Zolpidem Tartrate (Zolpitaj) Tablet -10 mg Taj Pharma

  1. Name of the medicinal product

Zolpidem Tartrate (Zolpitaj) 10 mg film-coated Tablets

  1. Qualitative and quantitative composition

Containing 10 mg zolpidem tartrate.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Coated tablets for oral administration.

  1. Clinical particulars

4.1 Therapeutic indications

Zolpidem Tartrate (Zolpitaj) is indicated for the short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.

4.2 Posology and method of administration

Posology

The treatment should be taken in a single intake and not be re-administered during the same night.

The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. The lowest effective daily dose of zolpidem tartrate should be used and must not exceed 10 mg.

The duration of treatment should usually vary from a few days to two weeks with a maximum of four weeks including tapering off where clinically appropriate.

Treatment should be as short as possible. It should not exceed four weeks including the period of tapering off. In certain cases extension beyond the maximum treatment period may be necessary; if so, extension beyond the maximum treatment period should not take place without re-evaluation of the patient’s status, since the risk of abuse and dependence increases with the duration of treatment (see section 4.4).

Special populations

Paediatric population

Zolpidem Tartrate (Zolpitaj) is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group. The available evidence from placebo-controlled clinical trials is presented in section 5.1.

Elderly

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate therefore a 5 mg dose is recommended. These recommended doses should not be exceeded.

Hepatic impairment

As clearance and metabolism of zolpidem tartrate is reduced in hepatic impairment, dosage should begin at 5 mg in these patients with particular caution being exercised in elderly patients. In adults (under 65 years) dosage may be increased to 10 mg only where the clinical response is inadequate and the drug is well tolerated.

Zolpidem must not be used in patients with severe hepatic impairment as it may contribute to encephalopathy (see section 4.3).

Method of administration

Oral administration.

4.3 Contraindications

  • Zolpidem tartrate is contraindicated in patients with a hypersensitivity to zolpidem tartrate or any of the excipients listed in section 6.1.
  • Obstructive sleep apnoea.
  • Myasthenia gravis.
  • Severe hepatic insufficiency.
  • Acute and/or severe respiratory depression.

In the absence of data, zolpidem tartrate should not be prescribed for children or patients with psychotic illness.

4.4 Special warnings and precautions for use

The cause of insomnia should be identified wherever possible and the underlying factors treated before a hypnotic is prescribed. The failure of insomnia to remit after a 7 – 14 day course of treatment may indicate the presence of a primary psychiatric or physical disorder, and the patient should be carefully re-evaluated at regular intervals.

Next-day psychomotor impairment

Like other sedative/hypnotic drugs, Zolpidem Tartrate (Zolpitaj) has CNS-depressant effects. The risk of next-day psychomotor impairment, including impaired driving ability, is increased if:

  • zolpidem tartrate is taken within less than 8 hours before performing activities that require mental alertness (see section 4.7);
  • a dose higher than the recommended dose is taken;
  • zolpidem tartrate is co-administered with other CNS depressants or with other drugs that increase the blood levels of zolpidem tartrate, or with alcohol or illicit drugs (see section 4.5).

Zolpidem tartrate should be taken in a single intake immediately at bedtime and not be re-administered during the same night.

Specific patient groups

Respiratory insufficiency:

As hypnotics have the capacity to depress respiratory drive, precautions should be observed if Zolpidem Tartrate (Zolpitaj) is prescribed to patients with compromised respiratory function.

Hepatic insufficiency:

See section 4.2.

Elderly:

See section 4.2 for dose recommendations.

Risk from concomitant use of opioids:

Concomitant use of Zolpidem Tartrate (Zolpitaj) and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Zolpidem Tartrate (Zolpitaj) with opioids should be reserved for patients for whom alternative treatment options are not possible.

If a decision is made to prescribe Zolpidem Tartrate (Zolpitaj) concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their environment to be aware of these symptoms (see section 4.5).

Use in patients with a history of drug or alcohol abuse:

Extreme caution should be exercised when prescribing for patients with a history of drug or alcohol abuse. These patients should be under careful surveillance when receiving zolpidem tartrate or any other hypnotic, since they are at risk of habituation and psychological dependence.

Psychotic illness:

Hypnotics such as Zolpidem Tartrate (Zolpitaj) are not recommended for the primary treatment of psychotic illness.

