Sunosi (solriamfetol) is a type of medicine called a dopamine- and norepinephrine reuptake inhibitor (DNRI). It was approved by the FDA in 2019 to treat daytime sleepiness caused by narcolepsy (a disorder that causes you to fall asleep at unexpected times) or obstructive sleep apnea (a condition that affects your breathing at night). It is available as a tablet that you can take by mouth.
How Does Sunosi Treat Sleepiness?
People with obstructive sleep apnea (OSA) or narcolepsy can feel very sleepy during the daytime. This medicine helps you feel more awake. It increases the levels of two substances in the brain called norepinephrine and dopamine, but the exact way it works is not known.
This medicine does not treat nighttime breathing problems caused by OSA; it just helps make you feel more awake during the day. If you have OSA, you will need to continue your treatments for nighttime breathing such as continuous positive airway pressure (CPAP).
How Was This Medicine Studied, and What Benefits Were Seen?
Sleepiness caused by narcolepsy
Sunosi was studied in a trial that included more than 200 adults with narcolepsy. They were told to take Sunosi or placebo pills (containing no medicine) once daily for 12 weeks. The dose used in the trial was either 75 milligrams, 150 milligrams, or 300 milligrams. Since the 300-milligram dose is higher than the maximum recommended dose, this article will not focus on those results. The average age of people in the trial was about 36, more than half were females (59.3%), and about 80% were White. After taking the medicine for 12 weeks, people took surveys (called the Epworth Sleepiness Scale). It asked them eight questions to find out how sleepy they felt and assigned a score based on their response. The highest score was 24, which meant they felt very sleepy. They also did a sleep study (called a Maintenance of Wakefulness Test or MWT test) that measured how long they could stay awake during the day in a dark and quiet room. After 12 weeks of treatment, the study reported the following results:
- People who took Sunosi felt less sleepy. They had lower scores on their surveys compared to those who took placebo pills.
- For those who took Sunosi 75 milligrams, their scores were about 2 points lower (out of 24 total points)
- For those who took Sunosi 150 milligrams, their scores were about 4 points lower (out of 24 total points)
People who took Sunosi were able to stay awake longer during their sleep study than those who took placebo pills.
- Those who took Sunosi 75 milligrams stayed awake about 3 minutes longer (this small difference may have been due to chance rather than the medicine)
- Those who took the 150 milligrams of Sunosi daily stayed awake for about 8 minutes longer
Sleepiness caused by obstructive sleep apnea
Sunosi was studied in a trial that included more than 400 people diagnosed with obstructive sleep apnea. They were told to take Sunosi or placebo pills (containing no medicine) once daily for 12 weeks. The dose of Sunosi used in this trial was either 37.5 milligrams, 75 milligrams, 150 milligrams, or 300 milligrams. Since the 300-milligram dose is higher than the maximum recommended dose, this article will not focus on those results. The average age of people in the trial was 55, 37% were female, and the majority (76%) were White. After taking Sunosi for 12 weeks, people took surveys about how sleepy they felt (called the Epworth Sleepiness Scale, described above) and did a sleep study that measured how long they could stay awake during the day in a dark and quiet room (called a Maintenance of Wakefulness test or MWT test). After 12 weeks of treatment, the study reported the following results:
- Those who took Sunosi (regardless of the dose) reported feeling less sleepy compared to those who took placebo pills. Their survey scores were about 2-4 points lower than those who took the placebo, meaning they were less sleepy.
- Those who took Sunosi (regardless of the dose) stayed awake 5-11 minutes longer during their sleep study compared to those who took placebo pills. People who took the higher doses stayed awake longer than those who took lower doses.
Another longer trial was done afterwards that included people who had narcolepsy and obstructive sleep apnea. People took Sunosi for up to 52 weeks in this trial, and Sunosi continued to work in these patients for the duration of the trial.
What Are the Side Effects, and How Can I Prevent or Manage Them?
Increased blood pressure and heart rate
Sunosi can cause your blood pressure and heart rate to increase. This can increase your risk for other serious health issues including stroke, heart attack, or death. Your health care provider will check your blood pressure and heart rate before you start taking this medicine and during treatment. If you have high blood pressure, continue to take your blood pressure medicine unless otherwise directed by your health care provider.
Here are some things you can do to help maintain a healthy blood pressure.
- Eat a healthy diet and limit salt.
