A new insomnia treatment drug Belsomra (suvorexant) that is the first of its kind is approved by the U.S. FDA. Belsomra (suvorexant) tablets are accepted for the treatment of patients with insomnia, which means they have problem in falling and remaining asleep.
The new sleep medication is known as orexin receptor antagonist and it functions by changing the brain chemical orexin action, which benefits in regulating the sleep-wake cycle and also benefits in keeping the people awake.
In order to assist professionals of health care and patients in getting the best dose to treat the sleeplessness of each separate patient, the FDA has accepted Belsomra in four diverse strengths – 5mg, 10mg, 15mg and 20mg. Making use of the lowest effective dosage can decrease the risk of side effects, for example drowsiness in the next morning.
Dosage for the New Insomnia Treatment Drug
Belsomra should be consumed only once in a night, in 30 minutes of getting to bed, and with a minimum of seven hours residual prior to the planned waking time. The entire dose should not surpass 20 mg once every day, the FDA said.
The approval of the drug was founded on the three clinical trials’ findings that comprised more than 500 individuals, said the agency. The outcomes presented that individuals who consumed Belsomra fell asleep faster and remained asleep during the night as compared to those who consumed a placebo.
Belsomra was not matched to other drugs of insomnia, so it is not known if there are variances in effectiveness or safety.
Side Effects from the New Insomnia Treatment Drug
The FDA asked the maker of Belsomra Merck, Sharpe & Dohme Corp. to research on the next-day driving performance in individuals who had consumed the medication. Both women and men had reduced driving skills when they consumed the 20-mg dosage, which means that individuals who consume that maximum dosage should be warned to avoid driving or other actions that need a complete mental attentiveness the subsequent day.
Even the people who consume lower amounts should be alerted about conceivable sleepiness the subsequent day, as the individuals have diverse drugs sensitivities, the FDA noted.