Suicidal ideation, suicide attempt, suicide and depression:

Some epidemiological studies suggest an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zolpidem. However, a causal relationship has not been established.

As with other sedative/hypnotic drugs, zolpidem tartrate should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present therefore the least amount of Zolpidem Tartrate (Zolpitaj) that is feasible should be supplied to these patients to avoid the possibility of intentional overdose by the patient. Pre-existing depression may be unmasked during use of Zolpidem Tartrate (Zolpitaj). Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists.

General information relating to effects seen following administration of benzodiazepines and other hypnotic agents which should be taken into account by the prescribing physician are described below.

Tolerance:

Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents like Zolpidem Tartrate (Zolpitaj) may develop after repeated use for a few weeks.

Dependence:

Use of zolpidem may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence increases with dose and duration of treatment. The risk of abuse and dependence is also greater in patients with a history of psychiatric disorders and/or alcohol, substance or drug abuse. Zolpidem should be used with extreme caution in patients with current or a history of alcohol, substance or drug abuse or dependence.

If physical dependence is developed, a sudden discontinuation of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

Rebound insomnia:

A transient syndrome whereby the symptoms that led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form may occur on withdrawal of hypnotic treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness.

It is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur when the medicinal product is discontinued. Since the risk of withdrawal phenomena or rebound has been shown to be greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually where clinically appropriate.

There are indications that, in the case of benzodiazepines and benzodiazepine-like agents with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.

Amnesia:

Benzodiazepines or benzodiazepine-like agents such as Zolpidem Tartrate (Zolpitaj) may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product. In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see section 4.8).

Other psychiatric and “paradoxical” reactions:

Other psychiatric and paradoxical reactions like restlessness, exacerbated insomnia, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, abnormal behaviour and other adverse behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents. Should this occur, use of the product should be discontinued. These reactions are more likely to occur in the elderly.

Somnambulism and associated behaviours:

Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, making phone calls or having sex, with amnesia for the event, have been reported in patients who had taken Zolpidem Tartrate (Zolpitaj) and were not fully awake. The use of alcohol and other CNS-depressants with Zolpidem Tartrate (Zolpitaj) appears to increase the risk of such behaviours, as does the use of Zolpidem Tartrate (Zolpitaj) at doses exceeding the maximum recommended dose. Discontinuation of Zolpidem Tartrate (Zolpitaj) should be strongly considered for patients who report such behaviours (for example, sleep driving), due to the risk to the patient and others (see sections 4.5 and 4.8).

Severe injuries:

Due to its pharmacological properties, zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries.

4.5 Interaction with other medicinal products and other forms of interaction

Not recommended

Concomitant intake with alcohol:

The sedative effect may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines.

Take into account

Combination with CNS depressants:

Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines. Therefore, concomitant use of Zolpidem Tartrate (Zolpitaj) with these drugs may increase drowsiness and next-day psychomotor impairment, including impaired driving ability (see sections 4.4 and 4.7). Also, isolated cases of visual hallucinations were reported in patients taking Zolpidem Tartrate (Zolpitaj) with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine.

Co-administration of fluvoxamine may increase blood levels of zolpidem tartrate, concurrent use is not recommended.

In the case of narcotic analgesics enhancement of euphoria may also occur leading to an increase in psychological dependence.

Opioids:

The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Zolpidem Tartrate (Zolpitaj) with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see section 4.4).

CYP450 inhibitors and inducers:

Co-administration of ciprofloxacin may increase blood levels of zolpidem tartrate, concurrent use is not recommended.

Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines and benzodiazepine-like agents.

Zolpidem tartrate is metabolised via several hepatic cytochrome P450 enzymes, the main enzyme being CYP3A4 with the contribution of CYP1A2. The pharmacodynamic effect of zolpidem tartrate is decreased when it is administered with a CYP3A4 inducer such as rifampicin and St. John’s Wort. St. John’s Wort has been shown to have a pharmacokinetic interaction with zolpidem. Mean Cmax and AUC were decreased (33.7 and 30.0% lower, respectively) for zolpidem administered with St. John’s Wort compared to zolpidem administered alone. Co-administration of St. John’s Wort may decrease blood levels of zolpidem, concurrent use is not recommended.

