What are the possible side effects of Zolam?
Get emergency medical help if you have any of these signs of an allergic reaction to Zolam: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
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unusual risk-taking behavior, decreased inhibitions, no fear of danger;
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depressed mood, thoughts of suicide or hurting yourself;
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hyperactivity, agitation, hostility, hallucinations;
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feeling light-headed, fainting;
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seizure (convulsions);
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urinating less than usual or not at all;
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muscle twitching, tremor; or
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jaundice (yellowing of the skin or eyes).
Less serious Zolam side effects may include:
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drowsiness, dizziness, feeling irritable;
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amnesia or forgetfulness, trouble concentrating;
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sleep problems (insomnia);
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muscle weakness, lack of balance or coordination, slurred speech;
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blurred vision;
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nausea, vomiting, constipation, appetite or weight changes;
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dry or watery mouth, increased sweating; or
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loss of interest in sex.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Zolam in details
The information included in the subsection on Adverse Events Observed in Short-Term, Placebo-Controlled Trials with Zolam XR tablets is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder.
Adverse event reports were elicited either by general inquiry or by checklist, and were recorded by clinical investigators using terminology of their own choosing. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened during therapy following baseline evaluation. In the tables and tabulations that follow, standard MedDRA terminology (version 4.0) was used to classify reported adverse events.
Adverse Events Observed in Short-Term, Placebo-Controlled Trials of Zolam XR
Adverse Events Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled TrialsApproximately 17% of the 531 patients who received Zolam XR in placebo-controlled clinical trials for panic disorder had at least one adverse event that led to discontinuation compared to 8% of 349 placebo-treated patients. The most common events leading to discontinuation and considered to be drug-related (ie, leading to discontinuation in at least 1% of the patients treated with Zolam XR at a rate at least twice that of placebo) are shown in the following table.
| System Organ Class/Adverse Event | Percentage of Patients Discontinuing Due to Adverse Events | |
|---|---|---|
| Zolam XR (n=531) | Placebo (n=349) | |
| Nervous system disorders | ||
| Sedation | 7.5 | 0.6 |
| Somnolence | 3.2 | 0.3 |
| Dysarthria | 2.1 | 0 |
| Coordination abnormal | 1.9 | 0.3 |
| Memory impairment | 1.5 | 0.3 |
| General disorders/administration site conditions | ||
| Fatigue | 1.7 | 0.6 |
| Psychiatric disorders | ||
| Depression | 2.5 | 1.2 |
The prescriber should be aware that adverse event incidence cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with event incidence obtained from other clinical investigations involving different treatments, uses, and investigators. The cited values, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.
The following table shows the incidence of treatment-emergent adverse events that occurred during 6- to 8-week placebo-controlled trials in 1% or more of patients treated with Zolam XR where the incidence in patients treated with Zolam XR was greater than the incidence in placebo-treated patients. The most commonly observed adverse events in panic disorder patients treated with Zolam XR (incidence of 5% or greater and at least twice the incidence in placebo patients) were: sedation, somnolence, memory impairment, dysarthria, coordination abnormal, ataxia, libido decreased.
