Sunosi

Patient Information Leaflet

Sunosi 75 mg film-coated tablets, 150 mg film-coated tablets

solriamfetol
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Sunosi is and what it is used for
2. What you need to know before taking Sunosi
3. How to take Sunosi
4. Possible side effects
5. How to store Sunosi
6. Contents of the pack and other information

1. What Sunosi is and what it is used for

Sunosi contains the active substance solriamfetol. Solriamfetol increases the levels of dopamine and
norepinephrine (noradrenaline), two natural substances, in the brain. Sunosi helps to stay awake and feel
less sleepy.
It is used

• in adults with narcolepsy, a medical condition that causes sudden and unexpected intense sleepiness that can occur at any time. Some patients with narcolepsy also have symptoms of cataplexy (in which muscles become weak in response to emotions such as anger, fear, laughter, or surprise, sometimes leading to collapse);
• to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) in whom EDS has not been satisfactorily managed with primary OSA therapy, such as continuous positive airway pressure (CPAP).

2. What you need to know before taking Sunosi

Do not take Sunosi

• if you are allergic to solriamfetol or to any of the other ingredients of this medicine (listed in section 6)
• if you have had a heart attack within the last year
• if you have severe heart problems, such as recent chest pain, or chest pain that is longer or more severe than usual, uncontrolled high blood pressure despite medication, serious irregular heartbeat, or other serious heart conditions
• if you are taking a type of medicine called a "monoamine oxidase inhibitor" (MAOI) for depression or Parkinson’s disease, or if you have taken one within 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, including psychosis (altered sense of reality) and extreme mood swings (bipolar disorder)
• heart problems, heart attack, or stroke
• high blood pressure
• alcoholism or drug or substance abuse or dependence
• a condition of the eye called closed-angle glaucoma.

Inform your doctor or pharmacist before starting treatment if any of the above apply to you, because
Sunosi may worsen some of these conditions. Your doctor will monitor how the
medicine affects you.
Sunosi does not replace your main treatment for OSA, such as CPAP. You must continue to
use your primary treatment alongside Sunosi.
Children and adolescents
Sunosi is not recommended for children and adolescents under 18 years of age. Safety and
efficacy have not yet been established in this age group.
Other medicines and Sunosi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Do not take Sunosi if:

• you are taking a medicine called a "monoamine oxidase inhibitor" (MAOI) for depression or Parkinson’s disease, or if you have taken one within the last 14 days, because taking an MAOI with Sunosi may increase blood pressure.

Check with your doctor or pharmacist if you are taking medicines that may increase
blood pressure or heart rate, or if you are taking dopaminergic agents (e.g., pramipexole,
levodopa, methylphenidate), used to treat Parkinson’s disease, depression, restless legs syndrome, or
Attention Deficit Hyperactivity Disorder (ADHD).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Sunosi must not be used during pregnancy or in women of childbearing potential who do not use effective
contraceptive measures.
You must not use Sunosi while breastfeeding. You and your doctor must decide whether to discontinue
breastfeeding or to stop or avoid treatment with Sunosi, taking into account the benefits of breastfeeding for you and your baby, and the benefits of treatment for you.
Driving and using machines
You may experience dizziness or impaired concentration; therefore, be especially cautious when
driving or operating machinery.
Consult your doctor or pharmacist if you have any doubts about how your underlying condition or this
medicine may affect you in activities requiring alertness, such as driving or operating machinery:

• at the beginning of treatment
• if your dose is changed

3. How to take Sunosi

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Dose of Sunosi to take
Your doctor will advise you on the dose of Sunosi to take.

• For narcolepsy, treatment usually starts with a dose of 75 mg once daily, taken in the morning upon waking. Some patients may require an initial dose of 150 mg. Your doctor will tell you if this applies to you. Your doctor may prescribe a reduced dose of 37.5 mg. You can obtain this dose by taking half of a 75 mg tablet. The tablet must be divided along the score line.
• For OSA, treatment usually starts with a dose of 37.5 mg once daily, taken in the morning upon waking. You can obtain this dose by taking half of a 75 mg tablet. The tablet must be divided along the score line.
• After at least 3 days of treatment, your doctor may increase the daily dose to the most appropriate level.

