SONNIKS®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SONNIKS® (SONNIKS®)

Composition:

Active substance: doxylamine hydrogen succinate;

One tablet contains doxylamine hydrogen succinate 15 mg;

Excipients: lactose monohydrate; sodium croscarmellose; microcrystalline cellulose; magnesium stearate;

Coating SeleCoat™ AQ-02003 white: hypromellose, polyethylene glycol 6000, titanium dioxide (E171).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: round, biconvex tablets with a score line, coated with a film coating of white or almost white color.

Pharmacotherapeutic group

Antihistamines for systemic use. ATC code R06AA09.

Hypnotics and sedatives. ATC code N05CM.

Pharmacological Properties

Pharmacodynamics

Doxylamine succinate is an H1-histamine receptor antagonist of the ethanolamine class, exhibiting sedative and atropine-like effects. It has been demonstrated 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 average elimination half-life from plasma (T½) is approximately 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 or 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 the urine as unchanged doxylamine.

Clinical Characteristics

Indications

Intermittent insomnia in adults.

Contraindications

Hypersensitivity to doxylamine succinate or to any of the excipients of the medicinal product, or to other antihistamines.

Acute angle-closure glaucoma in the patient's medical history 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 enhanced central nervous system (CNS) depression. Impaired reaction speed may increase the risk when driving or operating machinery.

Combinations to be taken into consideration

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), due to the potential occurrence of adverse reactions such as urinary retention, constipation, and dry mouth.

With other sedative medicinal products (morphine derivatives (analgesics, antitussives, substitution therapy agents), 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), due to enhanced central nervous system (CNS) depression. Impaired reaction speed may increase the risk when driving or operating machinery.

With other hypnotic agents due to central nervous system (CNS) depression.

Special precautions for use

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

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

Like all hypnotic or sedative agents, doxylamine succinate may exacerbate obstructive 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. Treatment duration should not exceed 5 days. The medicinal product is not recommended for patients with a history of disorders related to psychoactive substance use.

Doxylamine succinate remains in the body for approximately 5 elimination half-lives (see section "Pharmacokinetics").

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 evaluated after steady-state concentrations have been achieved.

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

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 may increase the risk of falls (e.g., when getting up at night), with consequences that are often serious in this patient population.

In elderly patients with renal or hepatic impairment, increased plasma concentrations of the drug and reduced plasma clearance have been observed. Dose reduction of the medicinal product is recommended.

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

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 (atropine-like) and sedative properties of this molecule should be taken into account when monitoring the newborn.

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

Ability to influence reaction speed when driving or operating machinery

Caution should be exercised regarding the risk of daytime drowsiness, particularly in individuals who drive or operate machinery, which may occur following administration of this medicinal product. The risk of impaired reaction speed is increased when sleep duration is insufficient.

See 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 (½–1 tablet per day). If necessary, the dose may be increased to 30 mg per day (2 tablets per day).

Elderly patients and patients with renal or hepatic impairment should be given a reduced dose.

The duration of treatment is 2–5 days.

If insomnia persists for more than 5 days, consult a physician regarding the appropriateness of continuing the medication.

Children

The medication 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; these may sometimes precede seizures—a rare complication of severe poisoning—or even coma. Even in the absence of seizures, acute doxylamine poisoning may occasionally cause rhabdomyolysis, which can lead to acute renal failure. This muscular disorder is relatively common and requires 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).

Adverse Reactions

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 produce sedative effects, cognitive disorders, and psychomotor impairment.

Reporting of suspected adverse reactions

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

Shelf life: 3 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; 1 or 3 blisters per cardboard box.

Release category

№ 10 – over-the-counter.

№ 30 – prescription only.

Manufacturer

ASTRAFARM LLC.

Manufacturer's address and location of business activity

6, Kyivska Street, Vyshneve, Buchanskyi district, Kyiv region, 08132, Ukraine.