Effectiveness of Belsomra was studied in three clinical trials totaling more than 500 participants who were given various doses (5mg, 10mg, 15mg, or 20 mg) of the orexin antagonist or a placebo. The results showed that the patients in the Belsomra group fell asleep faster and spent less time awake during the night when compared with individuals taking placebo. Furthermore, the FDA asked Merck, the drug’s manufacturer, to assess next-day driving performance of individuals administered Belsomra. The evaluation showed that impaired driving skills were significant in patients who took the maximum approved dose of 20 milligrams. The most commonly reported side effect among clinical trial participants was drowsiness. Belsomra was not compared with other approved medications indicated for insomnia.
Director of the FDA Office of Drug Evaluation I, Ellis Unger, M.D., commented that recent approval will "assist health care professionals and patients in finding the best dose to treat each individual patient’s sleeplessness.... Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness."
The FDA recommends that Belsomra be taken no more than once a night, within 30 minutes of going to bed, with at least seven hours remaining before the planned wake time. Because Belsomra can be abused and lead to dependence, the Schedule IV drug will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information.
Read the FDA news release about Belsomra here. For information on insomnia and other diagnoses of sleep disorders, see the Psychiatric News articles, "Manual Updates Sleep Disorder Diagnoses" and "Improving Sleep May Benefit Psychiatric Disorders."