Sunosi Approved For Excessive Daytime Sleepiness In Adults
Solriamfetol is approved for adult patients suffering from the effects of narcolepsy and OSA.
Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat excessive daytime sleepiness in adults.
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The once-daily oral tablet is to be taken upon awakening and should be avoided within 9 hours of planned bedtime to avoid interference with sleep. Though solriamfetol is indicated for patients suffering from fatigue due to narcolepsy or obstructive sleep apnea , it is not intended to treat underlying airway obstruction in OSA. It is recommended that the patient’s airway is treated with continuous positive airway pressure for at least one month prior to beginning to take solriamfetol. Patients should also maintain treatment for OSA while taking solriamfetol.
Page 2: Prescribing Information
Indications: adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
Dosage:
- Once daily upon awakening, avoid use within 9 hours of intended bedtime
- Narcolepsy starting dose: 75 mg once daily
- OSA starting dose: 37.5 mg once daily
- Doses may be increased in three-day intervals, maximum being 150 mg daily
- For patients with renal impairment:
- Starting dose: 37.5 mg once daily
- Maximum: 75 mg once daily after 7 days
- Severe impairment: 37.5 mg once daily
- Not recommended for patients with end stage renal disease
How Is Chronic Fatigue Syndrome Diagnosed
CFS can be difficult to diagnose. There is no specific test for CFS, and other illnesses can cause similar symptoms. Your health care provider has to rule out other diseases before making a diagnosis of CFS. He or she will do a thorough medical exam, including:
- Asking about your medical history and your family’s medical history
- Asking about your current illness, including your symptoms. Your doctor will want to know how often you have symptoms, how bad they are, how long they have lasted, and how they affect your life.
- A thorough physical and mental status exam
- Blood, urine, or other tests
Memory And Concentration Problems
Memory aids, like organizers and calendars, can help with memory problems. For people with ME/CFS who have concentration problems, some doctors have prescribed stimulant medications, like those typically used to treat Attention-Deficit / Hyperactivity Disorder . While stimulants might help improve concentration for some patients with ME/CFS, they might lead to the push-and-crash cycle and worsen symptoms. Push-and-crash cycles are when someone with ME/CFS is having a good day and tries to push to do more than they would normally attempt .
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Case Presentation: Case 1
A white British female, now aged 63 , developed viral meningitis with accompanying vomiting leading to severe dehydration in 1988 when aged 33. She had previously been well and working as a general practitioner. Viral meningitis was diagnosed by lumbar puncture and again 6 weeks later on repeat hospital admission. She remained extremely unwell, being bed bound and unable to self-care, with profound weakness and fatigue, general malaise, light and sound sensitivity, repeated dizziness causing collapse, persistent anxiety and widespread pain. Although she improved slowly over the next 5 years, she was only able to return to work on a limited basis, still suffering headaches, fatigue, postexertional malaise and frequent migraine attacks characterised by vomiting and visual disturbances.
Following gastroenteritis in 1999, she again became bed bound and unable to self-care. Improvement was slower than the initial illness, and after 5 years she was still dependent on carers and used a motorised wheelchair when outside. She developed multiple food intolerances, shown on blood tests and confirmed by repeated withdrawals and reintroductions of intolerant foods. She showed a more dramatic response to wheat, even small amounts, characterised by nausea, severe headache, rapid heart beat and collapse within 10min of consumption, followed by a week of reduced energy and absolute constipation.
Misuse Withdrawal And Dependence
Sunosi is a Schedule IV controlled substance, which means it has some risk of misuse. However, this risk is considered to be less than the risk with stimulant medications such as dextroamphetamine/amphetamine .
In clinical studies, people who took Sunosi for 6 months and then abruptly discontinued the drug did not exhibit signs or symptoms of withdrawal or dependence.
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Sunosi And Other Medications
Below are lists of medications that can interact with Sunosi. These lists do not contain all of the drugs that may interact with Sunosi.
Before taking Sunosi, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Sunosi and monoamine oxidase inhibitors
Taking Sunosi with monoamine oxidase inhibitors could cause dangerous side effects. MAOIs are a group of drugs that are typically used to treat depression. Examples of MAOIs include:
- tranylcypromine
Specifically, you shouldnt take Sunosi with an MAOI or within 14 days of stopping an MAOI. Taking these medications together can cause serious side effects due to a potential severe increase in blood pressure. For example, these side effects may include:
If youre taking an MAOI or youve recently stopped taking an MAOI, let your doctor know right away. Theyll recommend when its safe for you to start taking Sunosi.
Sunosi and drugs that increase blood pressure or heart rate
Examples of drugs that can cause increased blood pressure or heart rate include:
- extended-release ropinirole
What Is Chronic Fatigue Syndrome
Chronic fatigue syndrome is a medical condition that causes severe fatigue, sleep problems, and difficulty concentrating. It is also called myalgic encephalomyelitis . There is no known cause and the condition is long-term.
If you have ME/CFS, your symptoms may sometimes be so severe that you are unable to get out of bed. At other times, you may feel fine.
ME/CFS is most common in people between the ages of 40 and 60. There is no cure for the condition, but treatment can help you manage your symptoms.
After ruling out other potential medical conditions, your healthcare provider can diagnose chronic fatigue syndrome based on your symptoms and medical history.
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What Other Drugs Could Interact With This Medication
There may be an interaction between solriamfetol and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist.Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter , and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sunosi
Can Sunosi Be Used To Treat Insomnia
No, Sunosi isnt approved to treat insomnia. With insomnia, you have trouble falling asleep or staying asleep.
