Belsomra Could Give Patients New Hope as Treatment for Insomnia
In mid-August, the FDA and Merck announced a new medication approved as an insomnia treatment. Suvorexant is the first drug in its class that’s FDA approved. It is an orexin-receptor antagonist designed to help orexins regulate the sleep-wake cycle.
The FDA has recommended this medication be classified as a Schedule IV controlled substance. The drug will be marketed under the name Belsomra, by the end of the year or early in 2015. Before it can reach the market, the Drug Enforcement Administration, or DEA, must finalize the controlled substance scheduling process.
Suvorexant labeling indicates the medication is for the “initiation or maintenance of sleep” for adults who suffer from insomnia. Narcoleptics should not use this medication, as it is contraindicated. The medication will be available in multiple dose formats, including 5 mg, 10 mg, 15 mg, and 20 mg tablets, packaged in blister packaging with 30 tablets per blister pack. The medication needs to be stored away from light, at room temperature, in the original packaging.
The suvorexant medication guide suggests that the medication should be taken within a half hour before bed, and only when expected to stay in bed for at least seven hours. Patients should not take more than what is prescribed, and should take only the lowest possible dose to achieve the desired result.
The recommended dose is 10 mg, to be taken once a night. If the lower dose is tolerated, but not effective enough, the dose may be increased to 20 mg per night. However, patients should not attempt to increase the dose on their own, without first speaking to their prescribing doctor.
If the patient is receiving concomitant therapy with medication that inhibits the cytochrome P-450 isoenzyme system, they should begin treatment with a 5 mg dose, and increase the dose to no more than 10 mg per night, as directed by the prescribing doctor.
During clinical trials, the most commonly reported adverse effect was feeling drowsy or sleepy. Other reported side effects include: abnormal dreams, headache, cough, upper respiratory infection, and dry mouth. These side effects were more common among women than men. The risk for adverse reactions increases with higher doses, and was more frequently seen in obese adults, particularly women. Patients who have concerns about side effects should speak with their doctor before discontinuing the medication or making dosage adjustments.
Patients who use suvorexant may be at risk for respiratory depression, depression and/or suicidal thoughts, sleep paralysis, and other behaviors like “sleep driving” while using the medication. This is why the medication must only be taken before the patient goes to bed, and only when the patient is able to sleep at least seven hours. Use of this medication may be habit-forming.
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