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New Delhi,April 09, 2019 ;
A new drug, solriamfetol (75, 150, or 300 mg) improved wakefulness on the Maintenance of Wakefulness Test (MWT) and reduced excessive sleepiness on the Epworth Sleepiness Scale (ESS) over a 12-week treatment period when compared with placebo in patients with narcolepsy published in the March 2019 issue of Annals of Neurology.
These improvements were observed in the first week of the study itself and were maintained for the 12 weeks of the study indicating that there was no apparent tolerance to the drug over the study period.
Solriamfetol showed dose‐dependent efficacy that was significantly superior to placebo on both coprimary endpoints at the 150 and 300 mg doses. Solriamfetol 75 mg dose showed greater improvement than placebo on the ESS but not on the MWT.
What is it? Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor with wake-promoting effects.
Side effects: Headache, nausea, loss of appetite, nasopharyngitis, dry mouth and anxiety
Regulatory status: Solriamfetol has been FDA approved to treat excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea (OSA). Approved doses are 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for patients with OSA. It is to be administered once-daily.
The author of this article is Dr KK Aggarwal, Padma Shri Awardee
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