However when zolpidem tartrate was administered with itraconazole (a CYP3A4 inhibitor) its pharmacokinetics and pharmacodynamics were not significantly modified. The clinical relevance of these results is unknown.Co-administration of Zolpidem Tartrate (Zolpitaj) with ketoconazole (200 mg twice daily), a potent CYP3A4 inhibitor, prolonged Zolpidem Tartrate (Zolpitaj) elimination half-life, increased total AUC, and decreased apparent oral clearance when compared to Zolpidem Tartrate (Zolpitaj) plus placebo. The total AUC for Zolpidem Tartrate (Zolpitaj), when co-administered with ketoconazole, increased by a factor of 1.83 when compared to Zolpidem Tartrate (Zolpitaj) alone. A routine dosage adjustment of Zolpidem Tartrate (Zolpitaj) is not considered necessary, but patients, should be advised that use of Zolpidem Tartrate (Zolpitaj) with ketoconazole may enhance the sedative effects.

Since CYP3A4 plays an important role in zolpidem tartrate metabolism, possible interactions with drugs that are substrates or inducers of CYP3A4 should be considered.

Other drugs:

When zolpidem tartrate was administered with ranitidine, no significant pharmacokinetic interactions were observed.

4.6 Fertility, pregnancy and lactation

Pregnancy

The use of zolpidem is not recommended during pregnancy.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Zolpidem crosses the placenta.

A large amount of data on pregnant women (more than 1000 pregnancy outcomes) collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines or benzodiazepine-like substances during the first trimester of pregnancy. However, certain case-control studies reported an increased incidence of cleft lip and palate associated with use of benzodiazepines during pregnancy.

Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines or benzodiazepine-like substances during the second and/or third trimester of pregnancy.

Administration of zolpidem during the late phase of pregnancy or during labour has been associated with effects on the neonate, such as hypothermia, hypotonia, feeding difficulties (‘floppy infant syndrome’) and respiratory depression due to the pharmacological action of the product. Cases of severe neonatal respiratory depression have been reported.

Moreover, infants born to mothers who took sedative/hypnotic agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended.

If Zolpidem Tartrate (Zolpitaj) is prescribed to a woman of childbearing potential, she should be warned to contact her physician about stopping the product if she intends to become or suspects that she is pregnant.

Breast-feeding

Small quantities of zolpidem tartrate appear in breast milk. The use of zolpidem tartrate in nursing mothers is therefore not recommended.

4.7 Effects on ability to drive and use machines

Zolpidem Tartrate (Zolpitaj) has major influence on the ability to drive and use machines.

Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision and reduced alertness and impaired driving the morning after therapy (see section 4.8). In order to minimise this risk a resting period of at least 8 hours is recommended between taking zolpidem tartrate and driving, using machinery and working at heights.

Driving ability impairment and behaviours such as ‘sleep-driving’ have occurred with zolpidem tartrate alone at therapeutic doses.

Furthermore, the co-administration of zolpidem tartrate with alcohol and other CNS depressants increases the risk of such behaviours (see sections 4.4 and 4.5). Patients should be warned not to use alcohol or other psychoactive substances when taking zolpidem tartrate.

4.8 Undesirable effects

The following CIOMS frequency rating is used, when applicable:

Very common ≥10%

Common ≥ 1 and < 10%

Uncommon ≥ 0.1 and < 1%

Rare ≥ 0.01 and < 0.1%

Very rare < 0.01%

Not known: cannot be estimated based on available data.

There is evidence of a dose-relationship for adverse effects associated with zolpidem tartrate use, particularly for certain CNS and gastrointestinal events. As recommended in section 4.2, they should in theory be less if zolpidem tartrate is taken immediately before retiring, or in bed. They occur most frequently in elderly patients.