The maximum recommended dose of Sunosi is 150 mg per day.
Elderly patients (over 65 years of age)
Take the usual daily dose, 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 adjust your dose.
How to take Sunosi

• Sunosi is a medicine for oral use.
• Take Sunosi by mouth in the morning when you wake up.
• You may take Sunosi with food or between meals.

How long to take Sunosi
You should continue taking Sunosi for the duration specified by your doctor.
If you take more Sunosi than you should
The following symptoms have been observed when patients received 900 mg of Sunosi (6 times the maximum daily dose): uncontrollable movements (tardive dyskinesia) and a feeling of restlessness and inability to remain still (akathisia). These symptoms resolved when Sunosi treatment was discontinued.
Contact your doctor or the nearest emergency department immediately. Take this leaflet and any remaining tablets with you.
If you forget to take Sunosi
If you forget to take your dose at the usual time, you may still take it if more than 9 hours remain before bedtime. Do not take a double dose to make up for a missed dose.
If you stop taking Sunosi
Consult your doctor before stopping treatment with Sunosi.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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, feeling nervous, excessive sweating
• Rapid or irregular heartbeat, also called palpitations, chest discomfort
• High blood pressure
• Feeling unwell, diarrhoea, stomach pain, constipation, vomiting
• Cough, teeth grinding or clenching, dry mouth
• Loss of appetite

Uncommon side effects (may affect up to 1 in 100 people)

• Feeling agitated, restlessness, inability to concentrate, trembling (tremors)
• Heart rate much faster than normal
• Shortness of breath
• Chest pain
• Thirst
• Weight loss

Skin rash, hives, and itching have also been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sunosi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle/blister after "Exp". The expiry date refers to the last day of that month.
Blister: this medicine requires no special storage conditions.
Bottle: after opening, use within 4 months. Keep the container tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sunosi contains
The active substance is solriamfetol.
Sunosi 75 mg film-coated tablets
Each tablet contains solriamfetol hydrochloride, equivalent to 75 mg of solriamfetol.
Sunosi 150 mg film-coated tablets
Each tablet contains solriamfetol hydrochloride, equivalent to 150 mg of solriamfetol.
The other components are:
Tablet core: hydroxypropylcellulose, magnesium stearate
Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172).

Description of the appearance of Sunosi and contents of the pack
Film-coated tablet
Sunosi 75 mg film-coated tablets
Yellow to dark yellow/orange, oblong tablet, printed with “75” on one side and a score line on the other. The tablet can be divided into equal doses.
Sunosi 150 mg film-coated tablets
Yellow, oblong tablet, printed with “150” on one side.
Sunosi is available in blisters of 7 x 1 film-coated tablets in unit-dose perforated PVC/PCTFE/aluminum blisters, packs of 28 and 56 film-coated tablets, and in bottles containing 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Atnahs Pharma Netherlands B.V.
Copenhagen Towers
Ørestads Boulevard 108, 5.tv
DK-2300 København S
Denmark

Manufacturer
Cilatus Manufacturing Services Limited
Pembroke House
28-32 Pembroke Street Upper
Dublin 2
Co. Dublin
D02 EK84
Ireland

Further information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/

ANNEX IV
REASONS FOR A FURTHER RENEWAL

Reasons for a further renewal
Based on data available following the initial marketing authorization, the CHMP considers that the benefit-risk balance of Sunosi remains positive, but considers that its safety profile should be closely monitored for the following reasons:
Frequent changes in the marketing authorization number and transfer of data.
The product information and risk management plan have not been updated with new data from a completed clinical lactation study within a reasonable timeframe.
Therefore, based on the safety profile of Sunosi, the CHMP has concluded that the marketing authorization holder should submit a further renewal application within 5 years.