Zolpidem Domina
(Film Coated Tablets)

Composition:
Each film coated tablet contains 5 or 10mg Zolpidem Hemitartarate.

Mechanism of Action:
Zolpidem Domina is a non-benzodiazepine with the structure of an imidazopyridine group. Although it is not a benzodiazepine, it acts on the benzodiazepine receptor (W-1 subtype). It has a minimal effect on sleep stages and therefore is reputed to promote a more natural sleep. Advantages over the benzodiazepines include lack of withdrawal effect, no rebound insomnia and little or no tolerance demonstrated. It has a rapid onset of action and is useful for both initiating and maintaining sleep.

Indications:         
Zolpidem Domina is used for short term treatment of insomnia, where the insomnia is debilitating or is causing severe distress to the patient.

Dosage:
Zolpidem Domina acts rapidly and therefore should be taken immediately before retiring, or in bed.
Children: It should not be used in children.
Adults: The recommended daily dose is 10mg.
Adults under 65 years: Dosage may be increased to 10mg only where
the clinical response is inadequate and the drug is well tolerated.
Elderly or debilitated patients: May be especially sensitive to the
effects of the drug, therefore a 5mg dose is recommended.
Hepatic and renal impairment: Dosage should begin at 5mg with
particular caution in elderly patients.
The duration of treatment should usually vary from a few days to 2 weeks with a maximum of four weeks including tapering off where clinically appropriate.
As with all hypnotics, long term use is not recommended and a course of treatment should not exceed four weeks.

Side Effects:
It may cause: Nightmares, agitation, headache, gastrointestinal upset, dizziness, and daytime drowsiness.

Contraindications:
the drug should not be used in cases of: Obstructive sleep apnea, acute pulmonary insufficiency, respiratory depression, myasthenia gravis, severe hepatic impairment, psychotic illness.

Drug Interactions:

  1. Concomitant intake with alcohol may enhance the sedative effect.
  2. Combination with CNS depressants, anti-psychotics, hypnotics, anxiolytics, sedatives, narcotic analgesics, anti-epileptic drugs, anesthetics and sedative antihistamines may enhance the central depressive effect.
  3. In case of narcotic analgesics, enhancement of euphoria may also occur leading to an increase in psychological dependence.
  4. Compounds which inhibit certain hepatic enzymes (Particularly P450) may enhance the activity of drug.

Precautions:
The drug should be administered with caution in patients exhibiting symptoms of depression. Patients with history of drug or alcohol use, these patients should be under careful surveillance. The risk of dependence increases with dose and duration of treatment, it is also greater in patients with a history of alcohol or drug abuse. It is recommended that the dosage is decreased gradually to prevent the possible of rebound phenomena. Reactions like restlessness, agitation, irritability, aggressiveness, these reactions are more likely to occur in the elderly, the administration of the product should be discontinued.
Vehicle drivers and machine operators should be warned of risk of drowsiness in the morning after therapy.

Use in Pregnancy or Lactation:
Category C (risk cannot be ruled out). The drug is not recommended in nursing mothers.

Pharmacokinetics:
Zolpidem Domina has both a rapid absorption and onset of hypnotic action. Therapeutic dose is reached between 0.5–3 hours. All metabolites are pharmacologically inactive.

Presentation:
Carton pack contains 2 blisters of 10 film coated tablets in each, with leaflet.

 

 

 
 
 

© 2010 Domina Pharmaceuticals