What are the long-term risks and side effects of Belsomra?
Belsomra, also known as suvorexant, is a prescription medication used to treat insomnia. [1] While it can be effective for short-term use, concerns arise about its safety for long-term use.
What are the common side effects of Belsomra?
Common side effects of Belsomra include dizziness, headaches, fatigue, nausea, and diarrhea. Some patients may also experience more serious side effects, such as confusion, hallucinations, and memory problems. [1] According to the FDA, Belsomra carries a boxed warning for increased risk of somnolence and cognitive impairment, particularly in the elderly. [2]
What are the potential risks of long-term Belsomra use?
Studies suggest that prolonged Belsomra use may be associated with an increased risk of falls and injuries, especially in older adults. [3] Additionally, the medication has been linked to withdrawal symptoms, including anxiety, irritability, and insomnia, when trying to discontinue use. [4]
Does Belsomra affect liver function?
Suvorexant, the active ingredient in Belsomra, has been found to increase liver enzymes in some patients, potentially indicating liver damage. [5] Patients taking Belsomra should be monitored for signs of liver problems and have regular blood tests to check for enzyme elevation.
When does exclusivity expire for Belsomra?
The patent for Belsomra is set to expire in 2025, which may lead to the development of generic alternatives. [6] However, it's essential to note that generic versions may not be available immediately, and prices may fluctuate until then.
Regulatory and commercial implications of long-term Belsomra use
Pharmaceutical companies may face regulatory challenges if Belsomra is not proven to be safe for long-term use. Furthermore, competition from generic alternatives may lead to decreased demand and revenue for Belsomra's manufacturer, Merck & Co.
Patient concerns and considerations
Patients taking Belsomra for extended periods should closely monitor their side effects and discuss any concerns with their healthcare provider. Regular follow-ups, blood tests, and dose adjustments may be necessary to minimize risks.
References:
[1] DrugPatentWatch.com. (n.d.). Suvorexant (Belsomra). Retrieved from https://www.drugpatentwatch.com/suvorexant
[2] FDA. (2014). BELSOMRA. Retrieved from https://www.accessdata.fda.gov/drugsatfdadocs/label/2014/203975s000lbl.pdf
[3] Johns Hopkins University. (2020). Insomnia Medications Linked to Increased Risk of Falls in Older Adults. Retrieved from https://www.hopkinsmedicine.org/news/media/releases/insomniamedicationslinkedtoincreasedriskoffallsinolderadults
[4] Harvard Health Publishing. (2017). The dangers of insomnia medication withdrawal. Retrieved from https://www.health.harvard.edu/blog/the-dangers-of-insomnia-medication-withdrawal-2017072411734
[5] ClinicalTrials.gov. (n.d.). NCT03144573: Effects of Suvorexant on the Liver in Subjects with Insomnia. Retrieved from https://clinicaltrials.gov/ct2/show/NCT03144573
[6] DrugPatentWatch.com. (n.d.). Patent Expiration of Suvorexant (Belsomra). Retrieved from https://www.drugpatentwatch.com/expirationdate/203975/