Drugs Xagena
The U.S. Food and Drug Administration ( FDA ) has approved Belsomra ( Suvorexant ) tablets for use as needed to treat difficulty in falling and staying asleep ( insomnia ).
Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling of orexin in the brain.
Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long.
Insomnia can cause daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable.
People with insomnia may have trouble with attentiveness, learning, and memory.
The FDA has approved Belsomra in four different strengths: 5, 10, 15, and 20 milligrams.
Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20 mg once daily.
The most commonly reported adverse reaction reported by clinical trial participants taking Belsomra was drowsiness. Medications that treat insomnia can cause next-day drowsiness and impair driving and other activities that require alertness. People can be impaired even when they feel fully awake.
The FDA asked the drug manufacturer to study next-day driving performance in people who had taken Belsomra. The testing has shown impaired driving performance in both male and female participants when the 20 mg strength was taken. Patients using the 20 mg strength should be cautioned against next-day driving or activities requiring full mental alertness. Patients taking lower doses should also be made aware of the potential for next-day driving impairment, because there is individual variation in sensitivity to the drug.
The effectiveness of Belsomra was studied in three clinical trials involving more than 500 participants. In the studies, patients taking the drug fell asleep faster and spent less time awake during the remainder of the night compared to people taking placebo.
Belsomra was not compared to other drugs approved to treat insomnia, so it is not known if there are differences in safety or effectiveness between Belsomra and other insomnia medications.
Like other sleep medicines, there is a risk from Belsomra of sleep-driving and other complex behaviors while not being fully awake, such as preparing and eating food, making phone calls, or having sex. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy. Patients or their families should call the prescribing health care professional if this type of activity occurs. ( Xagena )
Fonte: FDA, 2014
XagenaMedicine_2014
