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Belbien (Zolpidem) 10 mg


Price/Pill: $3.65
Generic Name: Zolpidem
Manufacturer: Hemofarm

Zolpidem is used to treat insomnia (difficulty falling asleep or staying asleep). Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.

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How does Belbien,  Zolpidem work?

Belbien tablets contain the active ingredient Zolpidem, which is a type of medicine called a non-benzodiazepine hypnotic. It acts in the brain to aid sleep.

Zolpidem works by acting on receptors in the brain called GABA receptors, specifically the GABA-A receptors. This causes the release of a neurotransmitter called GABA in the brain.

GABA is a neurotransmitter that acts as a natural ‘nerve-calming’ agent. It helps keep the nerve activity in the brain in balance, and is involved in inducing sleepiness, reducing anxiety and relaxing muscles.

Zolpidem can be used as a short-term treatment for insomnia. This includes difficulty falling asleep, waking in the night, waking early in the morning and sleeping problems that are causing severe distress.

Zolpidem decreases the time taken to fall asleep and night-time awakenings, as well as increasing the total amount of time spent sleeping. However, it is only suitable for short-term treatment of insomnia (up to four weeks), as when used for longer periods it has a potential for dependence and addiction.

The medicine should be taken just before going to bed at night, or in bed.

What is Zolpidem used for?

• Short-term treatment of insomnia.

What is Belbien?

Belbien is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Belbien is used to treat insomnia. The immediate-release forms of Belbien are Belbien, Belbien,Edluar, and Belbien, which are used to help you fall asleep. The extended-release form of Belbien is Belbien, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Belbien, Edluar, and Belbien are used to help you fall asleep when you first go to bed. Belbien, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.

Your doctor will determine which form of Belbien is best for you.

Belbien may also be used for purposes not listed in this medication guide.

Belbien indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Belbien (Belbien tartrate)Oral Spray (Belbien tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Belbien tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

How should I use Belbien?

Use Belbien spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Belbien spray comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Belbien spray refilled.
  • Take Belbien spray by mouth on an empty stomach at least 2 hours after a meal.
  • Belbien spray works very quickly; use Belbien spray right before going to sleep.
  • Use Belbien spray only when you are able to get a full night’s sleep (7 to 8 hours).
  • Belbien spray needs to be primed before you use it for the first time. To prime Belbien spray, remove the child-resistant cap and inner clear protective cap. Point the spray opening away from your face and other people. Fully press down on the pump with your finger. Release and let the pump return to starting position. Repeat these steps 4 more times. You should see a fine spray. The medicine is now ready to use.
  • If Belbien spray has not been used within the last 14 days, reprime before using by pressing down 1 time on the pump.
  • To use Belbien spray, open your mouth and hold the container upright with the spray opening pointed directly into your mouth. Press all the way down on the pump and let the medicine spray directly into your mouth over your tongue. If your dose requires a second spray, repeat these steps. Keep the spray away from your eyes. Put the clear protective cap and child-resistant cap back on after each use.
  • Discard Belbien spray after 60 sprays have been used.
  • If you miss a dose of Belbien spray, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your total daily dose in any 24-hour period.

Ask your health care provider any questions you may have about how to use Belbien spray.

Uses of Belbien in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Belbien is used to treat sleep problems such as difficulty falling asleep, waking in the middle of the night, waking too early in adults that are causing distress and affecting every day life.

Belbien description

Belbien is a prescription short-acting nonbenzodiazepine hypnotic that potentiates gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by binding to benzodiazepine receptors which are located on the gamma-aminobutyric acid receptors. Belbien is used for the short-term treatment of insomnia. It works quickly (usually within 15 minutes) and has a short half-life (2-3 hours). It is classified as an imidazopyridine. As an anticonvulsant and muscle relaxant, the beneficial effects start to emerge at 10 and 20 times the dose required for sedation, respectively. For that reason, it has never been approved for either muscle relaxation or seizure prevention. Recently, Belbien has been cited in various medical reports mainly in the United Kingdom as waking persistent vegetative state (PVS) patients, and dramatically improving the conditions of people with brain injuries. [Wikipedia]

Belbien dosage

The dose of Belbien (Belbien tartrate oral spray) should be individualized. Dosage in adultsThe recommended dose for adults is 10 mg once daily immediately before bedtime. The total Belbien (Belbien tartrate oral spray) dose should not exceed 10 mg per day.

