What is Zolidan?
Zolidan is used to produce sleepiness or drowsiness and to relieve anxiety before surgery or certain procedures. Zolidan is also given to produce amnesia (loss of memory) so that the patient will not remember any discomfort or undesirable effects that may occur after a surgery or procedure. It is also used to produce loss of consciousness before and during surgery. Zolidan is sometimes used in patients in hospital intensive care units to cause unconsciousness. This may allow the patient to withstand the stress of being in the intensive care unit and help the patient cooperate when a machine must be used to assist with breathing.
Zolidan is given only by or under the immediate supervision of a doctor trained to use Zolidan. If you will be receiving Zolidan during surgery, your doctor or anesthesiologist will give you the medicine and closely follow your progress.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, Zolidan is used in certain patients with the following medical condition:
- Epilepsy
Zolidan indications
Zolidan Injection (Zolidan) is indicated -
- intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
- intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;
- intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time.
Intravenous Zolidan can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
- continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
Zolidan is associated with a high incidence of partial or complete impairment of recall for the next several hours.
How should I use Zolidan?
Use Zolidan syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zolidan syrup is intended for a single use only. You should not use Zolidan syrup for long-term use.
- Zolidan syrup is usually administered at your doctor's office, hospital, or clinic. If you are using Zolidan syrup at home, carefully follow the directions provided by your doctor or other health care provider.
- Avoid eating grapefruit or drinking grapefruit juice while you are taking Zolidan syrup.
- If you miss a dose of Zolidan syrup, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Zolidan syrup.
Uses of Zolidan in details
Use: Labeled Indications
Anesthesia: IV: Induction of general anesthesia before administration of other anesthetic agents; maintenance of anesthesia as a component of balanced anesthesia.
Sedation/anxiolysis/amnesia (preoperative/procedural):
IM: Preoperative sedation, anxiolysis, and amnesia.
IV: Sedation, anxiolysis, and amnesia prior to or during diagnostic, therapeutic, or endoscopic procedures, or prior to surgery.
Oral: Sedation, anxiolysis, and amnesia in children prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia.
Sedation for mechanically-ventilated patients: IV: Sedation of intubated and mechanically-ventilated patients as a component of anesthesia or during treatment in a critical care setting by continuous IV infusion.
Seizures, acute intermittent: Intranasal: Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy ≥12 years of age.
Off Label Uses
Status epilepticus
Data from a double-blind, randomized, noninferiority trial comparing the use of intramuscular Zolidan to intravenous lorazepam supports the use of intramuscular Zolidan for the treatment of status epilepticus.
Zolidan description
Zolidan also contains Midazolam 1 mg, benzyl alcohol 1% v/v as preservative and water for injection.
Zolidan is a short-acting, water soluble benzodiazepine used as a sedative and anesthetic agent. Because of its water solubility, it is well tolerated locally at the sites of IV or IM injection. Another notable feature of Zolidan is the good cardiovascular stability associated with its use. Zolidan is an imidazobendiazepine. It is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo(1,5-a)(1,4) benzodiazepine. The empirical formula of Zolidan is C18H13CIFN3 and its molecular weight is 325.8.
Zolidan dosage
Instructions Prior to Dosing
Zolidan prescribers should consider the following prior to initiation of treatment:
For patients at increased risk of respiratory depression from benzodiazepines, administration of Zolidan under healthcare professional supervision should be considered prior to treatment with Zolidan; this administration may be performed in the absence of a seizure episode.
Prior to treatment, the healthcare professional should instruct the individual administering Zolidan on how to identify seizure clusters and use the product appropriately. Patients and caregivers should be counseled to read carefully the "Instructions for Use" for complete directions on how to properly administer Zolidan.
Dosage Information
Administer Zolidan by the nasal route only.
Initial Dose: Administer one spray (5 mg dose) into one nostril.
Second Dose (if needed): One additional spray (5 mg dose) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose.
A second dose of Zolidan should not be administered if the patient has trouble breathing or if there is excessive sedation that is uncharacteristic of the patient during a seizure cluster episode.
Maximum Dosage and Treatment Frequency: Do not use more than 2 doses of Zolidan to treat a single episode.
It is recommended that Zolidan be used to treat no more than one episode every three days and no more than 5 episodes per month.
Zolidan interactions
See also:
What other drugs will affect Zolidan?
Enhancement of the central depressive effect may occur when Zolidan is used concomitantly with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptic drugs, anesthetics and sedative antihistamines.
There is a potentially relevant interaction between Zolidan and compounds which inhibit certain hepatic enzymes (particularly cytochrome P-450 IIIA). Data clearly indicate that these compounds influence the pharmacokinetics of Zolidan and that this may lead to prolonged sedation. At present, this reaction is known to occur in vivo with ketoconazole, itraconazole, erythromycin, diltiazem, verapamil, cimetidine and ranitidine (tablet), but not with cyclosporin (ampoule) and nitrendipine (ampoule).
