Belsomra could become first-line insomnia therapy, says GlobalData

Insomnia treatment Belsomra (suvorexant) from US pharma giant Merck & Co (NYSE: MRK) has the potential to become a first-line therapy for insomnia following approval by the US Food and Drug Administration last week, although it will need to build physician confidence to encourage uptake, according to an analyst with research and consulting firm GlobalData.

Belsomra was recently approved to treat insomnia at doses of five, 10, 15 and 20 milligrams (mg). Thomas Parker, GlobalData's analyst covering neurology and ophthalmology, said the drug is now expected to address some of the key unmet needs in the insomnia therapeutics market, including the demand for products with improved tolerability.

Dr Parker said: “In the absence of head-to-head clinical trial data, Belsomra’s safety profile is proposed to be superior to that of the nonbenzodiazepines, namely Ambien and Lunesta, which are currently the gold-standard insomnia treatments. Nonbenzodiazepines are associated with various side effects, such as next-day sedation, physical or psychological dependence, headache, nausea and dizziness. In contrast, Merck’s Phase III clinical trial program revealed that Belsomra’s tolerability is proportionate to placebo for the approved doses. Of the total drug-treated patients, 46.5% reported an adverse event, compared to 46.6% of placebo patients.”