Son-night

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SON-NIGHT (SON-NIGHT)

Composition:

Active ingredient: doxylamine;

1 tablet contains: doxylamine succinate 15.00 mg;

Excipients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium croscarmellose; hypromellose; polyethylene glycol 400; coloring suspension containing hypromellose, titanium dioxide (E 171), propylene glycol, purified water.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets, almost white in color, round cylindrical shape, with two convex surfaces and a score line on one side.

Pharmacotherapeutic group.

Antihistamines for systemic use. ATC code R06A A09.

Hypnotics and sedatives. ATC code N05C M.

Pharmacological properties.

Pharmacodynamics.

Doxylamine succinate is an H1-histamine receptor blocker of the ethylenediamine class, having sedative and atropine-like effects. It has been shown to reduce the time required to fall asleep, as well as to improve sleep duration and quality.

Pharmacokinetics.

Maximum plasma concentration (Cmax) is reached on average within 2 hours (Tmax) after administration of doxylamine succinate.

The mean elimination half-life from plasma (T½) averages 10 hours. Doxylamine succinate is partially metabolized in the liver via demethylation and N-acetylation. The elimination half-life may be significantly prolonged in elderly individuals and in patients with renal or hepatic impairment. Various metabolites formed during the breakdown of the molecule are not quantitatively significant, as 60% of the administered dose is excreted in urine as unchanged doxylamine.

Clinical characteristics.

Indications.

Periodic insomnia in adults.

Contraindications.

Hypersensitivity to doxylamine succinate, excipients, or other antihistamines.

History of acute angle-closure glaucoma in the patient or family history.

Urethroprostatic disorders with risk of urinary retention.

Interaction with other medicinal products and other forms of interaction.

Combinations to be avoided.

Alcohol enhances the sedative effect of most H1-antihistamines. Consumption of alcoholic beverages and medicinal products containing ethanol should be avoided.

Concomitant use with sodium oxybate should be avoided due to increased central nervous system (CNS) depression. Impaired reaction speed may pose a danger when driving or operating machinery.

Combinations requiring caution.

• With atropine and atropine-like medicinal products (tricyclic antidepressants, most anticholinergic H1-antihistamines, anticholinergic antiparkinsonian agents, atropine-like spasmolytics, disopyramide, phenothiazine neuroleptics, as well as clozapine) — increased risk of adverse effects such as urinary retention, constipation, dry mouth.
• With other sedative medicinal products (morphine derivatives (analgesics, antitussives, substitution therapy), neuroleptics; barbiturates, benzodiazepines; anxiolytics other than benzodiazepines (meprobamate); other hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine); sedative H1-antihistamines; centrally acting antihypertensives; others: baclofen, thalidomide) — enhanced central nervous system (CNS) depression. Impaired reaction speed may pose a danger when driving or operating machinery.
• With other hypnotic agents — central nervous system (CNS) depression.

Special precautions for use.

Insomnia may have various causes that do not necessarily require drug treatment; therefore, consultation with a physician is recommended before starting to use this medicinal product.

The medicinal product contains lactose and is therefore contraindicated in cases of hereditary galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency.

Like all hypnotics or sedatives, doxylamine succinate may exacerbate sleep apnea syndrome (increasing the number and duration of breathing pauses).

The risk of abuse and development of drug dependence is low. However, cases of abuse leading to drug dependence have been reported. Signs of abuse or dependence on the medicinal product must be carefully monitored. The duration of treatment should not exceed 5 days. The use of this medicinal product is not recommended in patients with a history of disorders related to psychoactive substance use.

Doxylamine succinate remains in the body for approximately 5 elimination half-lives.

The elimination half-life may be significantly prolonged in elderly individuals or in patients with renal or hepatic impairment. With repeated administration, the drug or its metabolites reach steady-state concentrations much later and at higher levels. The efficacy and safety of the medicinal product can only be assessed after steady-state concentrations have been achieved.

Dosage adjustment may be required (see section "Dosage and administration").

H1-antihistamines should be used with caution in elderly patients due to the risk of cognitive disorders, sedative effects, slowed reaction time, and/or vertigo/dizziness, which increases the risk of falls (e.g., when getting up at night), potentially leading to serious consequences in this patient group.

In elderly patients with renal or hepatic impairment, increased plasma concentrations of the drug and reduced plasma clearance are observed. A reduced dose of the medicinal product is recommended.

To prevent daytime drowsiness, it is important to remember that the duration of sleep after taking the drug should be at least 7 hours.

If a patient has known sugar intolerances, medical advice should be sought before using this medicinal product.

Use during pregnancy or breastfeeding.

Based on available data, doxylamine may be used during pregnancy after consultation with a physician. If this medicinal product is used in late pregnancy, the anticholinergic and sedative effects of doxylamine should be taken into account when monitoring the newborn.

It is unknown whether doxylamine passes into breast milk; therefore, the use of this medicinal product is not recommended during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The risk of daytime drowsiness should be considered, particularly in individuals who drive or operate machinery, as such drowsiness may occur after taking this medicinal product. The risk of impaired reaction speed is increased if sleep duration is insufficient.

See also section "Interaction with other medicinal products and other forms of interaction."

Dosage and Administration.

For oral use. Take 15–30 minutes before bedtime.

The recommended dose is 7.5–15 mg per day (1/2–1 tablet per day). If necessary, the dose may be increased to 30 mg per day (2 tablets per day).

For elderly patients and patients with renal or hepatic impairment, a reduced dose is recommended.

The duration of treatment is 2–5 days.

If insomnia persists for longer than 5 days, a physician should be consulted regarding the appropriateness of continuing treatment.

Children.

The medicinal product must not be used in children (under 18 years of age).

Overdose.

The initial signs of acute poisoning include drowsiness and anticholinergic effects: excitation, dilated pupils, accommodation paralysis, dry mouth, facial and neck flushing, hyperthermia, and sinus tachycardia. Delirium, hallucinations, and athetoid movements are more commonly observed in children; sometimes they precede seizures—rare complications of massive poisoning—or even coma. Even in the absence of seizures, acute poisoning with doxylamine may occasionally cause rhabdomyolysis, which can lead to acute renal failure. Such muscle disorder is relatively common, necessitating systematic screening by measuring creatine phosphokinase activity.

Treatment is symptomatic. In early management, activated charcoal is recommended (50 g for adults, 1 g/kg for children).

Side effects

Anticholinergic effects: constipation, urinary retention, dry mouth, visual disturbances (accommodation disorder, blurred vision, hallucinations, visual defects), tachycardia, confusion.

Daytime drowsiness: if this effect occurs, the dose should be reduced.

Cases of drug abuse and development of drug dependence have been reported.

In addition, it is known that H1-antihistamine medicinal products may cause sedative effects, cognitive disorders, and psychomotor impairment.

Reporting of side effects

Reporting of suspected side effects after marketing authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 10 tablets in a blister pack; 3 blisters per carton.

Prescription status. Prescription only.

Manufacturer.

Limited Liability Company "Kharkiv Pharmaceutical Enterprise "Zdorovya Narodu".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's address and location of business activity.

Ukraine, 61002, Kharkiv region, city of Kharkiv, Kuilikivska Street, 41.

(Limited Liability Company "Kharkiv Pharmaceutical Enterprise "Zdorovya Narodu")

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, 100.

(Limited Liability Company "FARMEKS GROUP")