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Pharmacological properties

Donormyl is a sleeping pill for the class of ethanolamines of the group of n1 receptor blockers. It has a sedative and m-anticholinergic effect. reduces the time of falling asleep, increases the duration and quality of sleep, without affecting its physiological phases.

Pharmacokinetics Doxylamine succinate is well absorbed in the digestive tract, Cmax in blood plasma is achieved 1 h after administration, T½ - 10 hours. A small amount of metabolites are formed, but the main part (about 60%) is excreted unchanged in the urine. There are no data on the ability of doxylamine to pass into breast milk, but this should not be excluded.

Indications

Insomnia.

Application

In adults and adolescents over the age of 15 years - 7.5-15 mg per 1 dose for 15-30 minutes before bedtime (in the evening). if necessary, increase the dose to 2 tablets. the duration of treatment is 2–5 days.

The coated tablet is washed down with water.

Before taking the effervescent tablet is dissolved in 1/2 glasses of water.

Contraindications

Angle-closure glaucoma, difficulty urinating (diseases of the urethra and prostate gland); age up to 15 years, hypersensitivity to the drug.

Side effects

In the morning, after an evening intake of the drug, a slowdown in reactions and a feeling of dizziness may be noted, therefore, to prevent a fall, sudden movements should be avoided.

The anticholinergic effect of the drug may manifest as constipation, dry mouth, urinary retention, and disturbance of accommodation.

special instructions

Donormyl has no teratogenic and fetotoxic effects, however, the question of its use during pregnancy should be agreed with the doctor. Donormyl in small amounts can be excreted in breast milk, so you should not use the drug during lactation.

Coated tablets contain lactose, which should be considered for individuals with impaired absorption of lactose, glucose-galactose.

Individuals who restrict sodium intake should be aware that 1 effervescent tablet contains 484 mg of sodium.

To prevent drowsiness throughout the day, it must be remembered that the duration of sleep after taking Donormyl should be at least 7 hours.

Donormyl affects the speed of psychomotor reactions, this should be taken into account by drivers and people who work with complex mechanisms.

Interactions

With simultaneous administration with barbiturates, benzodiazepine, clonidine, opioid analgesics, antipsychotics, tranquilizers, an increase in the inhibitory effect of Donormyl on the central nervous system is noted.

With the simultaneous administration of Donormyl and atropine or other M-anticholinergic drugs, the risk of anticholinergic side effects, such as dry mouth, urinary retention, increases. Alcohol enhances the sedative effect of Donormyl.

Overdose

When taking coated tablets, accidental or deliberate overdose is possible only at very high doses. a significant overdose of effervescent tablets is almost impossible.

Symptoms of poisoning are due to the anticholinergic action of doxylamine.

Symptoms: mydriasis, facial skin hyperemia, hyperthermia, anxiety, impaired coordination, tremor, athetous movements, convulsions. If untreated, a coma may develop, accompanied by collapse.

Treatment: taking activated charcoal (50 g for adults and 1 g / kg body weight for children), symptomatic treatment.

Storage conditions

In a dry place inaccessible to children at a temperature of 15-25 ° C.

Actual information

Sleep is a natural physiological state of the body. the optimal number of hours for sleep varies by age group. for example, to restore strength, Americans spend much less time on a night’s sleep than they need.Surveys conducted by the US National Sleep Foundation (NSF) show that Americans have an average of 6 hours and 31 minutes of sleep at night, about an hour less than their average 7 hours and 13 minutes. nsf recently published recommendations on the appropriate amount of time to sleep at different ages (hirshkowitz et al., 2015). The American Academy of Sleep Medicine has also developed recommendations, but they are still under discussion.

Sleep disorders, insomnia

Sleep can be disturbed for various reasons, these are external and internal factors. External factors include exposure to environmental irritants, such as excessive noise and light during sleep; as well as voluntary sleep restriction. For example, in hospitals, the need to care for patients during the night can disrupt their sleep. Internal factors include human health and related illnesses, as well as symptoms, such as pain; adverse reactions that occur to drugs used to treat a particular pathology. Other factors include circadian rhythm disturbances (internal biological rhythms of the body) and an increase in the prevalence of primary sleep disorders, such as narcolepsy (diseases of the nervous system related to hypersomnia), various parasomnias (behavioral disorders in different phases of sleep), and respiratory / shortness of breath in sleep.

Insomnia should be distinguished from sleep disturbance. Insomnia (insomnia) is a widespread pathological condition / disorder characterized by the presence of sleep problems. It is characterized by problems with the initiation, duration and continuity of sleep. These problems always occur amid sufficient time to fall asleep and good sleeping conditions. Further, after sleep, there is a violation of daily activity (A. Melnikov, et al., 2017). The term “insomnia” refers to a condition that occurs at least 3 times a week for 1 month (Roth, 2007). Also distinguish such a thing as chronic insomnia - a state of insomnia, which lasts 3 months or more; short-term (acute) insomnia - less than 3 months. Sleep disturbances, on the contrary, are characterized by disturbances during sleep itself, 1-2 nights a week for 2 weeks and are not specific. Such disturbances may be the result of a striking event during daytime life (for example, trauma or a change in time zones) or a symptom of other sleep disorders. OTC drugs (OTC group) are prescribed when short-term (acute) insomnia occurs. Since in the absence of adequate treatment, this type of insomnia can turn into chronic, which can be treated much worse. The main problem in the study of healthy sleep and the OTC drugs used is the confusion between insomnia and sleep disturbance. Unfortunately, when examining sleep health, as a rule, they do not distinguish between them.

