According to Fox News, the U.S. Food and Drug Administration (FDA) has approved a new insomnia drug made by Merck & Co.
It should be noted from the start that insomnia is much more serious than the sleep disturbances that many people have. To be diagnosed with insomnia, you must have at least six months of chronic sleep loss which have created a disturbance in your ability to function at home, work, or in relationships. In fact, several studies indicate that insomnia can lead to many other health challenges, including physical and psychological illness. At the same time, it is a sleep disorder that can develop as a result of other illnesses.
However, for those who have been diagnosed with insomnia, there might be a solution. The approved drug, expected to be called Belsomra, is a sedative that blocks chemicals in the brain called orexins that keep people awake.
However, the drug comes with some side effects that are very important to be aware of, particularly next-day sleepiness and impaired driving. Because of this risky side effect, the FDA asked Merck to study the next-day driving performance of those who took the drug and who experienced drowsiness the next-day.
Despite the fact that the testing did in fact show impaired driving in patients who took 20 milligrams of the drug, the FDA went ahead with approving Belsomra. However, they recommended no more than one pill per night and the dose should not exceed 20 milligrams. They approved the drug in 5, 10, 15 and 20 milligram doses, and issued a warning, “Patients should be cautioned against next-day driving or activities requiring full mental alertness.”
Nonetheless, anyone taking the drug should know about the potential for next-day driving impairment. People will respond differently to different drugs, and should start with a low dose to avoid side effects.
Belsomra, known generically as Suvorexant, is expected to be available in late 2014 or early 2015. However, the Drug Enforcement Administration (DEA) has yet to make its final decision on the scheduling of the drug. Along these lines, the DEA has proposed that the drug be categorized as a Schedule IV in terms of its potential for addiction and abuse. The categorizations for drugs include Schedule 1 drugs, which have the greatest potential for abuse through Schedule V drugs, which have the least potential for abuse.
Although, Merck originally suggested that adults should start with 20 milligrams and increase to 40 milligrams if needed, the FDA found little evidence revealing the drug was more effective at higher doses. In fact, they found that at higher doses the drug was less safe. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness,” said Dr. Ellis Unger, an FDA representative.
Merck changed their original suggestion to recommending 10 milligrams of Belsomra within 30 minutes of going to bed, and ensuring at least seven hours before a patient needs to wake up. The drug is most effective for those who have difficulty getting to sleep and staying asleep.
However, it’s also important to keep in mind that insomnia may be related to other medical and/or psychological conditions, and so medication alone may not always be helpful. For this reason, research indicates that psychotherapy is becoming an effective tool for healing insomnia, especially for those who experience depression and anxiety alongside their inability to sleep.
The National Institute of Mental Health is exploring the treatment of psychotherapy for insomnia that is inexpensive, brief, and solution-oriented. This form of treatment is not currently a standard treatment method for the sleep disorder. However, studies show that using both medication as well as psychotherapy can lead to full recovery in about 40% of patients, which is a significant treatment outcome.