Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced that the U.S. Food and Drug Administration has approved Dayvigo (lemborexant) 5 mg and 10 mg for the treatment of adult patients with sleep-onset insomnia and sleep maintenance insomnia. According to Eisai, the [...]
Health Canada, a federal department responsible for helping Canadians maintain and improve their health, issued a letter to health care professionals in June, warning them about the risk of congenital anomalies when modafinil is used during pregnancy. Modafinil is indicated to improve wakefulness in [...]
The FDA has issued a safety alert warning that serious breathing difficulties may occur in patients with respiratory risk factors who are using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR). These risk factors include the use of opioid pain medicines and other [...]
Today the U.S. Food and Drug Administration (FDA) issued a notice requesting nominations for voting members to serve on the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. The MDAC reviews and evaluates data on the safety [...]
According to a safety announcement and consumer update issued April 30, the U.S. Food and Drug Administration is requiring the addition of a boxed warning to the prescribing information and the patient medication guides for the insomnia medications eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem [...]
