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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 is indicated for: • Short-term treatment of jet-lag in adults. • Insomnia in children and adolescents aged 6-17 years with ADHD, where sleep hygiene measures have been insufficient.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Jet-lag in adults:
The standard dose is one 3 mg tablet daily at local time to go to bed starting on arrival at destination for a maximum of 4 days. Other dosages from other manufacturers are available to achieve higher than 3 mg dose if required. The dose that adequately alleviates symptoms should be taken for the shortest period.
Due to the potential for incorrectly timed intake of melatonin to have no effect, or to cause an adverse effect, on re-synchronisation following jet-lag, melatonin should not be taken before 20:00 hr or after 04:00 hr at destination.
Paediatric population The safety and efficacy of melatonin in children and adolescents less than 18 years in jet lag has not been established.
Insomnia in children and adolescents aged 6-17 years with ADHD:
Melatonin 3 mg dose is taken 30-60 minutes before bedtime. Ceyesto is suitable only when the lowest effective dose has been established to be 3 mg. Maximum dose: 3 mg. Limited data are available for up to 3 months of treatment. The physician should evaluate the treatment effect at regular intervals and consider stopping treatment if no clinically relevant treatment effect is seen.
If the sleep disorder has started during treatment with medicinal products for ADHD, dose adjustment or switching to another product should be considered. Children below 6 years of age Ceyesto tablets are not recommended for children below 6 years with ADHD.
The safety and efficacy of melatonin in children less than 6 years has not been established. 2). Renal impairment There is only limited experience regarding the use of melatonin in patients with renal impairment. Caution should be exercised if melatonin is used by patients with renal impairment.
2). Hepatic impairment There is no experience regarding the use of melatonin in patients with hepatic impairment. Limited data indicate that plasma clearance of melatonin is significantly reduced in patients with cirrhosis. 2). Method of administration Oral use.
Tablets should be swallowed with a glass of water. 2).
Summary of the safety profile Drowsiness / sleepiness, headache, and dizziness / disorientation are the most frequently reported adverse effects in adults when melatonin is taken on a short-term basis to treat jet-lag. Drowsiness, headache, dizziness, and nausea are the most frequently reported adverse effects when typical clinical doses of melatonin have been taken for periods of several days to several weeks by healthy persons and patients including children and adolescents.
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) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known: (cannot be established from the available data) Infections and infestations herpes zoster Blood and lymphatic system disorders leucopenia, thrombocytopenia Immune system disorders hypersensitivity reaction Metabolism and nutrition disorders hypertriglyceridaemia, hypocalcaemia, hyponatremia Psychiatric disorders irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety mood changes, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, increased libido, depressed mood, depression Nervous system disorders migraine, headache, lethargy, psychomotor hyperactivity, dizziness, somnolence syncope, impaired memory, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, paraesthesia Eye disorders acuity reduced, vision blurred, increased lacrimation Ear and labyrinth disorders positional vertigo, vertigo Cardiac disorders angina pectoris, palpitations Vascular disorders hypertension hot flushes Gastrointestinal disorders abdominal pain, abdominal pain upper, dyspepsia, mouth ulceration, dry mouth, nausea gastro-oesophageal reflux disease, gastrointestinal disorder, oral mucosal blistering, tongue ulceration, gastrointestinal upset, vomiting, bowel sounds abnormal, flatulence, salivary hypersecretion, halitosis, abdominal discomfort, gastric disorder, gastritis Hepatobiliary disorders hyperbiliru- binaemia Skin and subcutaneous tissue disorders dermatitis, night sweats, pruritus, rash, pruritus generalised, dry skin eczema, erythema, hand dermatitis, psoriasis, generalised rash, pruritic rash, nail disorder angioedema, oedema of mouth, tongue oedema Musculoskeletal and connective tissue disorders pain in extremity arthritis, muscle spasms, neck pain, night cramps Renal and urinary disorders glycosuria, proteinuria polyuria, haematuria, nocturia Reproductive system and breast disorders menopausal symptoms priapism, prostatitis galactorrhoea General disorders and administration site conditions asthenia, chest pain fatigue, pain, thirst Investigations liver function test abnormal, weight increased hepatic enzyme increased, blood electrolytes abnormal, laboratory test abnormal Paediatric population A low frequency of in general mild adverse reactions have been reported in the literature and paediatric population in short-term use (up to 4 weeks).
g. epileptic patients). Patients suffering from seizures must be informed about this possibility before using Melatonin 3 mg film-coated tablets. Melatonin may promote or increase the incidence of seizures in children and adolescents with multiple neurological defects.
Drowsiness Melatonin may cause drowsiness. 7). Autoimmune diseases No clinical data exist concerning the use of melatonin in individuals with autoimmune diseases. Therefore, melatonin is not recommended for use in patients with autoimmune diseases.
Hepatic and renal impairment There is only limited experience of safety and efficacy regarding the use of melatonin in patients with hepatic or renal impairment. 2). Cardiovascular conditions There is limited data that melatonin may cause adverse effects on blood pressure and heart rate in populations with cardiovascular conditions and concurrent antihypertensive medications.
It is unclear whether these adverse effects are attributable to melatonin itself or to melatonin-drug interactions. Melatonin is not recommended for use in patients with cardiovascular conditions and concurrent antihypertensive medication.
5). Children and adolescents Currently the safety profile of melatonin in children and adolescents is not fully established, especially in long-term use. Long-term melatonin use may negatively affect blood glucose control, pubertal development and sexual maturation.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The number of adverse reactions has not differed significantly between children who have received placebo compared to melatonin. The most common adverse reactions were headache, hyperactivity, dizziness and abdominal pain. No serious adverse reactions have been observed.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.