New drugs for insomnia! The eludant of ego receptor serombia is available in the United States!
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Last Update: 2020-06-17
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Source: Internet
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Author: User
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, June 04, 2020 /
PRNewswire/ -- Eisai, a Japanese pharmaceutical company, recently announced the launch of the new insomnia drug Dayvigo (lerexmboant) CIV in the U.Smarket, which comes in two sizes (5mg and 10mg tablets) for the treatment of adult insomnia, a sleep arousal disorder characterized by the difficulty of sleeping and sleeping although adequateIt is estimated that about 30 per cent of adults worldwide have symptoms of insomnia, many of which last for months to yearsDayvigo is aofsmall molecule compounds found and developed inside the substrateIn the United States, Dayvigo was approved by theFDAin December 2019 for the treatment of insomnia in adultsIn April, the U.SDrug Enforcement Administration (DEA) listed Dayvigo as a Schedule IV controlled substanceAccording to Schedule IV, patients with a history of abuse or addiction with alcohol or other drugs may have an increased risk of abuse and addiction in Dayvigo and should be carefully trackedDayvigo's active drug ingredient is lemborexant, an appetite receptor antagonist that suppresses appetite signals by competing with appetite receptors (OX1R and OX2R)Appetite is a chemical naturally produced by the hypothalamus that is involved in sleep and wakefulnessthe mechanism of lemborexant's role in the treatment of insomnia is thought to be antagonistic through appetite receptors Appetite neuropeptide signaling systems play a role in awakening Blocking wakelpromotes the combination of neuropeptide appetite A and appetite b in the appetite receptors OX1R and OX2R, which are thought to inhibit wake-up drive signals Lemborexant can be combined with the appetite receptors OX1R and OX2R, which act as a competitive antagonist (IC50 values of 6.1nM and 2.6mM, respectively) and have a stronger inhibitory effect on OX2R estimates that insomnia affects one in three adults But because safety is a big problem with sleep drugs, the new treatment faces a difficult process in getting doctors and patients to approve it Earlier this year, the FDA issued a black-frame warning on a number of insomnia drugs such as Lunesta, Sonata and Ambien, amid reports of deaths and injuries from dangerous activities such as sleepwalking and sleep driving among patients taking them there are still significant unmet medical needs in the treatment of insomnia due to efficacy and safety issues Dayvigo is a product that solves both sleep problems and sleep maintenance problems, and the mechanism of the drug does not impair morning posture stability and cognitive ability Dayvigo's launch will provide an important new treatment option for the group of insomniacs lemborexant Molecular Structure (Photo: Wikipedia) Dayvigo was approved by the U.S FDA based on data from the Lemborexant Insomnia Clinical Development Program, which included two critical Phase III clinical studies of SUNRISE-1 (304 studies) and SUNRISE-2 (303 studies) for approximately 2,000 patients THE SUNRISE-1 STUDY, CONDUCTED IN 1006 PATIENTS AGED 55 YEARS (45% OF PATIENTS AGED 65 YEARS OLD) AND SLEEPLESS AT NIGHT, ASSESSED THE EFFICACY AND SAFETY OF LEMBOREXANT RELATIVE TO PLACEBO AND THE POSITIVE CONTROL DRUG LEOXANOTOL, AND SHOWED THAT THE STUDY REACHED THE PRIMARY AND SECONDARY ENDPOINTS, WITH THE MOST COMMON ADVERSE EVENTS REPORTED BY THE LEMBOREXANT TREATMENT GROUP BEING HEADACHES AND DROWSINESS The SUNRISE-2 study, conducted in 949 adults (18-88 years of age) with insomnia, assessed the efficacy and safety of lemborexant relative to placebo, and the study also reached primary and critical secondary endpoints The most common adverse events reported by the lemborexant treatment group were drowsiness, nasopharyngitis, headache and influenza In addition to these key trials, , Aishi has conducted a number of studies to further evaluate Dayvigo's safety, including studies of lemborexant's ability to awaken sound, the stability of the next day's posture or memory, and its effects on driving performance the next morning The data showed that although there was no significant difference in the ability of lemborexant and placebo to awaken sound, lemborexant had a worsening dose dependence in attention and memory compared to placebo In addition, there was no significant difference between lemborexant and placebo in terms of posture stability or memory on the next day Although the 5 mg and 10 mg doses of lemborexant did not cause statistically significant damage to the driving performance of adults or older subjects the next morning (compared to placebo), driving performance was impaired in some subjects taking a 10 mg dose of lemborexant (BioValleyBioon.com) original source: EISAI LAUNCHES NEW INSOMNIA DRUG DAYVIGO™ (LEMBOREXANT) CIV IN THE UNITED STATES AS A TREATMENT OPTION SFOR ADULTS WITH
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