Doxylamine succinate is an antihistamine commonly used to treat insomnia and, in combination with pyridoxine, nausea and vomiting during pregnancy, often referred to as morning sickness [1][2]. It functions by blocking histamine, a substance in the body that triggers allergy symptoms and can also induce drowsiness [1].
What is Doxylamine Succinate Approved For?
Doxylamine succinate is approved by the U.S. Food and Drug Administration (FDA) for use as a nighttime sleep-aid [1][3]. It is also a component of prescription medications approved for the treatment of nausea and vomiting associated with pregnancy [2].
How Does Doxylamine Succinate Work as a Sleep Aid?
As a first-generation antihistamine, doxylamine succinate inhibits the action of histamine H1 receptors. This antagonism is responsible for its sedative effects, making it useful for inducing sleep [1].
Can Pregnant Women Take Doxylamine?
Yes, doxylamine succinate, typically in combination with pyridoxine (vitamin B6), is approved and widely used to manage nausea and vomiting during pregnancy [2]. This combination is available both by prescription and over-the-counter [4].
What Are the Side Effects of Doxylamine Succinate?
Common side effects of doxylamine succinate include drowsiness, dizziness, dry mouth, blurred vision, and constipation [1]. It can also cause difficulty urinating in some individuals [1].
How Long Does Doxylamine Succinate Stay in Your System?
The half-life of doxylamine succinate, the time it takes for the concentration of the drug in the body to be reduced by half, is typically around 10 to 12 hours [5]. This means its effects can linger, potentially causing daytime drowsiness if not managed appropriately [1].
Are There Alternatives to Doxylamine for Sleep or Morning Sickness?
For insomnia, alternative treatments include cognitive behavioral therapy for insomnia (CBT-I), melatonin, and other prescription sleep medications [6]. For morning sickness, alternatives can range from dietary changes and ginger to other antiemetic medications, depending on severity [4].
When Does the Patent for Doxylamine Succinate Expire?
Doxylamine succinate is a well-established generic medication. Its original patents would have expired many years ago, allowing for its widespread availability as an over-the-counter and generic prescription drug [7].
Who Manufactures Doxylamine Succinate Products?
Numerous pharmaceutical companies manufacture doxylamine succinate in various formulations, including both generic and branded products. It is widely available from major over-the-counter drug brands and generic manufacturers [3][4][7].
Sources:
[1] https://www.drugpatentwatch.com/drug/doxylamine-succinate
[2] https://www.drugpatentwatch.com/drug/diclegis
[3] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reports.generics&table=genericsbydrug&drugname=DOXYLAMINE%20SUCCINATE
[4] https://www.rxlist.com/script/main/mobilearticlereact.jsp?articlekey=234407&name=doxylamine-succinate-and-pyridoxine-hydrochloride-oral
[5] https://www.ncbi.nlm.nih.gov/books/NBK551508/
[6] https://www.nhs.uk/mental-health/conditions/insomnia/treatment/
[7] https://www.drugpatentwatch.com