Zolpidem Tartrate Tablets IP 5mg Technical Specification:

Product Name:Zolpidem Tartrate Tablets IP
Brand Name:(ZOLPITAJ)
Strength:(5mg), (10mg)
Dosage Form:Tablets(Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Sedative-hypnotics
Indication: Zolpidem 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.
Storage:Store below 30°C. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Zolpidem Tartrate Tablets IP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Zolpidem Tartrate Tablets IP 5mg
    Each Film-coated tablet contains:
    Zolpidem Tartrate IP……….……5mg
    Excipients……………………………..q.s
    Colour: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Zolpidem 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.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

SCHEDULE: SCHEDULE H1 CAUTION: TO BE SOLD BY RETAIL on THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.

Dosage: As directed by the Physician.

Why Taj pharmaceuticals?

At Taj Pharmaceuticals, we understand the critical importance of sleep in maintaining overall health and well-being. Our commitment to providing high-quality medications extends to Zolpidem Tartrate Tablets, which are widely used to address insomnia and sleep disorders. Here’s why you can trust Taj Pharmaceuticals for your sleep medication needs:

  • Pharmaceutical Excellence: Taj Pharmaceuticals has a longstanding reputation for pharmaceutical excellence. Our products are developed using state-of-the-art technology and adhere to strict quality control standards to ensure their safety and efficacy. We prioritize the health and satisfaction of our customers.
  • Reliable Treatment for Insomnia: Insomnia and sleep disturbances can significantly impact one’s quality of life. Zolpidem Tartrate is a trusted medication that helps individuals with insomnia fall asleep faster and stay asleep longer, promoting a more restful night’s sleep.
  • Expertise in Sleep Medicine: Taj Pharmaceuticals has a deep understanding of sleep medicine and the challenges faced by individuals struggling with sleep disorders. We collaborate with healthcare professionals and researchers to continually improve our products and provide effective solutions for sleep-related issues.
  • Patient-Centric Care: We prioritize patient-centric care, ensuring that individuals using Zolpidem Tartrate Tablets receive the support and information they need for safe and effective treatment. We are committed to helping people achieve better sleep and an improved quality of life.
  • Commitment to Well-Being:

Sleep is a vital component of a healthy lifestyle. Poor sleep can have far-reaching effects on physical and mental health. Taj Pharmaceuticals recognizes the importance of addressing sleep-related concerns and offers a reliable solution in the form of Zolpidem Tartrate Tablets. By choosing Taj Pharmaceuticals, you are choosing a trusted partner in your journey to better sleep. We are dedicated to providing you with high-quality medications that can make a positive difference in your life. Your health, comfort, and well-being are our top priorities, and we are committed to delivering excellence in pharmaceuticals, including Zolpidem Tartrate Tablets.

What is Zolpidem Tartrate Tablets and its uses:

Zolpidem tartrate is a medication commonly prescribed for the short-term treatment of insomnia, which is a condition characterized by difficulty falling asleep or staying asleep. It belongs to a class of drugs called sedative-hypnotics, which act on the central nervous system to help induce sleep.

Here are some key points about Zolpidem Tartrate Tablets:

  • Indications/Uses: Zolpidem tartrate is primarily used for the short-term treatment of insomnia in adults who have difficulty falling asleep or staying asleep. It is generally recommended for use when non-pharmacological approaches to managing insomnia, such as lifestyle and behavioral modifications, have not been effective.
  • Mechanism of Action: Zolpidem tartrate works by enhancing the effects of a neurotransmitter called gamma-aminobutyric acid (GABA) in the brain. GABA is responsible for reducing brain activity, which helps induce sleep and promote relaxation.
  • Dosage: The dosage of Zolpidem Tartrate Tablets can vary depending on the individual’s age, medical condition, and response to treatment. It is typically taken just before bedtime, and the recommended initial dose is usually low to minimize the risk of side effects.
  • Duration of Use: Zolpidem is intended for short-term use only, generally for a period of a few weeks. Prolonged use can lead to tolerance (requiring higher doses for the same effect) and dependence.
  • Side Effects: Common side effects of Zolpidem tartrate may include drowsiness, dizziness, headache, and a bitter or metallic taste in the mouth. More serious side effects, although less common, can include allergic reactions, abnormal behaviors while sleeping (e.g., sleepwalking), and memory problems.
  • Precautions: Zolpidem tartrate should be used cautiously and under medical supervision, especially in individuals with a history of substance abuse, depression, or other mental health disorders. It is generally not recommended for use in children or elderly individuals unless prescribed by a healthcare professional.
  • Dependence and Withdrawal: Prolonged or excessive use of Zolpidem can lead to dependence, meaning that the individual may develop a reliance on the medication to sleep. Abruptly stopping the medication after prolonged use can lead to withdrawal symptoms, including rebound insomnia.
  • Drug Interactions: Zolpidem tartrate can interact with other medications, including other central nervous system depressants like alcohol, which can increase the risk of side effects and impairment.

