SUNOSI Film-coated tablet Ref.[114520] Active ingredients: Solriamfetol

Psychiatric symptoms

Solriamfetol has not been evaluated in patients with a history of or concurrent psychosis or bipolar disorders. Caution should be exercised when treating these patients due to psychiatric adverse reactions that could exacerbate symptoms (e.g. manic episodes) of pre-existing psychiatric disorders.

Patients treated with solriamfetol should be carefully monitored for adverse reactions such as anxiety, insomnia and irritability. These adverse reactions were commonly observed during treatment initiation, but tended to resolve with continued treatment. If these symptoms persist or worsen, dose reduction or discontinuation should be considered.

Blood pressure and heart rate

Analyses of data from clinical trials showed that treatment with solriamfetol increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose dependent fashion.

Epidemiological data show that chronic elevations in blood pressure increase the risk of major adverse cardiovascular event (MACE), including stroke, heart attack and cardiovascular death. The magnitude of the increase in absolute risk is dependent on the increase in blood pressure and the underlying risk of MACE in the population being treated. Many patients with narcolepsy and OSA have multiple risk factors for MACE, including hypertension, diabetes, hyperlipidemia and high body mass index (BMI).

Use in patients with unstable cardiovascular disease, serious heart arrhythmias and other serious heart problems is contraindicated (see section 4.3).

Patients with moderate or severe renal impairment may be at a higher risk of increases in blood pressure and heart rate because of the prolonged half-life of solriamfetol.

Abuse

Sunosi was assessed in a human abuse potential study and demonstrated low abuse potential. Results from this clinical study demonstrated that solriamfetol produced Drug Liking scores higher than placebo, but generally similar or lower than phentermine (a weak stimulant). Caution should be exercised when treating patients with a history of stimulant (e.g. methylphenidate, amphetamine) or alcohol abuse, and these patients should be monitored for signs of misuse or abuse of solriamfetol.

Angle closure glaucoma

Mydriasis may occur in patients taking solriamfetol. Caution is advised in patients with increased ocular pressure or at risk of angle closure glaucoma.

Women of childbearing potential or their partners

Women of childbearing potential or their male partners must use effective method of contraception while taking solriamfetol (see section 4.6).

No interaction studies have been performed (see section 5.2).

Solriamfetol must not be administered concomitantly with MAOIs or within 14 days after MAOI treatment has been discontinued because it may increase the risk of a hypertensive reaction (see section 4.3).

Concomitant use of medicinal products that increase blood pressure and heart rate should be used with caution (see section 4.4).

Medicinal products that increase levels of dopamine or that bind directly to dopamine receptors might result in pharmacodynamic interactions with solriamfetol. Concomitant use of such medicinal products should be used with caution.

Pregnancy

There are no or limited amount of data from the use of solriamfetol in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). Sunosi is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

It is unknown whether solriamfetol is excreted into human milk. Animal studies have shown excretion of solriamfetol in milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Sunosi therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the women.

Fertility

The effects of solriamfetol in humans are unknown. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).

Minor influence on the ability to drive is expected in patients receiving stable solriamfetol doses. Dizziness and disturbance in attention may occur following administration of solriamfetol (see section 4.8).

Patients with abnormal levels of sleepiness who take solriamfetol should be advised that their level of wakefulness may not return to normal. Patients with excessive daytime sleepiness, including those taking solriamfetol should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity, especially at the start of the treatment or when the dose is changed.

Summary of the safety profile

The most frequently reported adverse reactions were headache (11.1%), nausea (6.6%) and decreased appetite (6.8%).

Tabulated list of adverse reactions

The frequency of adverse reactions is defined using the following MedDRA frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Description of selected adverse reactions

Treatment initiation

The majority of the most frequently reported adverse reactions occurred within the first 2 weeks of initiating treatment and resolved for the majority of patients with a median duration of less than 2 weeks.

Hypersensitivity reactions

In post-marketing experience, there have been reports of hypersensitivity reactions which have occurred with one or more of the following: rash erythematous, rash, urticaria (see section 4.3).

Dose-dependent adverse reactions

In the 12-week clinical trials that compared doses of 37.5 mg, 75 mg and 150 mg/day of solriamfetol to placebo, the following adverse reactions were dose-related: headache, nausea, decreased appetite, anxiety, diarrhoea and dry mouth. The dose relationships were generally similar in OSA and narcolepsy patients. Certain events such as anxiety, insomnia, irritability, and agitation were commonly observed during treatment initiation, but tended to resolve with continued treatment. If these symptoms persist or worsen, dose reduction or discontinuation should be considered (see section 4.4).

Discontinuation of treatment

In the 12-week placebo-controlled clinical trials, 11 of the 396 patients (3%) who received solriamfetol discontinued due to an adverse reaction compared to 1 of the 226 patients (<1%) who received placebo. The adverse reactions leading to discontinuation that occurred in more than one solriamfetol-treated patients and at a higher rate than placebo were anxiety, palpitations and restlessness, all of which occurred with a frequency less than 1%.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.