Immune system disorders

Not known: angioneurotic oedema

Psychiatric disorders

Common: hallucination, agitation, nightmare, depression (see section 4.4)

Uncommon: confusional state, irritability, restlessness, aggression, somnambulism (see section 4.4), euphoric mood

Rare: libido disorder

Very rare: delusion, dependence (withdrawal symptoms, or rebound effects may occur after treatment discontinuation)

Not known: anger, psychosis, abnormal behavior

Most of these psychiatric undesirable effects are related to paradoxical reactions

Nervous system disorders

Common: somnolence, headache, dizziness, exacerbated insomnia, cognitive disorders such as anterograde amnesia (amnestic effects may be associated with inappropriate behaviour)

Uncommon: paraesthesia, tremor, disturbance in attention, speech disorder

Rare: depressed level of consciousness

Eye disorders

Uncommon: diplopia, vision blurred

Very rare: visual impairment

Respiratory, thoracic and mediastinal disorders

Very rare: respiratory depression (see section 4.4)

Gastro-intestinal disorders

Common: diarrhoea, nausea, vomiting, abdominal pain

Hepatobiliary disorders

Uncommon: liver enzymes elevated

Rare: hepatocellular, cholestatic or mixed liver injury (see sections 4.2, 4.3 and 4.4)

Metabolism and nutrition disorders

Uncommon: appetite disorder

Skin and subcutaneous tissue disorders

Uncommon: rash, pruritus, hyperhidrosis

Rare: urticaria

Musculoskeletal and connective tissue disorders

Common: back pain

Uncommon: myalgia, muscle spasmsmuscular weakness

Infections and infestations

Common: upper respiratory tract infection, lower respiratory tract infection

General disorders and administration site conditions

Common: fatigue

Rare: gait disturbance, fall (predominantly in elderly patients and when zolpidem was not taken in accordance with prescribing recommendation) (see section 4.4).

Not known: drug tolerance

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Signs and symptoms:

In cases of overdose involving zolpidem tartrate alone or with other CNS-depressant agents (including alcohol), impairment of consciousness ranging from somnolence to coma, and more severe symptomatology, including fatal outcomes have been reported.

Management:

General symptomatic and supportive measures should be used. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Sedating drugs should be withheld even if excitation occurs.

Use of flumazenil may be considered where serious symptoms are observed. Flumazenil is reported to have an elimination half-life of about 40 – 80 minutes. Patients should be kept under close observation because of this short duration of action; further doses of flumazenil may be necessary. However, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions).

Zolpidem is not dialyzable. The value of dialysis in the treatment of an overdose has not been determined. Dialysis in patients with renal failure receiving therapeutic doses of zolpidem have demonstrated no reduction in levels of zolpidem.

In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

(GABA-A receptor modulator selective for omega-1 receptor subtype hypnotic agent).

Zolpidem tartrate is an imidazopyridine which preferentially binds the omega-1 receptor subtype (also known as the benzodiazepine-1 subtype) which corresponds to GABA-A receptors containing the alpha-1 sub-unit, whereas benzodiazepines non-selectively bind both omega-1 and omega-2 subtypes. The modulation of the chloride anion channel via this receptor leads to the specific sedative effects demonstrated by zolpidem tartrate. These effects are reversed by the benzodiazepine antagonist flumazenil.

In animals: The selective binding of zolpidem tartrate to omega-1 receptors may explain the virtual absence at hypnotic doses of myorelaxant and anti-convulsant effects in animals which are normally exhibited by benzodiazepines which are not selective for omega-1 sites.

In man: zolpidem tartrate decreases sleep latency and the number of awakenings, and increases sleep duration and sleep quality. These effects are associated with a characteristic EEG profile, different from that of the benzodiazepines. In studies that measured the percentage of time spent in each sleep stage, zolpidem tartrate has generally been shown to preserve sleep stages. At the recommended dose, zolpidem tartrate has no influence on the paradoxical sleep duration (REM). The preservation of deep sleep (stages 3 and 4 – slow-wave sleep) may be explained by the selective omega-1 binding by zolpidem tartrate. All identified effects of zolpidem tartrate are reversed by the benzodiazepine antagonist flumazenil.

The randomized trials only showed convincing evidence of efficacy of 10 mg zolpidem tartrate.

In a randomized double-blind trial in 462 non-elderly healthy volunteers with transient insomnia, zolpidem tartrate 10 mg decreased the mean time to fall asleep by 10 minutes compared to placebo, while for 5 mg zolpidem tartrate this was 3 minutes.

In a randomized double-blind trial in 114 non-elderly patients with chronic insomnia, zolpidem tartrate 10 mg decreased the mean time to fall asleep by 30 minutes compared to placebo, while for 5 mg zolpidem tartrate this was 15 minutes.

In some patients, a lower dose of 5mg could be effective.

