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CEYESTO is a brand name for Melatonin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ceyesto / Melatonin ALTURiX 1 mg/ml Oral Solution is indicated for: (i) Delayed sleep wake phase disorder (DSWPD) in children and adolescents aged 6-17 years and adults up to 25 years of age, where sleep hygiene measures have been insufficient. (ii) Short-term treatment of jet lag in adults. (iii) Insomnia in children…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Delayed sleep wake phase disorder In children and adolescents (6-17 years) and adults up to 25 years of age: Treatment should be initiated by physicians experienced in DSWPD and/or paediatric sleep medicine. The recommended starting dose is 1 to 2 mg once a day, 1-2 hours before the fixed desired bedtime, given as 1-2 ml of the oral solution.
The dose of melatonin should be adjusted individually until effective up to a maximum of 5 mg per day, independent of age. The lowest effective dose should be sought and taken for the shortest period. After 6 weeks of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen.
In patients with significant continuing daytime sleepiness or misaligned circadian rhythm the possibility of high residual melatonin in the morning should be considered. In these cases melatonin can be stopped and restarted at a lower dose.
The dose that adequately alleviates symptoms should be taken for the shortest period. There is insufficient safety data to support long term use of melatonin in children approaching puberty. After the achievement of advanced sleep-wake phase for 6 weeks, treatment should be stopped to evaluate if the patient can independently maintain an advanced sleep-wake schedule.
If withdrawal of melatonin results in clinical relapse, melatonin can be resumed and continued. 4). Adults over 25 years of age In adults whose symptoms persist past the age of 25 and who have shown clear benefit from treatment, it may be appropriate to continue treatment.
However, initiation of treatment in adults over 25 years of age is not appropriate.
Short-term treatment of jet lag in adults:
The standard dose is 3 mg daily, taken as 3 ml of the oral solution for a maximum of 5 days. If the standard dose does not adequately alleviate symptoms, the dose may be increased to 6 mg, taken as 6 ml of the oral solution. The dose that adequately alleviates symptoms should be taken for the shortest period.
The first dose should be taken on arrival at destination at the habitual bed-time in the time zone. Due to the potential for incorrectly timed intake of melatonin to have no effect, or an adverse effect, on resynchronization following jet-lag, this medicinal product should not be taken before 20:00 hr or after 04:00 hr at destination.
Summary of the safety profile After single doses of melatonin, nausea and vomiting were common adverse effects. Drowsiness / sleepiness, headache, and dizziness / disorientation are the most frequently reported adverse effects when melatonin is taken on a short-term basis.
Gastrointestinal symptoms, drowsiness, headache and dizziness are also adverse effects reported most frequently when typical clinical doses of melatonin have been taken for periods of several days to several weeks by healthy persons and patients.
In longer term treatment of up to several months no additonal long term adverse effects were seen, except an uncommon effect of abnormal dreams. Tabulated list adverse reactions The following adverse reactions to melatonin in general have been reported in clinical trials or spontaneous case reports.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommen (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not Known: Cannot be established from the available data Blood and lymphatic system disorders Leucopenia, thrombocytope- nia Immune system disorders Hypersensitivity reaction Metabolism and nutrition disorders Hypertriglycerid- aemia Hyperglycaemia Psychiatric disorders Irritability, nervousness, restlessness, abnormal dreams, anxiety Mood altered, aggressive behaviour, disorientation, libido increased Nervous system disorders Headache, somnolence Dizziness Syncope (fainting), memory impairment, restless legs syndrome, paraesthesia Eye disorders Visual acuity reduced, vision blurred, lacrimation increased Ear and labyrinth disorders Vertigo positional, vertigo Cardiac disorders Palpitations Vascular disorders Hypertension Hot flushes Gastrointestinal disorders Abdominal pain, upper abdominal pain, dyspepsia, oral ulcers, dry mouth, nausea Vomiting, flatulence, salivary hypersecretion, halitosis, gastritis Skin and subcutaneous tissue disorders Pruritus, rash, dry skin Nail disorder Tongue edema, edema of the oral mucosa Musculoskeletal and connective tissue disorders Arthritis, muscle spasms Renal and urinary disorders Glycosuria, proteinuria Polyuria, haematuria Reproductive system and breast disorders Priapism, prostatitis Galactorrhoea General disorders and administration site conditions Chest pain, malaise Thirst Laboratory and other examinations Liver function test abnormal, weight increased Blood electrolytes abnormal Paediatric population A low frequency of in general mild adverse reactions have been reported in the paediatric population.
Melatonin may cause drowsiness. This medicinal product should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. Melatonin has been reported to increase, decrease and have no effect on seizure frequency.
