Sonata^® Adamed (Capsules) Instructions for Use

Marketing Authorization Holder

Adamed Pharma, S.A. (Poland)

Manufactured By

Adamed Pharma, S.A. (Poland)

ATC Code

N05CF03 (Zaleplon)

Active Substance

Zaleplon (Rec.INN registered by WHO)

Dosage Form

Sonata® Adamed

Capsules 10 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Capsules hard, gelatin, size No. 3, with a pink body and a blue cap; the capsule contents are a white or almost white powder.

Excipients: microcrystalline cellulose – 72 mg, lactose monohydrate – 71.01 mg, colloidal silicon dioxide – 0.85 mg, sodium lauryl sulfate – 6.8 mg, sodium carboxymethyl starch – 8.5 mg, magnesium stearate – 0.85 mg.

Excipients (capsule No. 3) – body colorant iron oxide black – 0.03%, colorant azorubine – 0.0429%, colorant iron oxide red – 0.16%, titanium dioxide – 2.3333%, gelatin – up to 100%.
Excipients (capsule No. 3) – cap colorant indigotine – 0.0471 %, titanium dioxide – 1%, gelatin – up to 100%.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Hypnotic drug

Pharmacotherapeutic Group

Hypnotic agent

Pharmacological Action

A pyrazolopyrimidine-type hypnotic agent, which differs in chemical structure from benzodiazepines and other hypnotic drugs. It exhibits high selectivity and low affinity for benzodiazepine receptors of type 1.

It also has sedative, anxiolytic, muscle relaxant, and anticonvulsant effects.

Pharmacokinetics

After oral administration, absorption is about 71%. Plasma concentration is directly proportional to the dose. C_max in plasma is reached within 1 hour. Due to presystemic metabolism, the absolute bioavailability is about 30%. Plasma protein binding is about 60%. It is excreted in breast milk.

It is metabolized to form a number of inactive metabolites.

No accumulation is observed with a daily dose of up to 30 mg.

T_1/2 of zaleplon is about 1 hour.

It is excreted as metabolites in the urine – 71% and in the feces – 17%.

Indications

Severe sleep disorders with difficulty falling asleep.

ICD codes

Dosage Regimen

Take zaleplon orally immediately before bedtime only if you have difficulty falling asleep.

Do not take a second dose during the same night.

The standard single dose is 10 mg once daily.

Do not exceed the maximum daily dose of 10 mg.

For elderly patients, initiate therapy at a reduced dose of 5 mg once daily.

The total duration of treatment should not exceed 2 weeks without clinical reassessment.

Re-evaluate the diagnosis if sleep does not improve after a short course of therapy.

Ensure you have at least 4 hours of uninterrupted sleep after taking the dose to minimize the risk of psychomotor impairment and anterograde amnesia.

Discontinue treatment if you experience paradoxical reactions such as agitation, aggressiveness, hallucinations, or behavioral changes.

Be aware of the potential for developing tolerance and physical or mental dependence, especially with prolonged use or higher doses.

Avoid abrupt discontinuation after prolonged use due to the risk of withdrawal symptoms.

Exercise extreme caution when driving or operating machinery, as zaleplon significantly impairs these abilities.

Adverse Reactions

From the central nervous system often – headache, weakness, drowsiness, dizziness; possible anterograde amnesia (especially when taken in high doses), accompanied by behavioral disorders, symptoms of latent depression, physical and mental dependence, drug abuse; predominantly in elderly patients – paradoxical reactions (anxiety, agitation, irritability, aggressiveness, hallucinations, perception disorders, outbursts of anger, nightmares, behavioral disorders).

Contraindications

Severe hepatic insufficiency, sleep apnea syndrome, severe respiratory failure, severe myasthenia, lactation period, children and adolescents under 18 years of age, hypersensitivity to zaleplon.

Use in Pregnancy and Lactation

No safe and strictly controlled studies on the safety of zaleplon during pregnancy have been conducted, so its use is not recommended.