Special populationsElderly or debilitated patients may be especially sensitive to the effects of Belbien tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Belbien (Belbien tartrate oral spray) in both of these patient populations is 5 mg once daily immediately before bedtime.

Use with CNS depressantsDosage adjustment may be necessary when Belbien (Belbien tartrate oral spray) is combined with other CNS-depressant drugs because of the potentially additive effects.

AdministrationBelbien (Belbien tartrate oral spray) is packaged in a child-resistant container. For detailed instructions on how to use Belbien (Belbien tartrate oral spray), refer to the Patient Instructions for Use (following the Medication Guide). Belbien (Belbien tartrate oral spray) must be primed before it is used for the first time. To prime, patients should be told to point the black spray opening away from their face and other people and spray 5 times. For administration, the child-resistant container should be held upright with the black spray opening pointed directly into the mouth. The patient should fully press down on the pump to make sure a full dose (5 mg) of Belbien (Belbien tartrate oral spray) is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed, a second spray should be administered.

If the patient does not use Belbien (Belbien tartrate oral spray) for at least 14 days, it must be primed again with 1 spray. The patient should be referred to the Patient Instructions for Use included at the end of the Medication Guide.

The effect of Belbien (Belbien tartrate oral spray) may be slowed by ingestion with or immediately after a meal.

How supplied

Dosage Forms And StrengthsBelbien (Belbien tartrate oral spray) is available as a clear, colorless, and cherry flavored solution designed to be sprayed directly into the mouth over the tongue. Each metered actuation (one spray) of Belbien delivers 5 mg of Belbien tartrate in 100 μL. Two actuations deliver 10 mg of Belbien tartrate.

After an initial priming of 5 actuations, there are 60 metered actuations in each child-resistant container. The total number of available doses is dependent on the number of actuations per dose (1 or 2 actuations) and the frequency of priming.

Storage And HandlingBelbien (Belbien tartrate oral spray) is available in a child-resistant container. Each container includes a child-resistant cap and base with a metered-dose pump assembly and clear over cap. Each container contains 8.2 g of product formulation. One and two actuations of Belbien are equal to 5 and 10 mg of Belbien tartrate, respectively. There are 60 metered actuations per container after 5 initial priming actuations. Belbien (Belbien tartrate oral spray) is supplied as:

NDC Number Size XXXXX-001-01 Carton includes a child-resistant container with 8.2 g of product formulation; 60 metered actuations per containerStore upright at 25 °C (77 °F) with excursions permitted to 15-30 °C (59-86 °F) (USP Controlled Room Temperature). Do not freeze. Avoid prolonged product exposure to temperatures above 30 °C (86 °F). The child-resistant container should be discarded when the labeled number of actuations (60 sprays) have been used.

KEEP OUT OF REACH OF CHILDREN.

Revised December 2008. Manufactured for: NovaDel Pharma Inc., Flemington, NJ 08822. By : Rechon Life Sciences AB, SE-216 10 Limhamn, Sweden. FDA rev date: 12/19/2008

Belbien interactions

CNS-Active DrugsBelbien tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. A study involving haloperidol and Belbien revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of Belbien. Imipramine in combination with Belbien produced no pharmacokinetic interaction other a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with Belbien produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration.

An additive effect on psychomotor performance between alcohol and Belbien was demonstrated.

A single-dose interaction study with Belbien 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of Belbien and fluoxetine at steady-state concentrations were evaluated in healthy females, the only significant change was a 17% increase in the Belbien half-life. There was no evidence of an additive effect in psychomotor performance.

