Dimdazenil(地达西尼胶囊)

Introduction of Dimdazenil

Dimdazenil Capsules is the world’s only selective partial agonist of the GABAA receptor for the treatment of insomnia, and also the first novel sedative-hypnotic chemical drug to be marketed in China in 16 years. It was approved for marketing by the National Medical Products Administration (NMPA) in November 2023.

Indications

Dimdazenil Capsules is indicated for the short-term treatment of patients with insomnia.

Overview

Dosage and Administration

This product is administered orally before bedtime at a dose of 2.5mg per time.

The treatment duration with this product is generally not more than 4 weeks, including the dose tapering period. Since the risks of abuse and dependence increase with the prolongation of treatment duration, the treatment duration should not be extended beyond 4 weeks without a reassessment of the patient's condition.

Patients with Hepatic Impairment

No dosage adjustment is required based on hepatic function for patients with mild hepatic impairment. No clinical study data is available for patients with moderate and severe hepatic impairment to date. Patients with hepatic impairment should conduct regular hepatic function tests during the administration of this product, and medical attention should be sought promptly if any abnormalities are observed.

Patients with Renal Impairment

No dosage adjustment is required based on renal function for patients with mild renal impairment. No clinical study data is available for patients with moderate and severe renal impairment to date. Patients with renal impairment should conduct regular renal function tests during the administration of this product, and medical attention should be sought promptly if any abnormalities are observed.

The safety and efficacy of this product in pediatric and adolescent patients under 18 years of age and geriatric patients over 65 years of age have not been established.

Contraindications

Dimdazenil is contraindicated in the following cases:

1、Patients with hypersensitivity to Dimdazenil or any other ingredients of this product.

2、Patients with myasthenia gravis.

3、Patients with severe sleep apnea syndrome.

4、Patients with severe respiratory insufficiency.

5、Patients who have experienced complex sleep behaviors after taking this product.

Adverse Reactions

General disorders and administration site conditions

Common: Fatigue, nervousness, lassitude, chest discomfort

Uncommon: Gait disturbance, bradyphrenia, thirst, hangover, swelling

Nervous system disorders

Very common: Dizziness

Common: Headache, Restless Legs Syndrome, periodic limb movement disorder, hyperesthesia, impaired memory, dysosmia

Uncommon: Somnolence, tremor, hypersomnia, head discomfort, involuntary muscle contractions, hypoesthesia, memory impairment, balance disorder, amnesia, hypoalgesia, sensory disturbance, cognitive disorder, sleep paralysis, dysgeusia, hypotonia

Psychiatric disorders

Common: Hallucinations

Uncommon: Anxiety, mood depression, illusions, dysphoria, feelings of hopelessness, depression, irritability, tension, sleep disorder

Respiratory, thoracic and mediastinal disorders

Common: Sleep apnea syndrome

Uncommon: Dyspnea, abnormal respiration

Cardiac disorders

Uncommon: Sinus bradycardia, ventricular extrasystoles, palpitations, sinus tachycardia, sinus arrhythmia, atrial tachycardia, myocardial ischemia

Gastrointestinal disorders

Common: Nausea, halitosis

Uncommon: Abdominal distension, xerostomia, epigastric pain, hiccups, retching, oral paresthesia, vomiting, dyschezia, hyposalivation, toothache

Vascular disorders

Uncommon: Hot flushes, hypertension

Renal and urinary disorders

Uncommon: Urinary tract bleeding, renal impairment, hematuria

Special Populations

Pregnancy and Lactation

No evidence is available to support the use of this product in pregnant and lactating women.

Pregnancy

This product can cross the placental barrier, and its use is not recommended during pregnancy.

Epidemiological case-control studies have shown that the incidence rate of neonatal cleft lip and palate (less than 2 per 1000) in infants exposed to benzodiazepines is higher than the expected incidence rate in the general population (1 per 1000). In addition, infants born to mothers who have used sedative/hypnotic drugs for a long time in the third trimester of pregnancy may develop physical dependence and may experience withdrawal symptoms after birth.

In light of the above data, the use of this product is not recommended during pregnancy.

If a woman of childbearing age who has been prescribed this product plans to become pregnant or suspects pregnancy, she should be advised to discontinue the product promptly and consult a physician.

Lactating Women

This product can cross the blood-milk barrier, and its use is not recommended during breastfeeding.

Pediatric Use

The safety and efficacy of this product in pediatric and adolescent patients under 18 years of age have not been established.

Geriatric Use

The safety and efficacy of this product in geriatric patients over 65 years of age have not been established.

For more detailed drug information, please consult the official package leaflet.

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