Women of childbearing age using Zaleplon should inform their doctor about a planned or established pregnancy.

If it is necessary to use zaleplon in the third trimester of pregnancy or use in high doses during childbirth, the possibility of developing hypothermia, hypotension, and moderate respiratory failure in the newborn should be considered.

Zaleplon is excreted in breast milk, so its use during lactation is contraindicated.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

In mild to moderate renal impairment, dose adjustment is not required. There are no data on the safety of zaleplon use in severe renal impairment.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Zaleplon can be used in elderly patients, including those over 75 years of age.

Special Precautions

Use with particular caution in patients with chronic respiratory failure, and in the presence of alcohol and drug dependence.

It is not recommended to use Zaleplon as a primary medication for psychoses.

Zaleplon is not intended for the treatment of depression and associated conditions of increased anxiety, as it can provoke suicide attempts. If it is necessary to use it in patients with depression, Zaleplon should be used at the minimum effective dose to avoid intentional overdose.

If sleep does not normalize after short-term use of zaleplon or if the sleep disorder progresses, the diagnosis should be reconsidered.

The need to use zaleplon for more than 2 weeks is determined individually after a clinical examination of the patient.

In mild to moderate renal impairment, dose adjustment is not required. There are no data on the safety of zaleplon use in severe renal impairment.

After several weeks of treatment, the development of tolerance and a decrease in the effectiveness of zaleplon are possible.

The development of physical and mental dependence is possible, the likelihood of which is associated with taking zaleplon in high doses, long-term use, and the presence of alcohol and drug dependence.

In case of established physical dependence, abrupt withdrawal of the drug leads to the development of withdrawal symptoms: headache, myalgia, severe anxiety, increased tension, restlessness, irritability, confusion. In severe cases, auto-aggression, depersonalization, hearing loss, paresthesia in the limbs, increased reaction to light, sound, and physical stimuli, hallucinations, and epileptic seizures are possible.

After discontinuation of treatment, transient manifestations of insomnia are possible, but in a more pronounced form. In this case, the development of concomitant symptoms, such as mood disorders, feelings of increased anxiety, and restlessness, is possible.

Several hours after taking zaleplon, the development of anterograde amnesia and psychomotor function disorders is possible. To avoid the development of these symptoms, Zaleplon should be taken only if the patient has the opportunity for uninterrupted sleep for at least the first 4 hours after taking zaleplon.

Treatment with zaleplon should be discontinued if increased feelings of restlessness, agitation, irritability, aggressiveness, perception disorders, fits of anger, nightmares, hallucinations, and especially behavioral disorders appear. Elderly patients are most prone to developing such symptoms.

Zaleplon can be used in elderly patients, including those over 75 years of age.

Effect on the ability to drive vehicles and operate machinery

It has a negative impact on the ability to drive a car. During the treatment period, extreme caution should be exercised when engaging in potentially hazardous activities that require concentration and high speed of psychomotor reactions.

Drug Interactions

With simultaneous use of antipsychotics, hypnotics, anxiolytics, antidepressants, antiepileptics, anesthetics, histamine H₁-receptor blockers with sedative effect, opioid analgesics, and ethanol, the sedative effect of zaleplon is enhanced.

With simultaneous use of zaleplon and opioid analgesics, euphoria may occur, which leads to the development of dependence.

Cimetidine, which is a non-specific inhibitor of liver enzymes (aldehyde oxidase and CYP3A4), increases the plasma concentration of zaleplon by 85% (the combination should be used with caution).

Selective CYP3A4 blockers (including ketoconazole, erythromycin) increase the plasma concentration of zaleplon, and an enhancement of the sedative effect of zaleplon is possible (dose adjustment is not required).

Strong CYP3A4 inducers, such as rifampicin, carbamazepine, phenobarbital derivatives, can reduce the plasma concentration of zaleplon and its effect by 25%.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.