Following five consecutive nightly doses of Belbien 10 mg in the presence of sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), Belbien C max was significantly higher (43%) and T max was significantly decreased (53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by Belbien.

Since the systemic evaluation of Belbien tartrate in combination with other CNS-active drugs have been limited, careful consideration should be given to the pharmacology of any CNS-active drug to be used with Belbien. Any drug with CNS-depressant effects could potentially enhance the CNS- depressant effects of Belbien.

Drugs that affect drug metabolism via cytochrome P450: A randomized, double-blind, crossover interaction study in ten healthy volunteers between itraconazole (200 mg once daily for 4 days) and a single dose of Belbien (10 mg) given 5 hours after the last dose of itraconazole resulted in a 34% increase in AUC0-> of Belbien. There were no significant pharmacodynamic effects of Belbien on subjective drowsiness, postural sway, or psychomotor performance.

A randomized, placebo-controlled, crossover interaction study in eight healthy female volunteers between 5 consecutive daily doses of rifampin (600 mg) and a single dose of Belbien (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (ñ73%), Cmax (ñ58%), and T1/2 (ñ36%) of Belbien together with significant reductions in the pharmacodynamic effects of Belbien.

Other Drugs

A study involving cimetidine/Belbien and ranitidine/Belbien combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of Belbien. Belbien had no effect on digoxin kinetics and did not effect prothrombin time when given with warfarin in normal subjects. Ivadals sedative/hypnotic effect was reversed by flumazenil; however, no significant alterations in Belbien pharmacokinetics were found.

Belbien side effects

The following serious adverse reactions in Belbien-treated patients are discussed in greater detail in other sections of the labeling:

  • CNS-depressant effects and next-day impairment
  • Serious anaphylactic and anaphylactoid reactions
  • Abnormal thinking and behavioral changes, and complex behaviors
  • Withdrawal effects

Clinical Trials ExperienceThe safety data described below are based on two double-blind placebo-controlled trials of Belbien in adult patients with insomnia characterized by difficulty returning to sleep after a middle-of-the-night awakening. These two trials included 230 and 82 patients treated with 3.5 mg and 1.75 mg of Belbien, respectively. The first study was a 3way crossover sleep-laboratory study in 82 patients (58 female and 24 male; median age 47 years; 51% Caucasian, 44% African-American) of 1.75 mg and 3.5 mg of Belbien compared to placebo (Study 1). The second study was a 4-week, parallel-group at-home study in 295 patients (201 female and 94 male; median age 43 years) of 3.5 mg of Belbien compared to placebo, used on an as-needed basis after spontaneous middle-of-the-night awakenings (Study 2). In Study 2, patients took Belbien during the night on 62% of study nights.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in actual practice.

Table 1 shows the incidence of adverse reactions reported in Study 2 that occurred in 2% or more of Belbien-treated (3.5 mg) patients in which the incidence was greater than the incidence in placebo-treated patients. For women and other patients taking the 1.75 mg dose in Study 1, the incidence of adverse reactions was similar to the incidence seen with 3.5 mg of Belbien in Table 1.

The most commonly reported adverse reactions in all treatment groups were headache, nausea, and fatigue.

Table 1: Summary of Adverse Reactions ( 2%) in Outpatient, Double-Blind, Parallel-Group, Placebo-Controlled Study (Study 2)

MedDRA System Organ Class Preferred Term

3.5 mg Belbien(n=150)

Placebo(n=145)

Gastrointestinal Disorders 4% 2% Nausea 1% 1% General Disorders and Administration Site Conditions 3% 0% Fatigue 1% 0% Nervous System Disorders 5% 3% Headache 3% 1% Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of Belbien. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.

  • Application site reactions, primarily in the sublingual area, have been reported. These application site reactions included oral ulcers, blisters, and mucosal inflammation.

Belbien contraindications

In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for Belbien. If you have taken Belbien in the past, your doctor may direct you to take a lower dose of this medicine than you did before.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of Belbien are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Belbien may impair your thinking or reactions. You may still feel sleepy the morning after taking Belbien, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Belbien and talk with your doctor about another treatment for your sleep disorder.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Belbien may be habit forming. Keep the medication in a place where others cannot get to it.

