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SLEPLAG is a brand name for Melatonin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Melatonin is indicated for: • for short-term treatment of jet-lag in adults. • Sleep onset insomnia in children and adolescents aged 6-17 years with attention- deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been inadequate. • Delayed sleep wake phase disorder (DSWPD) in children and…
Verbatim from this product's MHRA label. Tap a section to expand.
0 ml) daily for a maximum of 5 days. 0 ml) if the standard dose does not adequately alleviate symptoms. 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.
Due to the potential for incorrectly timed intake of melatonin to have no effect, or 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. g. headache, morning fatigue, concentration) it is recommended that alcohol is not consumed when taking Melatonin.
Melatonin may be taken for a maximum of 16 treatment periods per year.
Sleep onset insomnia in children and adolescents aged 6-17 years with ADHD:
Treatment should be initiated by physicians experienced in ADHD and/or paediatric sleep medicine. 0 ml) 30-60 minutes before bedtime. 0 ml) every week until effect up to a maximum 5 mg (5 ml) per day, independent of age. The lowest effective dose that controls symptoms should be taken for the shortest period.
There is limited data available for up to 3 years of treatment. After at least 3 months of treatment, the physician should evaluate the treatment effect and consider discontinuing the 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. During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should be done regularly at least once per year.
If insomnia has occurred during treatment with ADHD medication, dose adjustment or change of the treatment should be considered. 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.
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. 0 ml) once a day, 1-2 hours before the fixed desired bedtime.
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 additional 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. The frequency of adverse reactions is defined as follows: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1,000 to <1/100), rare (≥1 / 10,000 t o<1/1,000), very rare (<1 / 10,000), not known (frequency cannot be estimated from the available data).
System organ class Common Uncommon Rare Not known (cannot be estimated 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 hyperglycaemia Psychiatric disorders irritability, nervousness, restlessness, abnormal dreams, anxiety mood altered, aggressive behaviour, disorientation, libido increased, depressed mood, depression Nervous system disorders headache, somnolence migraine, lethargy, psychomotor hyperactivity, dizziness syncope (fainting), memory impairment, restless legs syndrome, disturbance in attention, poor quality sleep, paraesthesia drowsiness, sedation Eye disorders visual acuity reduced, vision blurred, lacrimation increased Ear and labyrinth disorders vertigo positional, vertigo Cardiac disorders angina pectoris, palpitations Vascular disorders hypertension hot flushes Gastrointesti nal disorders abdominal pain, upper abdominal pain, dyspepsia, oral ulcers, dry mouth, nausea gastroesophageal reflux disease, gastrointestinal disorder, oral mucosal blistering, tongue ulceration, gastrointestinal upset vomiting, bowel sounds abnormal, flatulence, salivary hypersecretion, halitosis, gastritis Hepatobiliary disorders hyperbilirubinemi a Skin and subcutaneous tissue disorders dermatitis, night sweats, pruritus, rash, generalised itching, dry skin eczema, erythema, hand dermatitis, psoriasis, generalised skin rash, itchy skin rash, nail disorder angioedema, oedema of the tongue, oral mucosal oedema Musculoskele tal and connective tissue disorders pain in extremity arthritis, muscle cramps, muscle spasms, neck pain, night cramps Renal and urinary disorders glycosuria, proteinuria polyuria, haematuria, night urination Reproductive system and breast disorders menopause symptoms priapism, prostatitis galactorrhoea General disorders and administratio n site conditions chest pain, malaise exhaustion, pain, thirst Investigations abnormal liver function, weight increased elevated liver enzymes, abnormal electrolytes Paediatric population In the paediatric population, a low frequency of generally mild side effects have been reported.
Melatonin may cause drowsiness. Melatonin should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. g. epileptic patients). Caution should be exercised when prescribing to patients with epilepsy and/or with multiple neurological defects and/or with concomitant medications that could increase seizure frequency.
Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin. There are no data regarding use of Melatonin in patients with autoimmune diseases. Melatonin 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. Melatonin should be taken at least 2 hours before and at least 2 hours after a meal; ideally at least 3 hours after meal 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. Melatonin is not recommended for use in patients suffering from severe renal impairment or moderate or severe hepatic impairment.
Paediatric population 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 ml) per day, independent of age. The lowest effective dose that controls symptoms should be 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.
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. 0 ml) 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. 0 ml) for those weighing more than 15 kg. 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 interindividual variability. 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 only limited experience regarding the use of Melatonin in patients with hepatic impairment. Limited data indicate that plasma clearance of melatonin is significantly reduced […]
The number of side effects did not differ significantly between children who received placebo and children who received melatonin. The most common side effects were headache, hyperactivity, dizziness and abdominal pain. No serious side effects have been observed.
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.
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. Caution should therefore be exercised in the treatment of this age group and individual dosage is recommended.
Switching between formulations Care should be exercised when changing between different formulations/products as the plasma concentrations with this solution may be higher than that observed with other formulations. Changing formulations may increase the risk of drowsiness or somnolence.
85mg/ml.