Dobroson: composition and presentation
Dobroson comes as film-coated tablets, each containing 7.5 mg of zopiclone. There is only one strength, but the tablet has a score line, and it is not there for convenience: half a tablet, that is 3.75 mg, is the official starting dose for several groups of patients at once. The leaflet even describes how to break it: the tablet is placed on a table and pressed with the left and right thumb or index finger on either side of the score.
The formulation contains lactose, which matters for people with the rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption — they should not take this medicine. Everything else about Dobroson is about time: how quickly it works, how briefly it is prescribed, and how many hours of sleep must be set aside after a dose to avoid gaps in memory.
How Dobroson works
Zopiclone is a hypnotic close to the benzodiazepines but belonging to a different chemical group, the cyclopyrrolones. Its action comes from a specific agonist effect on the central receptors of the GABAA complex, a multi-molecular structure whose opening lets chloride ions into the cell. The result is the same as with benzodiazepines: the nerve cell becomes less excitable, and in its effect the medicine comes very close to them indeed.
Zopiclone has four pharmacological properties: sedative, anxiolytic, anticonvulsant and skeletal muscle relaxant. Only the first follows from the indication, but the other three do not go anywhere and they explain part of the warnings. It is muscle relaxation that lies behind the risk of falls when an older person gets up at night, and the anxiolytic effect behind the rule that the medicine must not be given as the sole treatment for depression or for anxiety associated with it.
Indications
There is a single indication — short-term treatment of insomnia — and the same section adds a proviso that is worth reading as part of the indication. Benzodiazepines and benzodiazepine-like substances are used solely in severe disturbances, where the patient cannot function normally, or in a state that leaves them severely exhausted.
Put differently, "I have slept badly for a week" is no reason to reach for this medicine. Before treatment starts the underlying cause of the insomnia must be established: it may follow from pain, sleep apnoea, depression, overuse of caffeine or alcohol, or other medicines being taken. In those cases a hypnotic muffles the symptom and leaves the cause untouched, while the period for which it may be prescribed runs out.
Method of use and dosage
Adults are recommended 7.5 mg, that is one tablet, immediately before going to bed; this dose must not be exceeded. In elderly people and in patients with hepatic impairment or chronic respiratory failure, treatment starts at 3.75 mg, half a tablet. The same half is advised as the starting point in renal impairment, even though no accumulation of zopiclone or its metabolites has been found in such patients. In children and adolescents under 18 the medicine is contraindicated.
Duration here is as much a part of the dosage as the number of milligrams. Treatment should last as short a time as possible: usually from a few days to two weeks, at most four weeks, and those four weeks include the period of gradual dose reduction. Extending the course beyond the maximum may prove necessary in particular cases, but the decision must be preceded by a fresh assessment of the patient. One further condition concerns not the dose but the schedule: after taking it, 7 to 8 hours of uninterrupted sleep must be secured, or the risk of memory gaps rises sharply.
Contraindications
Three of the bans on that list follow directly from the pharmacology, and they are easiest to take mechanism by mechanism. Zopiclone relaxes skeletal muscle — so in myasthenia, where the muscles are weak to begin with, it is out of the question. It depresses the respiratory centre — so severe respiratory failure and sleep apnoea syndrome, in which breathing already breaks off at night without any hypnotic, are ruled out. And it is processed by the liver: with severe liver damage, benzodiazepines and benzodiazepine-like substances may contribute to encephalopathy, so they do not suit such patients.
The other two entries are shorter. The first is hypersensitivity to zopiclone or to any excipient, lactose included. The second is age: under 18 the medicine is not used at all, since safety in that group has not been established. Five bans for a whole section is not many, but there is no comfort to draw from that: the main restrictions on this medicine went not here but into the warnings, and there are considerably more of them there.
Special warnings and precautions
The central warning is dependence. Benzodiazepines and benzodiazepine-like substances cause physical and psychological dependence; the risk grows with the dose and with the length of treatment and is markedly higher in those who have abused alcohol or medicines in the past and in those with marked personality disorders. Once physical dependence has formed, abrupt withdrawal produces a withdrawal syndrome: headache and muscle pain, severe anxiety, restlessness, confusion and irritability, and in severe cases derealisation, depersonalisation, sharpened hearing, heightened sensitivity to light, noise or touch, hallucinations and epileptic seizures. The dose is therefore reduced gradually, and the patient is warned about this in advance — both about the brevity of treatment and about exactly how to taper the dose.
| Risk | What it means in practice |
| Rebound phenomenon | after withdrawal the insomnia briefly returns in a stronger form, sometimes with mood swings and anxiety; knowing this in advance means not taking fright and going back to the tablets |
| Withdrawal between doses | with short-acting agents withdrawal symptoms also appear in the intervals between doses, especially at higher doses |
| Tolerance | the hypnotic effect may weaken when treatment is resumed after some weeks; with zopiclone no clear tolerance was seen over four weeks of treatment |
| Anterograde amnesia | arises a few hours after a dose; to reduce the risk, 7 to 8 hours of uninterrupted sleep are needed |
| Paradoxical reactions | instead of calm come agitation and irritability, aggression and fits of rage, delusions, nightmares, hallucinations, psychosis; in children and the elderly this happens more often, and the medicine is then stopped |
| Behaviour during sleep | sleepwalking, driving, preparing and eating food and making phone calls have been reported, often with amnesia afterwards; the risk rises with alcohol, with other agents acting on the nervous system and when the dose is exceeded |
| Falls | from muscle relaxation, above all in older people who get up at night |
| Psychosis and depression | not a first-line agent in psychosis and not the sole medicine in depression or the anxiety tied to it: in the latter case that may lead to suicide |
Driving is dealt with separately. Sedation, amnesia, impaired concentration and disturbed muscle function reduce the ability to drive and to operate machinery; alcohol makes that risk worse and too short a sleep makes it worse still. The patient is warned not to drive until the end of treatment, until it becomes clear that the medicine does not affect their psychophysical ability. Because of the residual effect, the warning extends to the following day as well.