Instead, Sunosi is used to treat excessive daytime sleepiness . Its approved for this use in adults with either narcolepsy or obstructive sleep apnea . People with narcolepsy or OSA have abnormal sleep patterns and can feel extremely tired during waking hours.
Its important to note that Sunosi may cause insomnia as a side effect in some people. For more information on possible side effects of Sunosi, see the Sunosi side effects section above.
If you have trouble sleeping, talk with your doctor about ways to help improve your sleep.
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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.
Can I Take Sunosi If Im Also Using Cpap
Yes, you can. Keep in mind that while Sunosi does improve wakefulness in people with obstructive sleep apnea , the drug doesnt treat OSA itself. So, its important that if youre using continuous positive airway pressure for OSA, you keep using it while youre taking Sunosi.
In fact, if you have OSA, you should use CPAP or another OSA treatment for at least 1 month before starting Sunosi.
If you have questions about using CPAP while youre taking Sunosi, talk with your doctor.
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Sunosi Improves Wakefulness In People With Obstructive Sleep Apnea 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 scale was used to assess the drug’s effectiveness.
How Should I Take Sunosi
Take Sunosi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Sunosi is usually taken once daily when you wake up.
You may take Sunosi with or without food.
You may need to swallow a tablet whole or split it in half. Follow your doctor’s instructions very carefully.
Carefully follow your doctor’s instructions about when to increase your dose. Taking more solriamfetol than prescribed will not make it more effective and may result in serious side effects.
Your blood pressure and heart rate will need to be checked often.
Solriamfetol may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Do not change your dose or stop taking Sunosi without your doctor’s advice.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover Sunosi. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, follow disposal instructions in the Medication Guide provided with your medicine.
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Case Presentation: Case 3
A white British male sustained a head injury when 7 years old and was diagnosed with glandular fever when 10 years old. He developed severe tonsillitis in 1996 when 14 years old. His symptoms gradually worsened and he became bedridden and unable to self-care, suffering profound fatigue, headaches, excessive day and night sleeping and light and sound sensitivity. He was diagnosed with chronic fatigue syndrome by a hospital paediatrician in 1997. He gradually improved over the next 3 years with increased energy. By his mid-20s, he was able to work full time although with persistent tiredness and recurrent infections. He improved further by practising pacing, listening to body symptoms to control his activity and by changing jobs to one with flexible working hours, which he continues to this date. He continued to experience difficulty sleeping and recurrent colds, at least four per year, accompanied by energy dips and subsequent depression. He was diagnosed with nasal polyps, sinusitis and seasonal allergic rhinitis.
Dosage For Excessive Daytime Sleepiness
The usual starting dosage of Sunosi for excessive daytime sleepiness varies depending on the conditions cause. Below, we describe the typical dosage of Sunosi for EDS thats due to either narcolepsy or obstructive sleep apnea .
For either condition, the maximum daily dose of Sunosi is 150 mg.
Dosage for EDS due to narcolepsy
The typical starting dosage of Sunosi for EDS thats due to narcolepsy is 75 mg once daily. Depending on how well your body tolerates the drug, your doctor may increase your daily dose at least every 3 days. Your dosage can be increased until the maximum recommended daily dose of 150 mg has been reached.
Dosage for EDS due to obstructive sleep apnea
The usual starting dosage of Sunosi for EDS thats due to OSA is 37.5 mg once daily. Depending on how well your body tolerates the drug, your doctor may increase your daily dose at least every 3 days. Your dosage can be increased until the maximum recommended daily dose of 150 mg has been reached.
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Can Sunosi Be Crushed Split Or Chewed
Sunosi comes as a scored tablet that can be split in half at the score line. If your doctor recommends it, you can split Sunosi tablets in half before taking your dose. In this case, your doctor or pharmacist can show you how to properly split the tablets.
However, Sunosi tablets shouldnt be crushed or chewed. If youre having trouble swallowing these tablets, talk with your doctor or pharmacist.
Sunosi Can Help You Stay Awake For Up To 9 Hours*
Once-daily SUNOSI is a medication called solriamfetol, which is a wake-promoting agent. SUNOSI is not a stimulant medication.
SUNOSI does not treat the cause of obstructive sleep apnea or take the place of your CPAP.
*In clinical studies at 12 weeks. 75 mg dose did not show improvement across 9 hours in narcolepsy.
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Do not take SUNOSI if you are taking, or have stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor .
Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:
- have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol.
- have had a heart attack or a stroke.
- have a history of mental health problems , or of drug or alcohol abuse or addiction.
- are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
- SUNOSI does not treat the underlying cause of obstructive sleep apnea and does not take the place of any device prescribed for obstructive sleep apnea, such as a continuous positive airway pressure machine. It is important that you continue to use these treatments as prescribed by your healthcare provider.
The most common side effects of SUNOSI include:
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Is Sunosi A Controlled Substance
Yes, Sunosi is a controlled substance. Controlled substances are drugs that are regulated by the federal government. This is because their use may lead to misuse or addiction in some people.
Controlled substances are assigned schedule numbers ranging from Schedule I to Schedule V. Drugs with a lower schedule number are more likely to lead to misuse than are drugs with a higher schedule number. Sunosi is a Schedule IV controlled substance.
Although Sunosi acts like a stimulant by helping you stay awake, this drug isnt classified as a stimulant drug. This is because Sunosi works in a different way than stimulants do. Its thought that Sunosi has a lower risk of misuse and dependence than stimulant medications have.
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 Psychopharmacologycompared 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.”
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