The Food and Drug Administration reviewers announced last Monday that Merck’s sleeping pill Suvorexant was generally efficient in treating insomnia.
In a study conducted in June 2012, with the participation of 2,000 patients and a follow-up study this year, the FDA staff agreed that Suvorexant is effective in putting people to sleep to stay asleep. However, the reviewers were concerned about the safety of the 10mg dosage levels. One of them noted that at a higher dosage could cause daytime drowsiness.
Effects on obese women
FDA also adds that the pill may have different effects, especially on obese women, and 15 milligrams may result in excessive exposure to the active ingredient due to the way their bodies process the drug. The company now proposes two starting doses between 10 to 15 milligrams.
Merck & Company are one of the largest pharmaceutical companies around the world. The company started in 1891 as a part of the German conglomerate Merck KGaA.
How does it work?
The CDC states that the prevalence of sleep disorder is widespread and affects up to one third of the American population. Benign chronic sleeping problems are usually linked to mental disorders, vehicular accidents, cardiovascular diseases, and poor quality of life. Over the counter and prescription sleeping pills sales have reached billions of dollars yearly.
The primary purpose of sleeping pills is to induce and maintains sleep. The side effects are usually mild to potentially harmful like addiction to the drugs and increased grogginess.
Drugs like Ambien, Sonata, and Lunesta are non habit-forming sleeping pills and none of which usually result in next-day impairment.
In August 2012, Bloomberg published an article featuring Merck’s new experimental drug called Suvorexant with a novel approach to curb next-day grogginess. Suvorexant is a dual orexin antagonist receptor, which means it does not induce sleep but turns off wakefulness. Joseph Herring, executive director for clinical neuroscience at Merck states that during the night, orexin levels in the brain drops, and the drug targets those tiny receptors that keep the body awake.
Suvorexant associated with suicidal thinking?
The clinical data on Suvorexant reveals that the drug can cause significant morning impairment, and it has been associated with increased risk of suicidal thinking.
Over the last 12 months there have been eight cases of suicidal thinking among patients taking the pill compared to patients who were given placebo. FDA will ask a panel of outside experts to vote about the drug’s effectiveness and safety.
FDA scrutinizes the safety of each prescription sleeping drug, which includes a popular brand Ambien. Clinical data shows that the products cause morning impairment, which is especially dangerous for those who are driving.
Further studies needed
In light of this new finding, the FDA panel seeks to discuss the safety of various doses of Suvorexant that will include the proposed starting dose of 15 milligrams for seniors and 20 milligrams for non-seniors. Doctors can always increase the dosage to 30 milligrams and 40 milligrams respectively, once the insomnia has been treated.
The panel will consider asking Merck to conduct a study of a 10 milligram dose before FDA approves the drug. The FDA requires beginning prescription of drug dosage by half to women, as they tend to clear away the active ingredients in the drug slower than men can.
Written by: Janet Grace Ortigas