Interactions with other medicines
Alcohol should not be combined with this medicine: it strengthens the sedative effect of zopiclone and, with it, the impairment of driving and machine operation. The same goes for anything that depresses the central nervous system: antipsychotics, hypnotics, anxiolytics, antidepressants, opioid painkillers, antiepileptics, general anaesthetics and sedating antihistamines — combining them with zopiclone calls for separate consideration. Opioid painkillers have a further peculiarity: intensified euphoria and, through it, a growth in psychological dependence. With muscle relaxants zopiclone strengthens their effect.
The second group of interactions follows from the metabolic route: zopiclone is processed by the CYP3A4 isoenzyme. Substances that inhibit that enzyme raise its plasma concentration and strengthen its action — macrolide antibiotics, azole antifungals, HIV protease inhibitors and grapefruit juice; where they are prescribed together, a dose reduction is considered. The scale of the effect is shown by a study of erythromycin in ten healthy volunteers: the area under the zopiclone concentration curve rose by 80%, meaning the hypnotic effect was noticeably stronger. The opposite effect comes from inducers of the same enzyme — phenobarbital, phenytoin, carbamazepine, rifampicin and St John's wort preparations — which lower the concentration of zopiclone and weaken its action.
Pregnancy and breastfeeding
Safety of use in pregnant women has not been established. In animal studies zopiclone crossed the placenta in part but showed no teratogenic effect. The conclusion of the description is cautious: in pregnancy the medicine should not be used unless it is necessary. If for clear medical reasons zopiclone is nevertheless prescribed in the last three months of pregnancy or given during labour, consequences following from the properties of the medicine may be expected in the newborn: hypothermia, low blood pressure, respiratory depression and a weakened sucking reflex — the so-called floppy infant syndrome.
If the mother took zopiclone for a long time in the final months of pregnancy, the baby may show withdrawal symptoms, because physical dependence has had time to form in the child as well. Women of childbearing age are warned when the medicine is prescribed: if they are planning a pregnancy or suspect one, they should see a doctor so that the medicine can be withdrawn. Safety during lactation has not been established either; zopiclone and its metabolites pass into breast milk and, although the concentration there is very low, the medicine should not be given to breastfeeding women.
Adverse reactions
The commonest adverse effect of zopiclone is a bitter or metallic taste in the mouth; in the frequency list it stands in the "very common" category. Common effects are next-day drowsiness, reduced alertness, headache and dizziness, along with gastrointestinal complaints including nausea, vomiting and dyspepsia. Rarely recorded are amnesia, coordination disorders and ataxia, a sensation of vertigo, double vision, dry mouth, muscle weakness and fatigue; ataxia and double vision arise mainly at the start of treatment and generally pass with repeated dosing. Tests rarely show a mild to moderate rise in aminotransferases and alkaline phosphatase; the risk of falls, chiefly in older people, is listed as a separate entry.
Mental reactions are described in more detail than the rest. Rarely there is blunting of emotional responsiveness, confusion and paradoxical reactions — depression, agitation, irritability, aggression, delusions, fits of rage, nightmares, hallucinations, psychosis, behavioural disturbance and dependence; they are sometimes severe, and the risk is higher in children and the elderly. Very rarely libido falls, and with unknown frequency sleepwalking and physical and psychological dependence have been described. A depression that existed before treatment may surface during it. Of the immune reactions, allergic and skin manifestations are rare — itching and rash, including hives — while anaphylactic reactions, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme are very rare.
Overdose
Overdose shows itself as depression of the central nervous system of varying degree, from drowsiness to coma, with the severity depending on the amount taken. In mild cases there is drowsiness, dizziness, disorientation and lethargy; in more serious ones ataxia, reduced muscle tone and blood pressure, methaemoglobinaemia, respiratory depression and coma. In the described cases of zopiclone overdose there were no life-threatening consequences, provided the medicine had not been taken together with alcohol or other substances that depress the nervous system.
Treatment consists of supporting the vital functions and is essentially symptomatic: vomiting is induced and the circulation and breathing are monitored. Haemodialysis is ineffective here because of the large volume of distribution of zopiclone — the substance spreads through the tissues rather than concentrating in the blood, so cleaning the blood achieves nothing. Flumazenil, the same antidote used in benzodiazepine poisoning, may be given.
How to get a Dobroson prescription online
Dobroson is dispensed on prescription, and at e-zdrowie.com it can be arranged remotely. You fill in a medical questionnaire, the doctor reviews the answers and, if the medicine is suitable, issues an electronic prescription: the code arrives by message, and any Polish pharmacy will dispense the tablets against it. The online format does not cancel the main rule of this medicine: it is prescribed for a short course, and the question of extending it is decided afresh each time.
So describe in the questionnaire in detail how long your sleep has been disturbed and what exactly happens — difficulty falling asleep, frequent waking or waking too early — and how the insomnia affects your day. State whether you have taken sleeping medicines before and for how long, whether there is night-time snoring with pauses in breathing, liver and kidney disease, myasthenia, depression or an anxiety disorder. List the medicines you take, including antidepressants, opioid painkillers, antiepileptics, macrolides and antifungals, and mention regular alcohol use. These details determine both the dose and whether a prescription can be issued at all.