Therefore, patients receiving the previously mentioned compounds or others which inhibit P-450 IIIA together with Zolidan IV should be monitored carefully for the first few hours after administration of Zolidan. (Studies have shown that ranitidine has no significant effect on the pharmacokinetics of IV given Zolidan.) In tablets, prescription of Zolidan should be avoided whenever possible. Otherwise, the dose of Zolidan tablet should be reduced.
Tablet: Not Recommended: Concomitant intake with alcohol.
The sedative effect may be enhanced when Zolidan is used in combination with alcohol. This affects the ability to drive or use machines.
Take into Account: Combination with CNS depressants.
In the case of narcotic analgesics, enhancement of the euphoria may also occur leading to an increase in psychological dependence.
Compounds which inhibit certain hepatic enzymes (particularly cytochrome P-450) may enhance the activity of benzodiazepines and benzodiazepine-like agents.
With regard to concomitant intake of Zolidan and erythromycin, the dose of Zolidan should be reduced by 50-75%. In such cases, the patient should be kept under careful surveillance.
Ampoule: One in vitro study has shown the hydroxylation of Zolidan to be inhibited by a number of other substances (eg, amiodarone, neuroleptics); accordingly, interaction with a whole range of medicaments is theoretically possible. However, there is no evidence that these results are of clinical relevance.
Alcohol may enhance the sedative effect of Zolidan.
Incompatibilities: Do not dilute Zolidan solutions with Macrodex 6% in dextrose.
Do not mix Zolidan solutions in alkaline injections. Zolidan precipitates in sodium bicarbonate.
Zolidan side effects
See also:
What are the possible side effects of Zolidan?
The following serious adverse reactions are discussed in more detail in other sections of the labeling:
- Risks from Concomitant Use with Opioids
- Risks of Cardiorespiratory Adverse Reactions
- CNS Depression from Concomitant Use with Other CNS Depressants or Moderate or Strong CYP3A4 Inhibitors
- Suicidal Behavior and Ideation
- Impaired Cognitive Function
- Glaucoma
- Other Adverse Reactions
Clinical Trials Experience
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 clinical practice.
Zolidan was studied for the outpatient treatment of a single seizure cluster in 292 adult and adolescent patients with epilepsy (Study 1). The study was conducted in two phases; an open-label Test Dose Phase followed by a double-blind, placebo-controlled, Comparative Phase. The mean age of patients enrolled in the Comparative Phase (N=201) was 33 years, 51% were female, and 95% were White.
Table 2 lists the adverse reactions occurring in 2% or more of the Zolidan-treated patients and at a rate greater than the placebo-treated patients in the Comparative Phase of Study 1.
| Body System/Adverse Reaction | Placebo | Zolidan† | |||
|---|---|---|---|---|---|
| Zolidan 5 mg | Placebo + Zolidan 5 mg | Zolidan 5 mg + 5 mg | Any Zolidan Treatment Group | ||
| N = 26 % | N = 91 % | N = 41 % | N = 43 % | N = 175 % | |
| |||||
| Nervous System | |||||
| Somnolence | 4 | 10 | 10 | 9 | 10 |
| Headache | 0 | 7 | 0 | 2 | 4 |
| Dysarthria | 0 | 2 | 2 | 2 | 2 |
| Application Site | |||||
| Nasal Discomfort | 8 | 5 | 7 | 16 | 9 |
| Throat Irritation | 0 | 2 | 2 | 7 | 3 |
| Rhinorrhea | 0 | 3 | 0 | 5 | 3 |
| Product Taste Abnormal | 0 | 4 | 0 | 0 | 2 |
| Eye Disorders | |||||
| Lacrimation Increased | 0 | 1 | 2 | 2 | 2 |
For patients who experienced a decrease in peripheral oxygen saturation in the Test Dose Phase of Study 1, the decreases were generally transitory. Two patients (one with a history of sleep apnea and one with intercurrent seizure) with decreases in peripheral oxygen saturation in the Test Dose Phase required therapeutic supplemental oxygen.
Zolidan contraindications
See also:
What is the most important information I should know about Zolidan?
Injection, oral: Hypersensitivity to Zolidan or any component of the formulation; intrathecal or epidural injection of parenteral forms containing preservatives (ie, benzyl alcohol); use in premature infants for parenteral forms containing benzyl alcohol; acute narrow-angle glaucoma.
Concurrent use of oral Zolidan with protease inhibitors (atazanavir, atazanavir-cobicistat, darunavir, indinavir, lopinavir-ritonavir, nelfinavir, ritonavir, saquinavir, tipranavir); concurrent use of oral or injectable Zolidan with fosamprenavir.