Belbien may cause a severe allergic reaction. Stop taking Belbien and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Warning!
• This medicine causes drowsiness and impairs concentration and alertness. These effects may continue into the following day and are made worse by drinking alcohol. If you are affected you should avoid potentially hazardous tasks such as driving or operating machinery. Do not drink alcohol when taking this medicine.

• You should only take this medicine before going to bed at night. If you forget to take it at bedtime don’t take it at any other time, or you may end up feeling drowsy, dizzy and confused during the day.

Active ingredient matches for Belbien:

Zolpidem in Serbia.

List of Belbien substitutes (brand and generic names)Sort by popularity Unit description / dosage (Manufacturer)Price, USD Balidorm BENZOPAM BENZOPAM 2MG TABLET 1 strip / 10 tablets each (Achemic)$ 0.14 BENZOPAM 5MG TABLET 1 strip / 10 tablets each (Achemic)$ 0.24 Benzopam 5mg Tablet (Achemic)$ 0.02 Bikalm (Germany) Tablet, Film-Coated; Oral; Zolpidem Tartrate 10 mg (sanofi-aventis) Tablets, Film-Coated; Oral; Zolpidem Tartrate 10 mg (sanofi-aventis) Bunapte (Romania) Cedrol Cymerion (Portugal) DACTIVE (India) DACTIVE Capsule/ Tablet / 5mg / 10 units (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.32 DACTIVE Capsule/ Tablet / 10mg / 10 units (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.48 Dactive 5mg TAB / 10 (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.32 Dactive 10mg TAB / 10 (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.48 5 mg x 10’s (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.32 10 mg x 10’s (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.48 Dactive 5 mg Tablet (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.03 Dactive 10 mg Tablet (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.05 DACTIVE 10MG TABLET 1 strip / 10 tablets each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.48 DACTIVE 12.5MG TABLET 1 strip / 7 tablets each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.93 DACTIVE 12.5MG TABLET SR 1 strip / 10 tablet srs each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.94 DACTIVE 12.5MG TABLET SR 1 strip / 5 tablet srs each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 1.07 DACTIVE 12.5MG TABLET SR 1 strip / 7 tablet srs each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.97 DACTIVE 5MG TABLET 1 strip / 10 tablets each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.32 DACTIVE 6.25MG TABLET 1 strip / 7 tablets each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.77 DACTIVE SR 6.25MG TABLET 1 strip / 7 tablets each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 1.02 DACTIVE SR 6.5MG TABLET 1 strip / 10 tablets each (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.77 DACTIVE tab 5 mg x 10’s (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.32 DACTIVE tab 10 mg x 10’s (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.48 Dactive 5mg TAB / 10 (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.32 Dactive 10mg TAB / 10 (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.48 Dactive 10mg Tablet (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.05 Dactive 12.5mg Tablet (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.13 Dactive 5mg Tablet (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.03 Dactive 6.25mg Tablet (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.11 Dactive 6.25mg Tablet SR (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.15 Dactive 6.5mg Tablet SR (Zydus Neurosciences (Zydus Cadila Healthcare Ltd))$ 0.08 Dactive 10 (Taiwan) Dactive 10 10 mg Dalparan (Spain) Damixan (Chile) Tablet, Film-Coated; Oral; Zolpidem Tartrate 10 mg Tablets, Film-Coated; Oral; Zolpidem Tartrate 10 mg DEM (India) 5 mg x 10’s (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.59 10 mg x 10’s (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.97 See 996 substitutes for Belbien

References

  1. PubChem. “zolpidem”. https://pubchem.ncbi.nlm.nih.gov/com…
  2. DrugBank. “zolpidem”. http://www.drugbank.ca/drugs/DB00425
  3. MeSH. “GABA-A Receptor Agonists”. https://www.ncbi.nlm.nih.gov/mesh/68…

More about Belbien

Hemofarm Belbien Zolpidem

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