In the United States, information on the prevalence of age-related sleep disturbances is available at the Center for Disease Control and Prevention (CDC) under the Behavioral Risk Factor Monitoring (BRFSS) module. Sleep disturbance in the BRFSS system is detected using the question: “How many days have you had problems falling asleep or sleeping in the last 2 weeks? Or how long your sleep was during this period. ” The 2-week period shows acute sleep disturbance in the elderly (Grandner et al., 2012). Studies involving older people show that older people without medical or psychiatric problems are less likely to have sleep problems and that sleep disturbances are not normal for the aging period (Vitiello et al., 2002). Healthy elderly people have a much smaller number of periods of sleep disturbance than people with multimorbidity (the presence of two or more chronic / recurrent conditions / diseases) (Ohayon et al., 2004).In general, the more chronic diseases and the higher their severity, the worse people sleep (Zee Turek, 2006). Diseases that affect healthy sleep include diabetes mellitus, cardiovascular disease, respiratory diseases, mood disorders (affective disorders), decreased cognitive function, pain conditions, and neurological disorders (McCurry et al., 2007). New research also points to a bi-directional relationship between sleep disturbances and certain conditions, such as dementia, pain, and depression. For example, sleep loss increases the level of amyloid-β in the brain, and its accumulation is associated with Alzheimers disease. With an increase in amyloid-β level, we observe an increase in the wakefulness period and a change in the sleep period (Ju, Lucey, Holtzman, 2014).

OTC drugs used for insomnia

Among sleeping pills in the treatment of insomnia, H blockers are widely used.1histamine receptors such as doxylamine succinate (a drug Donormyl) In 1948, doxylamine first appeared on the pharmaceutical market. It is characterized by antihistamines, sedatives and antiemetics. Due to its antiemetic effect in the countries of Europe and the USA, it is prescribed as part of complex therapy to eliminate nausea in pregnant women. In studies, a positive effect of taking the drug with insomnia was established. In many countries, doxylamine is an OTC (over-the-counter) drug. This group of drugs does not cause addiction and withdrawal. It can be used in cases where other drugs are contraindicated (A. Melnikov et al., 2017).

All available over-the-counter medicines for the treatment of insomnia contain diphenhydramine or doxylamine (the drug Donormyl), with this violation also use the first generation antihistamines approved by the FDA in the form of mono - or complex therapy, for example, with over-the-counter analgesics.

Available evidence suggests that non-drug treatments for chronic insomnia, such as cognitive-behavioral therapy, relaxation techniques, or exercise, are also effective for the elderly. Nevertheless, additional studies of the effectiveness of non-drug treatments for accidental sleep disorders, as opposed to chronic insomnia, are needed to determine whether these approaches are effective in elderly and young people with acute sleep disorders.

As a result of the long period of use of the first generation antihistamines for the treatment of allergic diseases, it was found that these drugs have sedative properties. In fact, these drugs are often called "sedative antihistamines." However, are these properties effective for the treatment of acute or chronic insomnia, since diphenhydramine and doxylamine were released to the pharmaceutical market before 1972. Namely this year, the FDA published new requirements for OTC drugs, and drugs released before this year under these requirements did not fall. The requirements for new drugs are randomized, placebo-controlled trials that are required to approve a new drug application.

Similarly, the risks and benefits of OTC sleeping pills for treating sleep disturbance have not been studied in randomized controlled trials. There are no published published controlled studies examining the use of doxylamine for treating insomnia. The most positive published study confirming the use of diphenhydramine as an adjuvant for sleep showed that 50 mg of diphenhydramine significantly improves sleep, minimizes the process of falling asleep, and in the morning a person feels rested compared to placebo (Rickels et al., 1983).However, other published data, which use both patient reports and objective sleep indicators, are less positive (Morin, Koetter, Bastien, Ware Wooten, 2005).

findings

Productive night sleep can be a problem for older people with chronic illnesses. As a result, many elderly people take over-the-counter medicines, such as doxylamine, to solve this problem (Donormyl).

Elderly people are more likely to take diphenhydramine or doxylamine (Donormyl) for 15 or more days per month, which is an indicator of improper use.

In the annotation for doxylamine, the manufacturer recommends stopping the use of the drug and consult a doctor if insomnia persists for more than 2 weeks. Nevertheless, a large number of elderly patients use this drug constantly.

Possible adverse reactions such as dry mouth, palpitations, constipation, urinary retention, headache, tremors, dizziness, disturbance of accommodation, drowsiness after waking up. However, the side effects of the drug are rarely severe, are not a reason for canceling.

Signs of an overdose include shortness of breath, chest pain, fever, itching, severe coughing, blue complexion, cramps, swelling of the face, lips, tongue, or throat. The treatment is symptomatic.

Additional studies are needed to evaluate the pharmacokinetics and pharmacodynamics of doxylamine, especially in the elderly (Albert S.M. et al., 2017).

Research

A multicenter comparative randomized trial compared the efficacy of doxylamine in acute insomnia compared to Donormyl.

This study was conducted in 6 medical institutions; 60 patients with short-term insomnia aged 30–59 years took part in it. Patients were divided into 2 groups: in the first group, patients took one of the doxylamine preparations, and in the second Donormyl in the same dose and mode of application.

Complete clinical remission of insomnia was achieved in most patients of both groups. The rates of insomnia severity, sleep quality and daytime sleepiness in both groups improved with high rates. Adverse reactions were mild and in most cases did not lead to discontinuation of treatment. There were no significant differences between the groups in terms of clinical efficacy.

Short-term use of the drug Donormyl it has a pronounced positive clinical effect in acute insomnia; satisfactory tolerance of the drug to patients is also characteristic (A. Melnikov et al., 2017).