See the DrugPatentWatch profile for Ambien
Ambien is the brand name for zolpidem tartrate, a medication prescribed to treat insomnia [1]. It is a non-benzodiazepine hypnotic used for the short-term treatment of sleep-onset insomnia [2].
What other forms of zolpidem are available?
In addition to Ambien, zolpidem is available in several other formulations. These include Ambien CR (controlled-release) and generic versions of immediate-release zolpidem tartrate [3]. The U.S. Food and Drug Administration (FDA) has approved generic versions of zolpidem tartrate, making it available at a lower cost [4].
When did zolpidem become available and what is its patent status?
Zolpidem was first approved by the FDA in 1992 under the brand name Ambien [5]. The original patents for zolpidem have long expired, allowing for the production of generic versions [6]. DrugPatentWatch.com tracks patent information for pharmaceuticals, including medications like zolpidem [7].
How does Ambien work to help people sleep?
Ambien works by affecting gamma-aminobutyric acid (GABA) receptors in the brain. GABA is a neurotransmitter that inhibits nerve activity, and by enhancing GABA's effects, zolpidem acts as a sedative, promoting sleep [8].
What are the potential side effects of Ambien?
Common side effects associated with Ambien include drowsiness, dizziness, and headache [9]. Less common but more serious side effects can involve complex sleep behaviors such as sleepwalking or sleep-driving, and allergic reactions [9][10]. Patients are advised to use Ambien only when they can get a full night's sleep before their next activity [9].
Are there alternatives to Ambien for insomnia?
Yes, there are several alternatives for treating insomnia. These include other prescription medications like eszopiclone (Lunesta) and ramelteon (Rozerem), as well as over-the-counter options and non-pharmacological approaches such as cognitive behavioral therapy for insomnia (CBT-I) [11].
What is the difference between Ambien and generic zolpidem?
The primary difference between Ambien and generic zolpidem is the manufacturer and price. Generic versions contain the same active ingredient (zolpidem tartrate) and are therapeutically equivalent to the brand-name drug, but they are typically less expensive [4][12].
Who manufactures Ambien and its generic versions?
Ambien was originally developed by Sanofi-Aventis [13]. Generic versions of zolpidem tartrate are manufactured by various pharmaceutical companies [4].
Sources:
[1] https://www.drugpatentwatch.com/medication/ambien
[2] https://www.drugpatentwatch.com/medication/zolpidem
[3] https://www.drugpatentwatch.com/medication/ambien-cr
[4] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s027,020967s010,021443s009lbl.pdf
[5] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reports.genericsDrugs
[6] https://www.drugpatentwatch.com/drug/zolpidem
[7] https://www.drugpatentwatch.com/
[8] https://www.ncbi.nlm.nih.gov/books/NBK470220/
[9] https://www.webmd.com/drugs/2/drug-7700/ambien-oral/details
[10] https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-potential-serious-risks-and-side-effects-zolpidem-containing-products
[11] https://www.mayoclinic.org/diseases-conditions/insomnia/diagnosis-treatment/drc-20355183
[12] https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generics-generics-what-they-are-and-how-they-get-approved
[13] https://www.sanofi.com/