• Sunosi is a brand (trade) name for solriamfetol which may be used to treat adults with narcolepsy or obstructive sleep apnea.
• Sunosi (solriamfetol) blocks the reuptake of norepinephrine and dopamine, two neurotransmitters in the brain that have been associated with wakefulness, although experts are not sure if this is the exact way Sunosi works to reduce daytime sleepiness in people with obstructive sleep apnea or narcolepsy.
• Sunosi belongs to the class of medicines known as selective dopamine and norepinephrine reuptake inhibitors (DNRI).

• May be used to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). It is not a substitute for continuous positive airway pressure (CPAP) or other treatments for airway obstruction.
• Starts working within 1 hour.
• Sunosi is not a stimulant, it is called a wake-promoting agent.
• Has not been shown to cause dependence or symptoms of withdrawal on discontinuation, even with abrupt discontinuation.
• Taken once daily upon awakening in the morning. Do not take it within 9 hours of planned bedtime because it can interfere with sleep.
• May be taken with or without food.
• Available as 75mg and 150mg tablets. The 75mg tablets can be cut or broken in half.
• The dosage for narcolepsy is 75mg once daily to start with, which may be increased to 150mg once daily if an improvement is seen and it is well tolerated. The maximum recommended dosage is 150mg daily.
• The dosage for people with OSA should be started at 37.5mg once daily, and then doubled at intervals of at least every 3 days depending on tolerability and if an improvement is seen. The maximum recommended dosage is 150mg daily.
• Recommended dosages do not prolong the QTc interval to any great extent.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Headache, nausea, decreased appetite, anxiety, and difficulty sleeping were the most common side effects reported. Dry mouth, constipation, and palpitations have also been reported.
• Sunosi increases blood pressure and heart rate. The higher the dosage the bigger the increase. This can increase the risk of cardiovascular events, such as a heart attack or stroke. Blood pressure should be controlled before starting Sunosi. Monitor regularly throughout treatment and treat new-onset high blood pressure and any worsening of existing blood pressure. Consider discontinuation of Sunosi if blood pressure cannot be managed.
• Anxiety, insomnia, irritability, and other psychiatric adverse reactions have been reported with Sunosi. Caution when treating people with a history of psychosis or bipolar disorder. Monitor patients for mood changes and consider a dose reduction or discontinuation if needed.
• Does not cure or treat the cause of OSA, or take the place of CPAP or other treatments for OSA. CPAP (or other treatments for OSA) needs to be started at least 1 month before starting Sunosi and continued throughout Sunosi treatment.
• Sunosi is a Schedule IV Controlled Substance in the United States because it contains solriamfetol, which has the potential for abuse. Always store Sunosi in a safe place, out of reach of children, and also protect it from theft and misuse. Dispose of any unused or expired Sunosi via a medication take-back program, or mix with an undesirable substance and throw it away in the household trash.
• Be careful when prescribing to people with a history of alcohol or drug abuse, especially those with a history of stimulant use (such as methylphenidate, amphetamine, or cocaine). Monitor these patients and look for signs of misuse or abuse (such as incrementation of doses and drug-seeking behavior).
• It is not known if Sunosi is safe and effective in children.
• Interacts with several other medications, including some medications used to treat depression. Do not use Sunosi with Monoamine oxidase inhibitors (MAOIs), such as phenelzine (Nardil), selegiline (Emsam), or tranylcypromine (Parnate), or within 14 days of stopping them. May also interact with medications that increase blood pressure, increase heart rate, or increase or decrease levels of dopamine.
• May interfere with sleep if taken too late in the day.
• The dosage of Sunosi needs adjusting in people with kidney disease. Start Sunosi at 37.5mg once a day and increase to a maximum of 75mg once a day after at least 7 days if tolerated and effective for people with eGFR 30-59 mL/min/1.73 m². Keep dosage at 37.5 mg/day for those with eGFR 15-29 mL/min/1.73m². Do not use in people with end-stage renal disease (eGFR <15 mL/min/1.73m²). People with kidney disease may also be at higher risk of blood pressure increases or psychiatric side effects with Sunosi.
• There is no specific reversal agent for Sunosi. Manage overdoses with primarily supportive care, including cardiovascular monitoring.
• Sunosi has not been evaluated properly in pregnant women but toxicity has been reported in animal studies at more than 4 to 5 times the maximum recommended dose, and teratogenicity at 5 and 19 times the recommended dose. Toxicities include adverse effects on fertility, growth, and development in offspring, and teratogenicities included skeletal malformations and decreased fetal weight. Consider the risks versus benefits when using Sunosi in breastfeeding women and monitor for side effects in the offspring such as agitation, insomnia, anorexia, and reduced weight gain. It is unknown if Sunosi distributes in human milk but it does distribute in rat milk.
• Not available as a generic.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Take Sunosi once daily when you first wake up in the morning, either with or without food. Do not take within 9 hours of an intended bedtime as Sunosi may keep you awake.
• Take Sunosi exactly as directed. Do not increase the dosage unless your doctor tells you to.
• Sunosi may cause anxiety, irritability, or insomnia. Tell your doctor if you have any preexisting mood conditions, such as anxiety, psychosis, or bipolar, or if you notice any changes in your mood.
• Sunosi can also increase your blood pressure and pulse rate. See your doctor if you notice your heart beating faster than normal or develop headaches. Get your blood pressure tested regularly.
• Tell your doctor if you have any underlying conditions, such as heart conditions including a history of a heart attack, kidney problems, diabetes, bipolar disorder, anxiety, or have misused alcohol or stimulants in the past. Sunosi may not be suitable for you. Also tell your doctor about any other medications you may take, including prescription medicines (especially MAOIs), supplements, or herbals as some may not be compatible with Sunosi.
• Sunosi will not treat the underlying airway obstruction associated with OSA, so you will need to continue using your nightly CPAP device or other treatment.
• Tell your doctor if you are pregnant, intend to become pregnant or are breastfeeding. Sunosi has not been evaluated properly in pregnant or breastfeeding women. There is a pregnancy registry (1-877-283-6220 or www.SunosiPregnancyRegistry.com) you should enroll in if you inadvertently find yourself pregnant while taking Sunosi. If you are still breastfeeding while receiving Sunosi monitor your infant for agitation, insomnia, poor feeding, or reduced weight gain, and tell your doctor if you notice any of these happening in your baby.
• Sunosi has the potential to be abused or misused. Keep out of sight of others in a safe place because it may be desirable to some drug seekers. Never share your Sunosi with others.
• Because alcohol can make you sleepy, it is best not to drink alcohol while taking Sunosi.

