Adverse reactions : תופעות לוואי

4.8 Undesirable effects

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).

System Organ Class             Adverse reactions           Frequency
Metabolism and nutrition
Decreased appetite          Common disorders
Anxiety                     Common
Insomnia                    Common
Irritability                Common
Psychiatric disorders
Bruxism                     Common
Agitation                   Uncommon
Restlessness                Uncommon
Headache                    Very common
Dizziness                   Common
Nervous system disorders
Disturbance in attention    Uncommon
Tremor                      Uncommon
Palpitations                Common
Cardiac disorders
Tachycardia                 Uncommon
Vascular Disorders             Hypertension                Uncommon
Respiratory, thoracic and     Cough                         Common mediastinal disorders         Dyspnoea                      Uncommon
Nausea                        Common
Diarrhoea                     Common
Dry mouth                     Common
Gastrointestinal disorders
Abdominal pain                Common
Constipation                  Common
Vomiting                      Common
Skin and subcutaneous
Hyperhidrosis                 Common tissue disorders
Feeling jittery               Common
General disorders and
Chest discomfort              Common administration site
Chest pain                    Uncommon conditions
Thirst                        Uncommon
Heart rate increased          Uncommon
Investigations                Blood pressure increased      Common
Weight decreased              Uncommon

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com