Paediatric population

Safety and efficacy of zolpidem tartrate have not been established in children aged less than 18 years. A randomized placebo-controlled study in 201 children aged 6 – 17 years with insomnia associated with Attention Deficit Hyperactivity Disorder (ADHD) failed to demonstrate efficacy of zolpidem tartrate 0.25 mg/kg/day (with a maximum of 10 mg/day) as compared to placebo. Psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse events observed with zolpidem tartrate versus placebo and included dizziness (23.5% versus 1.5%), headache (12.5% versus 9.2%), and hallucinations (7.4% versus 0%) (see sections 4.2 and 4.3).

5.2 Pharmacokinetic properties

Zolpidem tartrate has both a rapid absorption and onset of hypnotic action. Bioavailability is 70% following oral administration and demonstrates linear kinetics in the therapeutic dose range. Peak plasma concentration is reached at between 0.5 and 3 hours.

The elimination half-life is short, with a mean of 2.4 hours (± 0.2 h) and a duration of action of up to 6 hours.

Protein binding amounts to 92.5% ± 0.1%. First pass metabolism by the liver amounts to approximately 35%. Repeated administration has been shown not to modify protein binding indicating a lack of competition between zolpidem tartrate and its metabolites for binding sites.

The distribution volume in adults is 0.54 ± 0.02 L/kg and decreases to 0.34 ± 0.05 L/kg in the very elderly.

All metabolites are pharmacologically inactive and are eliminated in the urine (56%) and in the faeces (37%).

Zolpidem tartrate has been shown in trials to be non-dialysable.

Plasma concentrations in elderly subjects and those with hepatic impairment are increased. In patients with renal insufficiency, whether dialysed or not, there is a moderate reduction in clearance. The other pharmacokinetic parameters are unaffected.

Zolpidem tartrate is metabolised via several hepatic cytochrome P450 enzymes, the main enzyme being CYP3A4 with the contribution of CYP1A2. Since CYP3A4 plays an important role in zolpidem tartrate metabolism, possible interactions with drugs that are substrates or inducers of CYP3A4 should be considered.

5.3 Preclinical safety data

No data of therapeutic relevance.

  1. Pharmaceutical particulars

6.1 List of excipients

Tablet core: Lactose monohydrate, Microcrystalline cellulose, Hypromellose, Sodium starch glycollate. Magnesium stearate

Film coating: Hypromellose, Titanium dioxide, Macrogol.

6.2 Incompatibilities

None known

6.3 Shelf life

3 years.

6.4 Special precautions for storage

No special precautions

6.5 Nature and contents of container

Cartons of 4 or 28 tablets in PVC/foil blister strips.

6.6 Special precautions for disposal and other handling

Please consult the package insert before use. Do not use after the stated expiry date on the carton and blister.

KEEP OUT OF THE REACH OF CHILDREN

  1. Marketed By:
    Taj Pharmaceuticals Ltd.
    15-6-108 Afjal Gunj.
    Hyderabad TS 500012, India.

 

Zolpidem Tartrate (Zolpitaj) 10 mg film-coated Tablets

 

Package leaflet: Information for the user

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Zolpidem Tartrate (Zolpitaj) is and what it is used for
    2. What you need to know before you take Zolpidem Tartrate (Zolpitaj)
    3. How to take Zolpidem Tartrate (Zolpitaj)
    4. Possible side effects
    5. How to store Zolpidem Tartrate (Zolpitaj)
    6. Contents of the pack and other information
  2. What Zolpidem Tartrate (Zolpitaj) is and what it is used for

The name of your medicine is Zolpidem Tartrate (Zolpitaj) 10mg film-coated Tablets (called Zolpidem Tartrate (Zolpitaj) in this leaflet).

Zolpidem Tartrate (Zolpitaj) contains a medicine called zolpidem tartrate. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.

Zolpidem Tartrate (Zolpitaj) is used for temporary sleep problems in adults that are causing you severe distress or that are affecting your everyday life. This includes sleep problems in adults such as:

  • Difficulty falling asleep
  • Waking in the middle of the night
  • Waking too early

Your doctor will identify your sleep problem wherever possible and the underlying factors before prescribing this medicine for you. The failure of your sleep problems to stop after a 7-14 day course of treatment may indicate you have an underlying disorder, your doctor will assess you at regular intervals.