It’s important to note that Zolpidem tartrate should only be used under the guidance and supervision of a healthcare provider. They will determine the appropriate dosage and duration of treatment based on an individual’s specific needs and medical history. If you are experiencing insomnia or sleep disturbances, it is advisable to consult a healthcare professional to discuss the best treatment options for your condition.

How do Zolpidem Tartrate Tablets work?

Zolpidem tartrate tablets work by affecting certain neurotransmitters in the brain, primarily gamma-aminobutyric acid (GABA). GABA is a neurotransmitter that plays a key role in regulating brain activity. It has an inhibitory effect on the central nervous system, which means it reduces neuronal excitability and helps promote relaxation and sleep.

Here’s how Zolpidem Tartrate Tablets work:

  • Enhancing GABA Activity: Zolpidem is classified as a non-benzodiazepine sedative-hypnotic. It acts selectively on a subtype of GABA receptors known as the GABA-A receptors. These receptors are distributed throughout the brain and spinal cord and are responsible for inhibiting neuronal activity when GABA binds to them.
  • Reducing Brain Activity: When Zolpidem is ingested, it enhances the activity of GABA at the GABA-A receptors. This, in turn, increases the inhibitory effect of GABA on the brain. As a result, the overall activity of the central nervous system is reduced. Neuronal firing is slowed down, and this leads to a calming and sedative effect on the brain.
  • Inducing Sleep: By decreasing brain activity and promoting relaxation, Zolpidem helps individuals with insomnia fall asleep more easily. It is particularly effective at reducing the time it takes to fall asleep (sleep latency) and increasing the total duration of sleep.
  • Short Duration of Action: One of the advantages of Zolpidem is its relatively short duration of action. This means it primarily affects the initial stages of sleep and does not accumulate in the body when taken regularly. This characteristic makes it suitable for short-term treatment of insomnia.
  • Limited Impact on Deep Sleep: Unlike some other medications used for sleep, Zolpidem has less impact on the deeper stages of sleep, such as rapid eye movement (REM) sleep and slow-wave sleep. This means it may be less likely to disrupt the natural sleep cycle.

It’s important to note that Zolpidem tartrate should be used as directed by a healthcare professional and for short-term treatment of insomnia only. Prolonged or excessive use of the medication can lead to tolerance (requiring higher doses for the same effect) and dependence, and it may not be an appropriate long-term solution for sleep problems. Additionally, abrupt discontinuation after long-term use can lead to withdrawal symptoms and rebound insomnia. Therefore, it should be used under medical supervision and as part of a comprehensive approach to managing sleep disturbances.

Benefits and Side Effects of Zolpidem Tartrate Tablets:

Zolpidem tartrate tablets are primarily prescribed for the treatment of insomnia, and like many medications, they come with both benefits and potential side effects. It’s important to use this medication under the guidance and supervision of a healthcare professional who can assess the risks and benefits for your specific situation. Here’s an overview of the benefits and common side effects of Zolpidem Tartrate Tablets:

Benefits:

  • Effective for Insomnia: Zolpidem is known for its effectiveness in treating insomnia by helping individuals fall asleep faster and stay asleep longer. It can be particularly helpful for those who have difficulty initiating or maintaining sleep.
  • Quick Onset of Action: Zolpidem has a rapid onset of action, typically within 15-30 minutes after taking it, which can be advantageous for people who need to fall asleep quickly.
  • Short Duration of Action: It has a relatively short half-life, which means it doesn’t stay in the body for an extended period. This can reduce the likelihood of daytime drowsiness and grogginess compared to some other sleep medications.

Common Side Effects:

  • Drowsiness: Drowsiness is a common side effect of Zolpidem. While this is desired at bedtime, it can be problematic if taken during the day when alertness is required.
  • Dizziness: Some individuals may experience dizziness, especially when getting up from a sitting or lying position. Caution is needed when using Zolpidem, particularly at night.
  • Headache: Headaches are a relatively common side effect of Zolpidem.
  • Unpleasant Taste: Zolpidem tablets can leave a bitter or metallic taste in the mouth.