Intranasal: Hypersensitivity to Zolidan or any component of the formulation; acute narrow-angle glaucoma.
Documentation of allergenic cross-reactivity for benzodiazepines is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to benzodiazepines; acute pulmonary insufficiency; severe chronic obstructive pulmonary disease.
Active ingredient matches for Zolidan:
List of Zolidan substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| SEDOZ (Colombia) | |
| Sedoz 1mg x 1mL VIAL / 5ml (Claris Lifesciences) | $ 0.37 |
| Sedozolam (Turkey) | |
| Seizalam | |
| Setam (Mexico) | |
| Injectable; Injection; Midazolam Hydrochloride 5 mg / ml (Rimsa) | |
| Setam 400 mg x 10 Blister x 10 Tablet (Rimsa) | |
| SHORTAL (India) | |
| SHORTAL Injection / 5mg per ml / 1ml units (Themis Medicare Ltd.) | $ 0.24 |
| SHORTAL Injection / 1mg per ml / 5 x 5ml units (Themis Medicare Ltd.) | $ 1.81 |
| SHORTAL Injection / 1mg per ml / 5 x 10ml units (Themis Medicare Ltd.) | $ 3.13 |
| 1 mg x 1 mL x 10mlx5 (Themis Medicare Ltd.) | $ 3.13 |
| 1 mg x 1 mL x 5mlx5 (Themis Medicare Ltd.) | $ 1.81 |
| 5 mg x 1 mL x 1ML (Themis Medicare Ltd.) | $ 0.24 |
| Shortal 1mg x 1mL INJ / 10mlx5 (Themis Medicare Ltd.) | $ 3.13 |
| Shortal 1mg x 1mL INJ / 5mlx5 (Themis Medicare Ltd.) | $ 1.81 |
| Shortal 5mg x 1mL INJ / 1Ml (Themis Medicare Ltd.) | $ 0.24 |
| Shortal 10 mg Injection (Themis Medicare Ltd.) | $ 0.06 |
| Shortal 5 mg Injection (Themis Medicare Ltd.) | $ 0.07 |
| Shortal 5 mg 1 ml Injection (Themis Medicare Ltd.) | $ 0.24 |
| SHORTAL inj 1 mg x 1 mL x 10ml (Themis Medicare Ltd.) | $ 0.63 |
| SHORTAL inj 1 mg x 1 mL x 5ml (Themis Medicare Ltd.) | $ 0.36 |
| SHORTAL inj 5 mg x 1 mL x 1ml (Themis Medicare Ltd.) | $ 0.24 |
| Shortal 1mg x 1mL INJ / 10mlx5 (Themis Medicare Ltd.) | $ 3.13 |
| Shortal 1mg x 1mL INJ / 5mlx5 (Themis Medicare Ltd.) | $ 1.81 |
| Shortal 5mg x 1mL INJ / 1Ml (Themis Medicare Ltd.) | $ 0.24 |
| Sopodorm (Poland) | |
| Tab Mezolam | |
| Tab Mezolam 7.5 mg Tablet (Neon Laboratories Ltd) | $ 0.42 |
| Talentum (Italy, Peru) | |
| Terap (Chile) | |
| Tablet, Film-Coated; Oral; Midazolam Maleate 15 mg (Sanitas) | |
| Ukel | |
| Uzolam (Taiwan) | |
| Uzolam 5 mg/1 mL x 1 mL | |
| Uzolam 5 mg/1 mL x 3 mL | |
| Uzolam 5 mg/1 mL x 10 mL | |
| Versed | |
| Injectable; Injection; Midazolam Hydrochloride 1 mg / ml (Roche) | |
| Injectable; Injection; Midazolam Hydrochloride 5 mg / ml (Roche) | |
| Syrup; Oral; Midazolam Hydrochloride 2 mg / ml (Roche) | |
| Lotion; Topical; Selenium Sulfide 2.5% (Roche) | |
| Versed Injection | |
| Zolamid (Portugal) | |
| Zolidam (Brazil) | |
| Zolmid (Chile) | |
| Injectable; Injection; Midazolam 5 mg / ml | |
| ZOSLEEP | |
| ZOSLEEP INJECTION 1 vial / 10 ML injection each (Cachet Pharmaceuticals Pvt Ltd) | $ 0.83 |
| ZOSLEEP INJECTION 1 vial / 5 ML injection each (Cachet Pharmaceuticals Pvt Ltd) | $ 0.51 |
See 633 substitutes for Zolidan | |
References
- PubChem. "midazolam". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "midazolam". http://www.drugbank.ca/drugs/DB00683 (accessed September 17, 2018).
- MeSH. "Hypnotics and Sedatives". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Zolidan are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Zolidan. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yet2 consumers reported age
| Users | % | ||
|---|---|---|---|
| 46-60 | 1 | 50.0% | |
| > 60 | 1 | 50.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