Zolpidem Tartrate (Zolpitaj) is used for short-term treatment of insomnia in adults. Do not use long-term. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment. Ask your doctor for advice if you are unsure.

  1. What you need to know before you take Zolpidem Tartrate (Zolpitaj)

Do not take Zolpidem Tartrate (Zolpitaj) if:

  • You are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of Zolpidem Tartrate (Zolpitaj) (listed in section 6).
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
  • Your lungs do not work properly (respiratory failure).
  • You have severe liver problems.
  • You have a problem where you stop breathing for short periods at night (sleep apnoea).
  • You have a problem that causes severe muscle weakness (myasthenia gravis).
  • You have been told by a doctor that you have a mental illness (psychosis).
  • You are under the age of 18.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Zolpidem Tartrate (Zolpitaj).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolpidem Tartrate (Zolpitaj) if:

  • You have a history of alcohol or drug abuse.
  • You have liver problems.
  • You have depression or have had another mental illness in the past.
  • You have recently taken Zolpidem Tartrate (Zolpitaj) or other similar medicines for more than four weeks.
  • You are elderly.

Use of Zolpidem Tartrate (Zolpitaj) may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence is greater when Zolpidem Tartrate (Zolpitaj) is used for longer than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substance or drug abuse. Tell your healthcare provider if you have ever had a mental disorder, or have abused or have been dependent on alcohol, substance or drugs.

Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.

Zolpidem Tartrate (Zolpitaj) can cause drowsiness and decrease your level of alertness. This could cause you to fall, sometimes leading to severe injuries.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Zolpidem Tartrate (Zolpitaj).

Next-day psychomotor impairment (see also ‘Driving and using machines’)

The day after taking Zolpidem Tartrate (Zolpitaj), the risk of psychomotor impairment, including impaired driving ability may be increased if:

  • You take this medicine less than 8 hours before performing activities that require your alertness.
  • You take a higher dose than the recommended dose.
  • You take Zolpidem Tartrate (Zolpitaj) while you are already taking other central nervous system depressants or another medicine that increases Zolpidem Tartrate (Zolpitaj) in your blood, or while drinking alcohol, or while taking illicit substances.

Take the single intake immediately at bedtime.

Do not take another dose during the same night.

Other medicines and Zolpidem Tartrate (Zolpitaj)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Zolpidem Tartrate (Zolpitaj) can affect the way some other medicines work. Also some medicines can affect the way Zolpidem Tartrate (Zolpitaj) works.

Zolpidem Tartrate (Zolpitaj) may increase the effect of the following medicines:

While taking Zolpidem Tartrate (Zolpitaj) with the following medicines, drowsiness and next-day psychomotor impairment effects, including impaired driving ability, may be increased.

  • Medicines for some mental health problems (antipsychotics).
  • Medicines for sleep problems (hypnotics).
  • Medicines to calm or reduce anxiety.
  • Medicines for depression.
  • Medicines for moderate to severe pain (narcotic analgesics).
  • Medicines for epilepsy (anti-convulsants).
  • Medicines used for anaesthesia.
  • Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines).

While taking Zolpidem Tartrate (Zolpitaj) with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not real (hallucinations).

It is not recommended to take Zolpidem Tartrate (Zolpitaj) with fluvoxamine, ciprofloxacin or St John’s Wort (a herbal medicine) used for mood swings and depression.

Risks from concomitant use with opioids

Concomitant use of Zolpidem Tartrate (Zolpitaj) and opioids (strong painkillers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Zolpidem Tartrate (Zolpitaj) together with opioids the dosage and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

The following medicines can increase the chance of you getting side effects when taken with Zolpidem Tartrate (Zolpitaj). To make this less likely, your doctor may decide to lower your dose of Zolpidem Tartrate (Zolpitaj):

  • Some antibiotics such as clarithromycin or erythromycin.
  • Some medicines for fungal infections such as ketoconazole and itraconazole.
  • Ritonavir (a protease inhibitor) – for HIV infections.

The following medicines can make Zolpidem Tartrate (Zolpitaj) work less well:

  • Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin.
  • Rifampicin (an antibiotic) – for infections.

Zolpidem Tartrate (Zolpitaj) with alcohol

Do not drink alcohol while you are taking Zolpidem Tartrate (Zolpitaj).