Because of the uncertainty of the effect of melatonin on epileptic seizures, some caution should be exercised for use in people with epilepsy. Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin.
There are no data regarding use of this medicinal product in patients with autoimmune diseases. This medicinal product is not recommended in patients with autoimmune diseases. Limited data suggest that melatonin taken in close proximity to ingestion of carbohydrate-rich meals may impair blood glucose control for several hours.
This medicinal product should be taken at least 2 hours before and at least 2 hours after a meal; ideally at least 3 hours after meals by persons with significantly impaired glucose tolerance or diabetes. Only limited data are available on the safety and efficiency of melatonin in patients with renal impairment or hepatic impairment.
This medicinal product is not recommended for use in patients suffering from severe renal impairment or moderate or severe hepatic impairment. Children and Adolescents There is insufficient data to analyse the impact of long-term exposure to melatonin in children and adolescents on the sexual maturation of this population.
g. immunological regulation, effects on the threshold for seizures and endocrinological effects, which could affect puberty development and fertility, respectively. Therefore, treatment should be taken for the shortest period and evaluated on a regular basis (at least every 6 months) to check that melatonin is still the most appropriate treatment.
Elderly (65 years old and over) Exposure levels to melatonin after oral administration in young and moderately older adults are comparable. Although prolonged elevated levels of melatonin have been seen in some elderly patients it is unclear if all significantly older persons are especially sensitive to exogenous melatonin.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This medicinal product may be taken for a maximum of 16 treatment periods per year. Insomnia in children and adolescents aged 6-17 years with attention deficit hyperactivity disorder Treatment should be initiated by physicians experienced in ADHD and/or paediatric sleep medicine.
The recommended starting dose is 1-2 mg, 30-60 minutes before bedtime. The dose of melatonin should be adjusted individually until effective up to a maximum of 5 mg per day, independent of age. The lowest effective dose should be sought and taken for the shortest period.
The dose that adequately alleviates symptoms should be taken for the shortest period. There is insufficient safety data to support long term use of melatonin in children approaching puberty. After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen.
The patient should be monitored at regular intervals (at least every 6 months) to check that melatonin is still the most appropriate treatment. g. once per year and treatment discontinued if it is not effective. If the sleep disorder has started during treatment with other medicinal products, dose adjustment or switching to another product should be considered.
If significant problems are seen in sleep maintenance or early morning waking, an alternative formulation of melatonin should be considered. 4). Adults In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood.
However, initiation of treatment in adults is not appropriate. Single use for short-term sedation under medical supervision to facilitate EEG in children and adolescents from 1 to 18 years Melatonin should be given 30-45 minutes before the anticipated start of the procedure as a single dose of 3mg for children weighing less than 15 kg and 6 mg for those weighing more than 15 kg.
Where possible this dose should be administered after a period of sleep deprivation to maximise the sedative effects. 5 mg (<15 kg) or 3 mg (>15 kg) may be given if sleep is not achieved after 45 minutes. 5 mg in children weighing less than 15 kg and 9 mg for those weighing more than 15 kg.
Due to the presence of benzyl alcohol in the formulation and the risk of accumulation especially in younger children it is not recommended to perform more than one melatonin assisted EEG in each 24 hour period. 2). However, individual elderly patients may be more likely to be slow metabolisers of melatonin with the potential for high residual morning levels of melatonin.
In cases where there is excessive morning sleepiness, a lack of effect on DLMO and / or advancing sleep phase the possibility of impaired melatonin clearance, too high a dose, or too late a time of administration should be considered.
Genetic polymorphisms of CYP enzymes and other slow metabolisers Polymorphisms in CYP1A2, CYP1A1 and CYP2C19 may affect first pass metabolism and systemic clearance of melatonin contributing to […]
The number of adverse reactions has not differed significantly between children who have received placebo compared to melatonin. The most common adverse reactions were dizziness, headache, gastrointestinal symptoms and increased excitability.
No serious adverse reactions have been observed when high quality synthetic melatonin was given together with the currently recommended posology. 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. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
Caution should therefore be exercised in the treatment of this age group and individual dosage is recommended. Excipient warnings This medicinal product contains 6mg / ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions and has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
The minimum amount of benzyl alcohol at which toxicity may occur is not known. Benzyl alcohol containing products should not be used in pre-term or full-term neonates (up to 4 weeks) unless strictly necessary. Large amounts of benzyl alcohol can build-up in the body and may cause side effects (metabolic acidosis).
Large volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment or those that are pregnant or breast-feeding. Caution is also advised in young children (< 3 years) due to the risk of accumulation.
This medicinal product contains 52mg / ml of propylene glycol. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates. This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.