Excessive daytime sleepiness (EDS) affects up to 28% of the general population and is most commonly caused by sleep disorders, poor sleep habits, and sedatives. People with EDS may feel drowsy, have trouble staying awake during the day, or complain about a general lack of energy, which can result in compromised job performance or car accidents.
Solriamfetol (Sunosi) is the first dual-acting dopamine and norepinephrine reuptake inhibitor for the treatment of persistent daytime sleepiness in adults. The once-daily prescription medicine is available in 75-mg and 150-mg tablets.
Sunosi isn”t the only wake-promoting drug on the market — modafinil and armodafinil are also approved to treat EDS. According to sleep medicine specialist Atul Malhotra, MD, who spoke with Medscape about the efficacy of Sunosi, there have been no head-to-head trials comparing Sunosi to other wake-promoting drugs, but at least one study suggests it may be more effective at reducing sleepiness.
Here are five things to know about Sunosi.
1. Sunosi improves wakefulness in people with obstructive sleep apnea (OSA) and narcolepsy.
A clinical trial found that people who took Sunosi remained awake longer and experienced a decrease in sleepiness during the day compared to people who received placebo. One 12-week study found that 89.7% of those with OSA who took 150 mg of Sunosi experienced an overall improvement of symptoms at the end of the trial, compared to 49.1% of those who received placebo. Another short-term study found that 78.2% of participants with narcolepsy who underwent treatment with Sunosi 150 mg reported improvements in symptoms after 12 weeks, compared to 39.7% of those who received placebo.
In 2019, Malhotra and colleagues conducted a study of the long-term effects of Sunosi. Their study expanded on previous 6- and 12-week studies that had shown the drug to be effective. The patients in this study had already participated in short-term studies of Sunosi.
Participants were divided into two groups. Those in group A had completed a 12-week narcolepsy or OSA study and had been monitored for 40 weeks. Those in group B had narcolepsy or OSA and had completed a 6-week study of Sunosi. They were monitored for 52 weeks. The Patient and Clinical Global Impression of Change (PGI-C) scale was used to assess the drug’s effectiveness.
After 40 weeks, Malhotra and colleagues found that 89.2% of participants in group A reported an improvement of symptoms on the PGI-C scale. Those patients included 90.4% of people with OSA and 87.1% of those with narcolepsy. In group B, 93.4% of participants reported an improvement of symptoms, including 96.4% of those with OSA and 86.8% of those with narcolepsy.
Although the US Food and Drug Administration (FDA) approved Sunosi in March 2019 only for the treatment of adults with EDS that was associated with OSA or narcolepsy, Malhotra believes that this drug is likely to promote wakefulness in people with various diseases, such as idiopathic hypersomnia or excessive sleepiness.
2. Don’t mistake Sunosi for caffeine in a pill.
Some people might regard Sunosi as caffeine in pill form, owing to its wake-promoting abilities, but there are some differences.
“Caffeine can make people jittery and nervous, and in high doses, it can be problematic for some, as it yields insomnia,” Malhotra said. “Solriamfetol is generally well tolerated with minimal effects.”
Solriamfetol, the active ingredient in Sunosi, is thought to promote wakefulness by increasing levels of dopamine and norepinephrine — chemicals that play a significant role in the sleep-wake cycle — in the brain. This differs from a stimulant, which directly releases monoamines.
Malhotra said Sunosi should not be used as a substitute for sleep. He commented that people should not stay awake all night and use it to stay awake the following day.
The FDA recommends that Sunosi be taken once a day and not within 9 hours of bedtime to avoid sleep interference.
3. Sunosi does not treat underlying sleep disorders.
Although Sunosi is indicated as a treatment of EDS, which is a common symptom of OSA, it does not treat the underlying cause of the disease. Malhotra said that it is important to advise patients with OSA that Sunosi should not replace treatment with continuous positive airway pressure (CPAP). However, he also said that patients are sometimes given both treatments if they experience residual sleepiness after using CPAP.
Furthermore, one study found that the long-term efficacy and safety of Sunosi were similar regardless of whether patients adhered to their primary OSA therapy, and also that it did not affect primary therapy use.
The underlying cause of narcolepsy is not known, but some cases are caused by the lack of orexin, a brain chemical that regulates sleep. According to Malhotra, Sunosi may promote wakefulness in people with narcolepsy, but it is not thought to “replete orexin or fix the hypothalamus in some way.”
4. Sunosi is a controlled substance.
Sunosi is a Schedule IV controlled substance because solriamfetol, the active ingredient in the drug, has the potential for abuse.
A 2018 study published in the Journal of Psychopharmacology compared Sunosi with a placebo and phentermine, a drug used to promote weight loss and is likely to promote wakefulness because it’s a stimulant.
The researchers found that “overall next day drug liking,” a measurement used in studies of drugs’ potential for being abused, was significantly greater with solriamfetol than with placebo or phentermine. They also found that the willingness of participants to take solriamfetol was significantly greater than their willingness to take placebo but was significantly less than with phentermine.
Overall, the researchers concluded that solriamfetol appears to have an abuse potential similar to or lower than that of phentermine. However, it did not cause symptoms of withdrawal in clinical studies.
“Like every clinical situation, therapy needs to be individualized.” Malhotra said. “I have not had a major issue with drug abuse or drug-seeking behavior with solriamfetol to date. However, I always keep in mind the risks and benefits of every treatment I provide.”
5. Be aware of the side effects of Sunosi.
According to their study, Malhotra and his colleagues found that some of the most common side effects of Sunosi include headache, nausea, decreased appetite, and anxiety. In addition, about 5% of participants in this study developed an upper respiratory tract infection.
Serious side effects include increased blood pressure and heart rate, which could increase the risk for heart attack, stroke, insomnia, heart failure, and death, according to the FDA. The FDA also advises that patients who are taking a monoamine oxidase inhibitor or have stopped taking it within 2 weeks should not use the wake-promoting drug.
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