|For this product no modern clinical documentation is available to determine frequency of adverse effects.Bitter taste is the most common side effect observed with Zopiclone.|
*Due to the myrolexant effect there is a risk of falls and consequently fractures in older patients.Drowsiness, affective blunting, alertness decreased, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision occurs predominantly at the start of the therapy and usually disappear with repeated administration.Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour (see Section 4.4 Special Warnings and Special Precautions for Use).Pre-existing depression may be unmasked during benzodiazepines and benzodiazepine-like agents use.Reactions like restlessness agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychosis and abnormal behaviour are more likely to occur in children and the elderly.
| ||Frequency|| |
|MedDRA SOC||Very rare(<1/10,000)||Not known |
|Investigations||Transaminases increased, alkaline phosphatise increased (changes in liver function detected by a blood test)
|Nervous system disorders|| ||Taste bitter, drowsiness, alertness decreased, confusion, headache, dizziness, muscle weakness, ataxia, double vision, anterograde amnesia.
|Gastrointestinal disorders|| ||Gastrointestinal disorder, dyspepsia, nausea, dry mouth
|General disorders andadministration site conditions|| ||Fatigue
|Musculosketal and connective tissue disorders|| ||Muscle weakness*
|Immune system disorders||Angioedema (rapid swelling of the face, tongue or throat which can cause breathing and swallowing problems), anaphylactic
Reaction (a life-threatening type of allergic reaction)
||Allergic reactions (such as pruritus or rash)
|Psychiatric disorders|| ||Affective blunting, libido disorder, restlessness, agitation, irritability, aggressiveness, delusion, rage, nightmare, hallucination, psychosis, abnormal behaviour, drug dependence physical, drug dependence psychic, sleep walking
DependenceUse (even at therapeutic doses) may lead to the development of physical dependence. Psychic dependence may occur.Abuse of benzodiazepines and benzodiazepine-like agents has been reported. Discontinuation of the therapy may result in withdrawal or rebound phenomena. Withdrawal syndrome has been reported upon discontinuation of zopiclone (see 4.4, Special Warnings and Special Precautions for Use).Withdrawal symptoms vary and may include rebound insomnia, anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, and irritability. In very rare cases seizures may occur.
Reporting of suspected adverse reactionsReporting 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org.