: Nouran Amin

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.

Learn more about insomnia:

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

About the Author
  • Nouran is a scientist, educator, and life-long learner with a passion for making science more communicable. When not busy in the lab isolating blood macrophages, she enjoys writing on various STEM topics.
You May Also Like
MAR 02, 2021
Immunology
Another Trick up Tumors' Sleeves Exposed
MAR 02, 2021
Another Trick up Tumors' Sleeves Exposed
Tumors have sneaky strategies for establishing themselves within healthy tissues, flourishing in plain sight of circulat ...
MAR 01, 2021
Microbiology
New Therapeutic Potential for a 'Miracle Poison'
MAR 01, 2021
New Therapeutic Potential for a 'Miracle Poison'
Most people know botulism as a nasty disease and botox as a wrinkle reducer that may cause a 'frozen' look if it's overu ...
MAR 18, 2021
Drug Discovery & Development
New Cancer Immunotherapy Targets Genetic Alteration in All Cancers
MAR 18, 2021
New Cancer Immunotherapy Targets Genetic Alteration in All Cancers
Researchers have developed a prototype for a new kind of cancer immunotherapy. The therapy uses engineered T-cells to ta ...
MAR 05, 2021
Drug Discovery & Development
Personalized Treatment for Sickle Cell Disease
MAR 05, 2021
Personalized Treatment for Sickle Cell Disease
Globally, the most prevalent inherited blood disease is sickle cell which affects 70,000 to 100,000 Americans. Despite s ...
APR 03, 2021
Drug Discovery & Development
Why Are Some Cancer Therapeutics Ineffective?
APR 03, 2021
Why Are Some Cancer Therapeutics Ineffective?
Why don’t some cancer therapeutics not work in humans when they were successful in mice? The answer to this questi ...
MAY 04, 2021
Cell & Molecular Biology
A Potential Weakness in SARS-CoV-2 is Caught on Video
MAY 04, 2021
A Potential Weakness in SARS-CoV-2 is Caught on Video
You can see the spike protein of the virus in action in this video.
Loading Comments...