• Studies have investigated the effects of Sunosi in over 900 people with OSA or narcolepsy. The 150mg dose of Sunosi significantly improved wakefulness at 12 weeks.
• There was an 82% improvement in wakefulness in people with OSA compared to 0% with a placebo (an inactive pill).
• An 118% improvement in wakefulness was reported in people with narcolepsy compared to 5% with a placebo.
• Dosages above 150mg do not offer increased effectiveness at improving wakefulness, but are associated with a higher risk of side effects.
• Sunosi has no appreciable binding affinity to dopamine, serotonin, norepinephrine, GABA, adenosine, histamine, orexin, benzodiazepine, muscarinic acetylcholine, or nicotinic acetylcholine receptors.

Medicines that interact with Sunosi may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Sunosi. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Sunosi include:

• asthma medications such as albuterol, bitolterol, formoterol, salmeterol, or terbutaline
• amantadine
• apomorphine
• bromocriptine or cabergoline
• carbidopa
• desvenlafaxine or venlafaxine
• dopamine or dobutamine
• duloxetine
• ephedrine
• herbals, such as ma huang
• hydroxyamphetamine ophthalmic
• ketamine
• levodopa
• decongestants, such as naphazoline nasal or ophthalmic, oxymetazoline nasal/ophthalmic/topical, or phenylephrine nasal/ophthalmic/topical
• norepinephrine
• monoamine oxidase inhibitors (eg, isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine), or SSRIs (eg, fluoxetine, sertraline)
• stimulants, such as amphetamine or dextroamphetamine.

There may be many other medications that interact with Sunosi, but these have not been studied.

Note that this list is not all-inclusive and includes only common medications that may interact with Sunosi. You should refer to the prescribing information for Sunosi for a complete list of interactions.