|Other names||SKL-N05, ADX-N05, ARL-N05, YKP10A, R228060, and JZP-110; (R)-2-amino-3-phenylpropylcarbamate hydrochloride|
|Drug class||Norepinephrine–dopamine reuptake inhibitors|
|Elimination half-life||~7.1 hours|
|Excretion||Urine (95% unchanged)|
|Chemical and physical data|
|Molar mass||194.234 g·mol−1|
|3D model (JSmol)|
Solriamfetol, sold under the brand name Sunosi, is a medication used for the treatment of excessive sleepiness associated with narcolepsy and sleep apnea. It is derived from d-phenylalanine and its chemical name is (R)-2-amino-3-phenylpropylcarbamate hydrochloride. It is a norepinephrine–dopamine reuptake inhibitor (NDRI). Common side effects include headache, nausea, anxiety, and trouble sleeping.
Solriamfetol is a norepinephrine–dopamine reuptake inhibitor (NDRI). It binds to the dopamine transporter and the norepinephrine transporter with affinities (Ki) of 14.2 μM and 3.7 μM, respectively). It inhibits the reuptake of dopamine and norepinephrine with IC50 values of 2.9 μM and 4.4 μM, respectively. It has weak affinity for the serotonin transporter (Ki = 81.5 μM) and does not appreciably inhibit serotonin reuptake (IC50 > 100 μM). Solriamfetol has no appreciable affinity for a variety of other targets, including the dopamine, serotonin, adrenergic, GABA, adenosine, histamine, orexin, benzodiazepine, and acetylcholine receptors.
The drug was discovered by a subsidiary of SK Group, which licensed rights outside of eleven countries in Asia to Aerial Pharma in 2011. Aerial ran two Phase II trials of the drug in narcolepsy before selling the license to solriamfetol to Jazz in 2014; Jazz Pharmaceuticals paid Aerial $125 million up front and will pay Aerial and SK up to $272 million in milestone payments, and will pay double-digit royalties to SK.
The U.S. Food and Drug Administration (FDA) approved solriamfetol based primarily on evidence from five clinical trials (Trial 1/NCT02348593, Trial 2/NCT02348606, Trial 3/NCT02348619, Trial 4/NCT02348632, Trial 5 NCT01681121) of 622 patients with narcolepsy or obstructive sleep apnea (OSA). The trials were conducted in Canada, Europe, and the United States.
Solriamfetol was approved for medical use in the European Union in January 2020.
Society and culture
During development it has been called SKL-N05, ADX-N05, ARL-N05, and JZP-110.
In the United States, solriamfetol is a Schedule IV controlled substance, meaning that it has an accepted medical use and a low potential for abuse, but that abuse may lead to physical or psychological dependence. A prescription is required, and can only be refilled up to five times in a six-month period. In countries of the European Union, a prescription is required.
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- "Drug Approval Package: Sunosi". U.S. Food and Drug Administration (FDA). 29 April 2019. Retrieved 24 November 2019. This article incorporates text from this source, which is in the public domain.
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- 21 U.S.C. § 812 – Schedules of controlled substances
- "Manuals – Practitioner's Manual – SECTION V". Retrieved 2014-01-07