Alcohol can increase the effects of Zolpidem Tartrate (Zolpitaj) and make you sleep very deeply so that you do not breathe properly or have difficulty waking.

Pregnancy, breast-feeding and fertility

Pregnancy

Use of Zolpidem Tartrate (Zolpitaj) is not recommended during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice.

If used during pregnancy there is a risk that the baby is affected. Some studies have shown that there may be an increased risk of cleft lip and palate (sometimes called “harelip”) in the newborn baby.

Reduced fetal movement and fetal heart rate variability may occur after taking Zolpidem Tartrate (Zolpitaj) during the second and/or third trimester of pregnancy.

If Zolpidem Tartrate (Zolpitaj) is taken at the end of pregnancy or during labour, your baby may show muscle weakness, a drop in body temperature, difficulty feeding and breathing problems (respiratory depression).

If this medicine is taken regularly in late pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.

Breast-feeding

Do not take Zolpidem Tartrate (Zolpitaj) if you are breast-feeding or planning to breast-feed. This is because small amounts may pass into mothers’ milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Zolpidem Tartrate (Zolpitaj) has major influence on the ability to drive and use machines such as ‘sleep-driving’.

On the day after taking Zolpidem Tartrate (Zolpitaj) (as with other hypnotic medicines), you should be aware that:

  • You may feel drowsy, sleepy, dizzy or confused.
  • Your quick decision-making may be longer.
  • Your vision may be blurred or double.
  • You may be less alert.

A period of at least 8 hours is recommended between taking Zolpidem Tartrate (Zolpitaj) and driving, using machinery and working at heights to minimize the above listed effects.

Do not drink alcohol or take other psychoactive substances while you are taking Zolpidem Tartrate (Zolpitaj) as it can increase the above listed effects.

Zolpidem Tartrate (Zolpitaj) contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

  1. How to take Zolpidem Tartrate (Zolpitaj)

Always take Zolpidem Tartrate (Zolpitaj) exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

  • Take this medicine by mouth.
  • Swallow the tablet whole with a drink of water.
  • The recommended dose per 24 hours is 10mg of Zolpidem Tartrate (Zolpitaj). A lower dose may be prescribed to some patients.
  • Zolpidem Tartrate (Zolpitaj) should be taken as a single intake just before bedtime.
  • Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require your alertness.
  • Do not exceed 10mg per 24 hours.
  • The usual length of treatment is 2 days to 4 weeks.

How much to take

Adults

  • The usual dose is one Zolpidem Tartrate (Zolpitaj) tablet (10mg) just before bedtime.

Elderly

  • The usual dose is half a tablet (5mg) just before bedtime.

Patients with liver problems

  • The usual starting dose is half a tablet (5mg) just before bedtime. Your doctor may decide to increase this to one tablet (10mg) if it is safe to do so.

Children and adolescents

Zolpidem Tartrate (Zolpitaj) should not be used in people under 18 years old.

If you take more Zolpidem Tartrate (Zolpitaj) than you should

If you take more Zolpidem Tartrate (Zolpitaj) than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you.

This is so the doctor knows what you have taken.

Taking too much Zolpidem Tartrate (Zolpitaj) can be very dangerous.

The following effects may happen:

  • Feeling drowsy, confused, sleeping deeply and possibly falling into a fatal coma.

If you forget to take Zolpidem Tartrate (Zolpitaj)

Zolpidem Tartrate (Zolpitaj) must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Zolpidem Tartrate (Zolpitaj)

Keep taking Zolpidem Tartrate (Zolpitaj) until your doctor tells you to stop. Do not stop taking Zolpidem Tartrate (Zolpitaj) suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time. If you stop taking Zolpidem Tartrate (Zolpitaj) suddenly, your sleep problems may come back and you may get a ‘withdrawal effect’.

If this happens you may get some of the effects listed below.