- Exercise regularly as directed by your health care provider.
- Maintain a healthy weight.
- Quit smoking.
- Avoid drinking a lot of alcohol.
If your blood pressure or heart rate increases by too much, your health care provider may need to decrease your dose or you may need to stop taking this medicine altogether.
Mental (psychiatric) side effects
Sunosi can cause mental (psychiatric) side effects. It can cause you to feel anxious, irritable, and agitated or cause you to have trouble sleeping. If you have a history of a mental health condition like bipolar disorder or psychosis (losing touch with reality), it could make the symptoms of these conditions worse.
Before you start taking Sunosi, tell your health care provider about your mental health history, especially if you have a history of bipolar disorder or psychosis (losing touch with reality). Make sure to continue your treatment for your mental health conditions as directed by your health care provider.
Contact your health care provider right away if you experience the following mental (psychiatric) side effects. Your health care provider may need to decrease your dose or you may need to stop taking Sunosi altogether.
- You feel anxious, irritable, or agitated. If you feel anxious, it can sometimes help to take time to relax, manage your stress, exercise, or get together with friends.
- You experience psychosis (losing touch with reality). This can start with trouble thinking clearly, suspiciousness of others, or changes in emotions (feeling emotions very strongly or not feeling emotions at all). As it becomes worse, you could have hallucinations where you hear or see things that others do not, delusions where you believe things that do not make sense to others (like you have special powers), or you may stop taking care of yourself.
- You experience symptoms of bipolar disorder. You may have very high energy, experience racing thoughts, take risks that you would not normally (putting yourself in a harmful situation), have impulsive behavior (like buying something expensive without thinking it through), or move constantly. If you already have a diagnosis of bipolar disorder, you can help to keep your condition stable by taking your medicines even when you feel good. Avoid drugs and alcohol, find ways to deal with stress, keep a routine, and find a support system.
- You have trouble sleeping. Sunosi can also cause you to have trouble sleeping at night. Make sure to take it as soon as you wake up in the morning, when you have at least 9 hours before you plan to go back to bed. This is because taking Sunosi later in the day or closer to your planned bedtime can make it harder to sleep at bedtime. Do not take more than your health care provider prescribed for you. It can help to maintain good sleep habits. Keep a consistent sleep routine, avoid electronics before bed, get regular exercise, and avoid caffeine.
These are not all of the possible side effects of Sunosi. Talk with your health care provider if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088.
What Interactions With Foods and Other Medicines Can Happen?
There are several interactions with other medicines to note.
Monoamine oxidase inhibitors (MAOIs). Do not take Sunosi if you take a medicine known as a monoamine oxidase inhibitor (MAOI) or have taken an MAOI in the past 14 days. Taking these medicines together can cause a dangerous increase in your blood pressure, and can lead to a stroke, aortic dissection (torn major artery), heart attack, kidney failure, eye damage, pulmonary edema (fluid buildup in the lungs), and other complications including death.
Medicines that can increase blood pressure or heart rate. Since Sunosi can increase your blood pressure and heart rate, combining it with other medicines that also increase blood pressure or heart rate can be dangerous. Do not take these types of medicine with Sunosi without talking to your health care provider. Always discuss any over-the-counter medicines or supplements with your health care provider or pharmacist before you take them.
Medicines that affect a substance in the brain called dopamine. Since Sunosi increases the levels of dopamine in your brain, taking it with other medicines that also affect dopamine could lead to increased side effects. Do not take these types of medicines with Sunosi without talking to your health care provider.
This is not a complete list of medicines that may interact with Sunosi. Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions with Sunosi or if you need a dosage adjustment.
Is Sunosi Addictive?
Clinical studies have not found Sunosi to cause physical dependence, which is when your body gets used to a medicine or other substance and then “needs” it or you will experience unpleasant withdrawal symptoms.
How Can I Get Sunosi?
Sunosi is a prescription-only medicine that must be prescribed by a health care provider. You can get it at any pharmacy.
There is a free trial available from the manufacturer that may allow you to try Sunosi for a month without any copay. There is also a savings card available from the manufacturer that may allow you to pay as little as $9 per month. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more about the free trial and savings card at www.sunosi.com/free-trial-offer and www.sunosi.com/savings.
For questions about cost, insurance coverage, or any other questions related to Sunosi, call the manufacturer at 866-496-2976.
