Dexmedetomidine is a medication that has been around since the late 1990s, but most people are probably unfamiliar with it because it has only been used in the hospital in an intravenous dosage form. Dexmedetomidine works by stimulating the alpha-2 adrenergic receptor. This receptor is found mainly in the central nervous system. Stimulating this receptor produces sedative and pain-relieving effects. BioXcel Therapeutics company has come out with a new dosage form of dexmedetomidine to be used for the treatment of agitation related to schizophrenia or bipolar I or II called Igalmi. This medication should be administered under the supervision of a healthcare provider who can monitor certain factors, like blood pressure and alertness.
Igalmi is a sublingual film, taken by placing it under the tongue or behind the lower lip and allowing it to dissolve. It is the first and only sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults according to the manufacturer’s website. It is meant for short-term treatment only. It has not been proven safe or effective for use for more than 24 hours. Igalmi should not be used in children because it has not been studied for use in children. The film is supplied as either 120mg or 180mg. It should not be chewed or swallowed, just placed under the tongue or behind the lower lip and allowed to dissolve as previously noted. Though they cannot be chewed, the films may be cut in half to provide either 60mg or 90mg of medication. After allowing the film to dissolve under the tongue, you should not eat or drink for at least 15 minutes. If you dissolve the film in the lower lip (also called buccally), you should not eat or drink for at least 60 minutes after.
The specific dose for each person might depend on the severity of symptoms and age. Another factor to consider is liver function. If your liver is not functioning as it should, your healthcare provider may need to start you at a lower dose. After the initial dose of Igalmi, an additional two doses may be administered if agitation persists. Doses should be administered at least two hours apart. The main side effects associated with Igalmi were somnolence, sleepiness, low blood pressure, mouth numbness, dizziness, and a tingling or prickling sensation called paresthesia. Due to the risk of sleepiness, patients should not operate any vehicle or machinery within 8 hours of a dose of Igalmi. There are certain drug interactions to be aware of. Healthcare providers should use caution if the recipient is also taking other medications that can be sedating or other medications that can increase the risk of heart troubles (QT prolongation).
Igalmi will be beneficial in the healthcare setting for treating acute agitation associated with schizophrenia or bipolar I or II disorder. It is the first and only sublingual film for its indication, which could help people with agitation feel more comfortable and help healthcare providers perform their assessments appropriately without the use of other forms of calming medications.
Resources:
1) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215390s000lbl.pdf
2) https://www.igalmihcp.com