See a doctor straight away if you get any of the following effects:

  • Feeling anxious, restless, irritable or confused
  • Headache
  • Faster heartbeat or uneven heartbeat (palpitations)
  • Nightmares, seeing or hearing things that are not real (hallucinations)
  • Being more sensitive to light, noise and touch than normal
  • Relaxed grip on reality
  • Feeling distant from your body or feeling ‘puppet-like’
  • Numbness and tingling in your hands and feet
  • Aching muscles
  • Stomach problems
  • Sleep problems come back worse than before
  • Fits (seizures)
  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Zolpidem Tartrate (Zolpitaj) and see a doctor or go to a hospital straight away if:

  • You have an allergic reaction. These signs may include: an itchy, lumpy rash (hives) or nettle rash (urticaria), swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing

Tell your doctor as soon as possible if you have any of the following side effects:

Common side effects (may affect less than 1 in 10 people)

  • Poor memory while taking Zolpidem Tartrate (Zolpitaj) (amnesia) and strange behaviour during this time. This is more likely to affect you in the few hours after you take this medicine. By having 7-8 hours sleep after taking Zolpidem Tartrate (Zolpitaj), this is less likely to cause you a problem
  • Sleeping problems that get worse after taking this medicine
  • Seeing or hearing things that are not real (hallucinations)

Uncommon side effects (may affect less than 1 in 100 people)

  • Blurred eyesight or ‘seeing double’

Rare side effects (may affect less than 1 in 1,000 people)

  • Being less aware of your environment
  • Falling, especially in the elderly

Sleep-driving and other sleep-related behaviour

There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleeping medicine.

This includes sleep-driving, sleepwalking, preparing and eating food, and having sex. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Common side effects (may affect less than 1 in 10 people)

  • Diarrhoea
  • Feeling sick (nausea) or being sick (vomiting)
  • Abdominal pain
  • Respiratory infection
  • Headache
  • Feeling tired or agitated
  • Nightmares
  • Depression
  • Feeling dizzy
  • Feeling drowsy or sleepy
  • Back pain

Uncommon side effects (may affect less than 1 in 100 people)

  • Itching skin or skin rash
  • Excessive sweating
  • Feeling restless, aggressive, confused or irritable
  • Feeling overly happy/confident (euphoric)
  • Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
  • Tremor
  • Sleepwalking (see ‘Sleep-driving and other sleep-related behaviour’)
  • Lack of concentration
  • Speech problems
  • Blurred vision
  • Changes in the amount of liver enzymes – shown up in the results of blood tests
  • Changes in appetite or behaviour concerning appetite
  • Muscle pain
  • Muscle spasms
  • Limp or weak muscles

Rare side effects (may affect less than 1 in 1,000 people)

  • Itchy, lumpy rash (urticaria)
  • Thinking things that are not true (delusions)
  • Changes in sex drive (libido)
  • You have discolouration of the skin or eyes, pain in the abdomen (stomach) or a bloated feeling, severe itching, pale or bloody stools, extreme weakness, nausea or loss of appetite. This could be caused by an infection or injury to the liver
  • An illness where removal of bile from the liver is blocked (cholestasis). Signs include jaundice, rash or fever and the colour of your water (urine) becomes darker
  • Changes in the way you walk

Very rare side effects (may affect less than 1 in 10,000 people)

  • Any changes of vision, in particular loss of vision
  • Slower breathing (respiratory depression)
  • Becoming dependent on Zolpidem Tartrate (Zolpitaj)

Not known (frequency cannot be estimated from available data)

  • A feeling of being out of touch with reality and being unable to think or judge clearly (psychosis)
  • Feeling angry or showing unusual behaviour
  • Needing to take more Zolpidem Tartrate (Zolpitaj) in order to sleep

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Zolpidem Tartrate (Zolpitaj)

Keep this medicine out of the sight and reach of children.

Do not use Zolpidem Tartrate (Zolpitaj) after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Zolpidem Tartrate (Zolpitaj) 10mg film-coated Tablets contain

  • Each tablet of Zolpidem Tartrate (Zolpitaj) contains 10mg of the active substance zolpidem tartrate.
  • Other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, titanium dioxide (E171), sodium starch glycollate, magnesium stearate and macrogol 400.

What Zolpidem Tartrate (Zolpitaj) 10mg film-coated Tablets look like and contents of the pack

Zolpidem Tartrate (Zolpitaj) is a white to off-white, film-coated, oblong (rectangle) shaped tablet with a scored and engraved ‘SN 10’ on one side contained within clear PVC/ foil blisters in cartons containing 4 or 28 tablets.

Not all pack sizes may be marketed.

  1. Marketed By:
    Taj Pharmaceuticals Ltd.
    15-6-108 Afjal Gunj.
    Hyderabad TS 500012, India.

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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.