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Sonata is a brand name for Zaleplon. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Verbatim from this product's EMA label. Tap a section to expand.
For adults, the recommended dose is 10 mg. Treatment should be as short as possible with a maximum duration of two weeks. Sonata can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep.
As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Sonata. The total daily dose of Sonata should not exceed 10 mg in any patient.
Patients should be advised not to take a second dose within a single night. Elderly Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Sonata. 3). Hepatic impairment As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg.
Medicinal product no longer authorised 3 Renal impairment No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata pharmacokinetics is not altered in such patients. ).
The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and dysmenorrhea. Frequencies are defined as 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)Medicinal product no longer authorised 7 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Organ/System (Frequency) Adverse Reactions Nervous system disorders Common:
Uncommon: amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia See also below under Amnesia Eye disorders Uncommon: visual impairment, diplopia Ear and labyrinth disorders Uncommon: hyperacusis Gastrointestinal disorders Uncommon: nausea Skin and subcutaneous tissue disorders Uncommon: Frequency not known: photosensitivity reaction angioedema Metabolism and nutrition disorders Uncommon: anorexia General disorders and administration site conditions Uncommon: asthenia, malaise Immune system disorders Very rare: anaphylactic/anaphylactoid reactions Hepatobiliary disorders Frequency not known: hepatotoxicity (mostly described as transaminase increased) Reproductive system and breast disorders Common: dysmenorrhea Psychiatric disorders Uncommon: Frequency not known: depersonalisation, hallucinations, depression, confusional state, apathy somnambulism See also below under Depression and Psychiatric and “paradoxical” reactions Amnesia Anterograde amnesia may occur using recommended therapeutic dosages, the risk increasing at higher dosages.
4). Medicinal product no longer authorised 8 Psychiatric and “paradoxical” reactions Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character, and other adverse behavioural reactions are known to occur when using benzodiazepines or benzodiazepine-like agents.
, driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients taking sedativehypnotics. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons.
Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with sedative-hypnotics appears to increase the risk of such behaviours, as does exceeding the maximum recommended dose.
Due to the risk to the patient and the community, discontinuation of zaleplon is recommended for patients who report a “sleep-driving” episode. , preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
As with sleep-driving, patients usually do not remember these events. Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon.
Some patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal.
Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the active substance. Insomnia may represent an underlying physical or psychiatric disorder. Insomnia that persists or worsens after a short course of zaleplon treatment may indicate a need to re-evaluate the patient.
Due to zaleplon’s short plasma half-life, alternative therapy should be considered if early morning awakening is experienced. Patients should be advised not to take a second dose within a single night. Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon’s plasma concentrations.
1. Severe hepatic impairment Severe renal impairment Sleep apnoea syndrome Myasthenia gravis Severe respiratory insufficiency Children and adolescents (under 18 years of age)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Zaleplon in European Union.
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Such reactions are more likely to occur in the elderly. 4). Psychic dependence may occur. Abuse of benzodiazepines and benzodiazepine-like active substances has been reported. 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.
5). Concomitant intake with alcohol is not recommended. 7). Medicinal product no longer authorised 4 Dependence Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence. The risk of dependence increases with dose and duration of treatment and is greater with patients having a history of alcohol and medicinal product abuse.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: unreality, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
There have been post-marketing reports of dependence associated with zaleplon, predominantly in combination with other psychotropic agents. Rebound insomnia and anxiety A transient syndrome whereby the symptoms that led to the treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of treatment.
It may be accompanied by other reactions including mood changes, anxiety, or sleep disturbances and restlessness. 2), and should not exceed two weeks. Extension beyond these periods should not take place without clinical re-evaluation of the patient.
It may be useful to inform the patient when treatment is started that it will be of limited duration. It is important that patients be aware of the possibility of rebound phenomena, thereby minimising anxiety should such symptoms develop when the medicinal product is discontinued.
Memory and psychomotor impairment Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment. These occur most often up to several hours after ingesting the product. 7). Psychiatric and “paradoxical” reactions Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
They may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. These reactions are more likely to occur in the elderly. Should this occur, use of this product should be discontinued.
Any new behavioural sign or symptom requires careful and immediate evaluation. Specific patient groups Alcohol and medicinal product abuse Benzodiazepine and benzodiazepine-like agents should be used with extreme caution in patients with a history of alcohol or medicinal product abuse.
2). In patients with mild to moderate hepatic insufficiency, the bioavailability of zaleplon is […]