It’s important to use Zolpidem according to your healthcare provider’s instructions, taking the prescribed dosage and adhering to the recommended treatment duration. Zolpidem is generally intended for short-term use to minimize the risk of tolerance and dependence. If you experience any concerning side effects or have questions about your treatment, consult your healthcare provider promptly. Additionally, explore non-pharmacological approaches to managing insomnia, as medications should be just one part of a comprehensive approach to improving sleep.

Frequently Asked Questions About Zolpidem Tartrate Tablets:

Certainly, here are some frequently asked questions (FAQs) about Zolpidem Tartrate Tablets:

  1. What is Zolpidem Tartrate?

Zolpidem tartrate is a medication prescribed to treat insomnia, a condition characterized by difficulty falling asleep or staying asleep.

  1. How does Zolpidem work?

Zolpidem works by enhancing the activity of the neurotransmitter gamma aminobutyric acid (GABA) in the brain. This leads to reduced brain activity, promoting relaxation and sleep.

  1. What are the common brand names for Zolpidem Tartrate?

Zolpidem is available under various brand names, including Ambien, Ambien CR (controlled release), Edluar, and Intermezzo.

  1. Who should take Zolpidem Tartrate?

Zolpidem is typically prescribed to adults who have difficulty falling asleep or staying asleep due to insomnia. It should be used when nonpharmacological approaches to managing insomnia have been ineffective.

  1. Is Zolpidem habit-forming?

Yes, Zolpidem has the potential for dependence, meaning some individuals may become reliant on it to sleep. It is generally recommended for short-term use to minimize the risk of tolerance and dependence.

  1. How should I take Zolpidem Tartrate Tablets?

Zolpidem should be taken exactly as prescribed by your healthcare provider. Typically, it is taken just before bedtime and should not be crushed or chewed. Follow the dosing instructions on the prescription label.

  1. What are the common side effects of Zolpidem?

Common side effects may include drowsiness, dizziness, headache, and a bitter or metallic taste in the mouth. Some individuals may experience memory problems or unusual sleep behaviors.

  1. Can I drink alcohol while taking Zolpidem?

Alcohol should be avoided while taking Zolpidem, as it can increase the risk of side effects, including severe drowsiness and impaired coordination.

  1. Can Zolpidem be taken by pregnant or breastfeeding women?

Zolpidem should be used with caution during pregnancy and breastfeeding, and only if the potential benefits outweigh the risks. Consult with a healthcare provider for guidance.

  1. Is Zolpidem suitable for elderly individuals?

Zolpidem is generally not recommended for elderly individuals unless prescribed by a healthcare professional. It can increase the risk of falls and confusion in older adults.

  1. Can I stop taking Zolpidem suddenly?

It’s important not to abruptly stop taking Zolpidem, especially if you have been using it for an extended period. Stopping suddenly can lead to withdrawal symptoms and rebound insomnia. Consult with your healthcare provider to safely discontinue the medication.

  1. Are there any drug interactions with Zolpidem?

Zolpidem can interact with other medications, especially those that depress the central nervous system, such as other sedatives, tranquilizers, and alcohol. Inform your healthcare provider about all medications you are taking.

  1. Is Zolpidem available over the counter (OTC)?

In most countries, Zolpidem is available by prescription only and is not sold over the counter.

  1. Is Zolpidem safe for long-term use?

Zolpidem is generally recommended for short-term use, usually a few weeks, to avoid the development of tolerance and dependence. Long-term use should only be considered under close medical supervision.

Always consult with your healthcare provider or pharmacist if you have specific questions or concerns about Zolpidem Tartrate Tablets, and be sure to follow their recommendations for safe and effective use.

As Zolpidem Tartrate Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Zolpidem Tartrate Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Zolpidem Tartrate Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Zolpidem Tartrate Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Zolpidem Tartrate Tablets IP 5mg
2. Zolpidem Tartrate Tablets IP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Zolpidem Tartrate Tablets IP 5mg
Each Film-coated tablet contains:
Zolpidem Tartrate IP……….……5mg
Excipients……………………………..q.s
Colour: Sunset yellow FCF


2. Zolpidem Tartrate Tablets IP 10mg
Each Film-coated tablet contains:
Zolpidem Tartrate IP……….……10mg
Excipients…………………….………..q.s
Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Zolpidem 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.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H1 CAUTION: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.