75 mg 150 mg film-coated tablets
solriamfetol
What Sunosi is and what it is used for
Sunosi contains the active substance solriamfetol. Solriamfetol increases the amount of the natural substances dopamine and norepinephrine in the brain. Sunosi helps you stay awake and less sleepy.
It is used
- to adults with narcolepsy, a condition that makes you feel very sleepy at any time, suddenly and unexpectedly. Some patients with narcolepsy also have symptoms of cataplexy (when the muscles become weaker in connection with emotions such as anger, fear, laughter, or surprise. which Can sometimes lead to collapse).
- to increase alertness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnea (OSA) whose EDS has not been adequately treated with primary OSA treatment, such as continuous positive airway pressure (CPAP).
What you need to know before you take Sunosi
Do not take Sunosi if you
- are allergic to solriamfetol or any of the other ingredients of this medicine (listed in section 6)
- have had a heart attack in the past year
- have serious heart problems, e.g. new chest pain or chest pain that lasts longer or is more severe than usual, high blood pressure that cannot be controlled with medicine, severely irregular heartbeat, or other serious heart problems
- are taking a type of medicine called a monoamine oxidase inhibitor ( MAO inhibitor ) for depression or Parkinson’s disease, or have taken MAO inhibitors in the last 14 days.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sunosi if you have or have had
- mental health problems, such as psychosis (disturbed perception of reality) and severe mood swings ( bipolar disorder )
- heart problems, heart attack, or stroke
- high blood pressure
- alcoholism or any drug or drug abuse or dependence
- an eye disease called narrow-angle glaucoma.
Tell your doctor or pharmacist before starting treatment if any of the above applies to you. Sonos may make some of these problems worse. The doctor will do checks to see how the medicine affects you.
Sonos does not replace your usual OSA treatment, e.g. CPAP. You should continue that treatment while taking Sunosi.
Children and young people
Sonos is not recommended for children and adolescents under 18 years of age. Safety and efficacy in this age group are not yet known.
Other medicines and Sunosi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not retake Sunosi
- you are taking a medicine called a monoamine oxidase inhibitor ( MAO inhibitor ) for depression or Parkinson’s disease, or have taken MAO inhibitors in the last 14 days. MAO inhibitors together with Sunosi can raise blood pressure et.
Talk to your doctor or pharmacist if you are taking medicines that can increase blood pressure or pulse (heart rate), or if you are taking dopaminergic substances (eg pramipexole, levodopa, or methylphenidate) used to treat Parkinson’s disease, depression, restless legs syndrome (restless legs) and ADHD.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Sonos should not be used during pregnancy or in women of childbearing potential who are not using effective contraception.
Do not take Sunosi if you are breastfeeding. You and your doctor must decide whether to stop breastfeeding or to stop or withhold treatment with Sunosi after considering the benefit of breastfeeding for you and your baby and the benefit of treatment for you.
Driving ability and use of machinery
You may feel dizzy or have difficulty concentrating, so take special care when driving any vehicle or using machinery.
Talk to your doctor or pharmacist if you are not sure how the underlying disease or this medicine affects you when it comes to activities that require close attention, e.g. driving or using machines
- at the beginning of treatment
- if your dose changes.
How to take Sunosi
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much Sunosi should you take?
The doctor will tell you what dose of Sunosi you should take.
- Treatment for narcolepsy normally starts with 75 mg once daily, to be taken in the morning when you wake up. Some patients may need a starting dose of 150 mg. The doctor will tell you if this applies to you. The doctor may give you a lower dose of 37.5 mg. You get this dose by dividing a 75 mg tablet. The tablet should be split in the score.
- Treatment for OSA usually starts with 37.5 mg once daily, to be taken in the morning when you wake up. You get this dose by dividing a 75 mg tablet. The tablet should be split in the score.
- After at least 3 days of treatment, the doctor can increase your daily dose to the dose that is most suitable for you.
The recommended maximum dose of Sunosi is 150 mg daily.
Elderly (over 65 years)
Take the usual dose once unless you have kidney problems (see below “Patients with kidney problems”).
Patients with kidney problems
If you have kidney problems, your doctor may need to change your dose.
How to take Sunosi
- Sonos should be swallowed.
- Take Sunosi by mouth in the morning when you wake up.
- You can take Sunosi with food or between meals.
How long take Sunosi
Continue taking Sunosi for as long as your doctor has prescribed.
If you have taken too much Sunosi
The following symptoms were seen when a patient received 900 mg of Sunosi (6 times the highest daily dose): uncontrollable movements ( tardive dyskinesia ) and a feeling of restlessness and difficulty staying still ( akathisia ). The symptoms disappeared when treatment with Sunosi was discontinued.
Contact a doctor or the nearest emergency department immediately for advice. Take this leaflet and any tablets you have left with you.
If you forget to take Sunosi
If you forget to take the medicine at the usual time, you can still take it if it is more than 9 hours until bedtime. Do not take a double dose to make up for a missed dose.
If you stop taking Sunosi
Talk to your doctor before you stop taking Sunosi.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people)
- headache.
Common side effects (may affect up to 1 in 10 people)
- anxiety, difficulty sleeping, irritability, dizziness, nervousness, profuse sweating
- fast or irregular pulse, so-called palpitations, discomfort in the chest
- high blood pressure
- nausea, diarrhea, stomach pain, constipation, vomiting
- cough, teeth grinding/clenching, dry mouth
- decreased appetite.
Uncommon side effects (may affect up to 1 in 100 people)
- agitation, restlessness, concentration difficulties, tremors
- an increased heart rate that is much higher than normal
- shortness of breath
- pains in the chest
- thirst
- weight loss.
Skin rash, hives, and itching have also been reported.
How to store Sunosi
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and can/blister after “EXP”. The expiration date is the last day of the specified month.
Blister cards: No special storage instructions.
Cans: After opening, they should be used within 4 months. Seal the jar well. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is solriamfetol.
SunOS 75 mg film-coated tablets
Each tablet contains solriamfetol hydrochloride equivalent to 75 mg solriamfetol.
SunOS 150 mg film-coated tablets
Each tablet contains solriamfetol hydrochloride equivalent to 150 mg solriamfetol.
Other ingredients are:
Tablet core: hydroxypropyl cellulose, magnesium stearate
Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172).
Appearance and package sizes of the medicine
Film-coated tablet
SunOS 75 mg film-coated tablets
Yellow to dark yellow/orange oblong tablet with “75” debossed on one side and scored on the other side. The tablet can be divided into two equal doses.
SunOS 150 mg film-coated tablets
Yellow oblong tablet with “150” embossed on one side.
Sonos is available in blister packs of 7 x 1 film-coated tablet in perforated single-dose blisters of PVC/PCTFE/aluminum, 28 or 56 film-coated tablets, and in cans of 30 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Jazz Pharmaceuticals Ireland Ltd
5 th Floor
Waterloo Exchange
Waterloo Road
Dublin
D04 E5W7
Ireland
Phone: +353 1 968 1631
(local telephone number within Ireland)
(outside the Republic of Ireland international call charges may apply)
Email: medinfo-int@jazzpharma.com