"Solriamfetol appears to be more effective and safer than the other current medications prescribed for excessive sleepiness based on the evidence," Dr. Roshan Subedi of Tribhuvan University Teaching Hospital in Kathmandu, Nepal, told Reuters Health by email.
EDS, defined as the inability to maintain wakefulness and alertness during the major waking episodes of the day, with sleep occurring unintentionally or at inappropriate times almost daily for at least three months, is a common symptom of narcolepsy and OSA. Solriamfetol was approved by the U.S. Food and Drug Administration for EDS related to narcolepsy and OSA in March 2019.
Dr. Subedi and colleagues evaluated the safety and effectiveness of solriamfetol in their systematic review and meta-analysis of eight randomized controlled trials.
In the five trials that reported it, results on the Maintenance of Wakefulness Test (MWT), a 4x40-minute test, averaged 9.93 minutes longer with solriamfetol treatment than with placebo (95% confidence interval, 8.25 to 11.61), the researchers report in Sleep Medicine.
"In a setting of a 40-minute test, the mean awake time is around 30 minutes among healthy individuals," Dr. Subedi said. "So, we think 9.93 extra minutes of waking during the test will correlate with significant improvement in the daily life of the patient (as suggested by improved PGI-C and CGI-C)."
"Additionally, other available medications for sleepiness showed improvement of up to 5 minutes, which is lower than solriamfetol," he said. "Hypothetically speaking, such extra minutes may improve driving performance and result in higher productivity during the day."
The lowest price on GoodRx for 30 tablets of 150-mg solriamfetol is $659, or about $2.20 per minute gained on the MWT.
Epworth Sleepiness Scale (ESS) scores improved by 4.44 more points with solriamfetol than with placebo (95% CI, -5.50 to -3.38). The minimum clinically important difference in ESS has been estimated at between 2 and 3 points.
Patient Global Impression of Change (PGI-C) scores improved by 40.2% and Clinical Global Impression of Change (CGI-C) scores improved by 36.5% with solriamfetol relative to placebo.
Patients in the solriamfetol groups were 47% more likely than those on placebo to report adverse events and were twice as likely as placebo patients to discontinue the assigned medication.
Adverse events reported more commonly in the solriamfetol group include headache, nausea, decreased appetite, anxiety, nasopharyngitis and insomnia.
Abrupt discontinuation of solriamfetol was not associated with withdrawal-related adverse effects or with rebound hypersomnia.
"We need more large-scale studies comparing solriamfetol directly to other drugs to generate strong conclusions," Dr. Subedi said. "In the future, the drug may be established as a standard of care or a more effective new drug may be available."
The study received no funding and the authors report no conflicts of interest.
By Will Boggs MD
SOURCE: https://bit.ly/3jpQTWP Sleep Medicine, online September 21, 2020.
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