| System Organ Class/Adverse Event | Percentage of Patients Reporting Adverse Event | |
|---|---|---|
| Zolam XR (n=531) | Placebo (n=349) | |
| Nervous system disorders | ||
| Sedation | 45.2 | 22.6 |
| Somnolence | 23.0 | 6.0 |
| Memory impairment | 15.4 | 6.9 |
| Dysarthria | 10.9 | 2.6 |
| Coordination abnormal | 9.4 | 0.9 |
| Mental impairment | 7.2 | 5.7 |
| Ataxia | 7.2 | 3.2 |
| Disturbance in attention | 3.2 | 0.6 |
| Balance impaired | 3.2 | 0.6 |
| Paresthesia | 2.4 | 1.7 |
| Dyskinesia | 1.7 | 1.4 |
| Hypoesthesia | 1.3 | 0.3 |
| Hypersomnia | 1.3 | 0 |
| General disorders/administration site conditions | ||
| Fatigue | 13.9 | 9.2 |
| Lethargy | 1.7 | 0.6 |
| Infections and infestations | ||
| Influenza | 2.4 | 2.3 |
| Upper respiratory tract infections | 1.9 | 1.7 |
| Psychiatric disorders | ||
| Depression | 12.1 | 9.2 |
| Libido decreased | 6.0 | 2.3 |
| Disorientation | 1.5 | 0 |
| Confusion | 1.5 | 0.9 |
| Depressed mood | 1.3 | 0.3 |
| Anxiety | 1.1 | 0.6 |
| Metabolism and nutrition disorders | ||
| Appetite decreased | 7.3 | 7.2 |
| Appetite increased | 7.0 | 6.0 |
| Anorexia | 1.5 | 0 |
| Gastrointestinal disorders | ||
| Dry mouth | 10.2 | 9.7 |
| Constipation | 8.1 | 4.3 |
| Nausea | 6.0 | 3.2 |
| Pharyngolaryngeal pain | 3.2 | 2.6 |
| Investigations | ||
| Weight increased | 5.1 | 4.3 |
| Weight decreased | 4.3 | 3.7 |
| Injury, poisoning, and procedural complications | ||
| Road traffic accident | 1.5 | 0 |
| Reproductive system and breast disorders | ||
| Dysmenorrhea | 3.6 | 2.9 |
| Sexual dysfunction | 2.4 | 1.1 |
| Premenstrual syndrome | 1.7 | 0.6 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 2.4 | 0.6 |
| Myalgia | 1.5 | 1.1 |
| Pain in limb | 1.1 | 0.3 |
| Vascular disorders | ||
| Hot flushes | 1.5 | 1.4 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Dyspnea | 1.5 | 0.3 |
| Rhinitis allergic | 1.1 | 0.6 |
| Skin and subcutaneous tissue disorders | ||
| Pruritis | 1.1 | 0.9 |
Following is a list of MedDRA terms that reflect treatment-emergent adverse events reported by 531 patients with panic disorder treated with Zolam XR. All potentially important reported events are included except those already listed in the above table or elsewhere in labeling, those events for which a drug cause was remote, those event terms that were so general as to be uninformative, and those events that occurred at rates similar to background rates in the general population. It is important to emphasize that, although the events reported occurred during treatment with Zolam XR, they were not necessarily caused by the drug. Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on 1 or more occasions in at least l/l00 patients; infrequent adverse events are those occurring in less than l/100 patients but at least l/1000 patients; rare events are those occurring in fewer than l/1000 patients.
Cardiac disorders: Frequent: palpitation; Infrequent: sinus tachycardia
Ear and Labyrinth disorders: Frequent: Vertigo; Infrequent: tinnitus, ear pain
Eye disorders: Frequent: blurred vision; Infrequent: tmydriasis, photophobia
Gastrointestinal disorders: Frequent: diarrhea, vomiting, dyspepsia, abdominal pain; Infrequent: dysphagia, salivary hypersecretion
General disorders and administration site conditions: Frequent: malaise, weakness, chest pains; Infrequent: fall, pyrexia, thirst, feeling hot and cold, edema, feeling jittery, sluggishness, asthenia, feeling drunk, chest tightness, increased energy, feeling of relaxation, hangover, loss of control of legs, rigors
Musculoskeletal and connective tissue disorders: Frequent: back pain, muscle cramps, muscle twitching
Nervous system disorders: Frequent: headache, dizziness, tremor; Infrequent: amnesia, clumsiness, syncope, hypotonia, seizures, depressed level of consciousness, sleep apnea syndrome, sleep talking, stupor
Psychiatric system disorders: Frequent: irritability, insomnia, nervousness, derealization, libido increased, restlessness, agitation, depersonalization, nightmare; Infrequent: abnormal dreams, apathy, aggression, anger, bradyphrenia, euphoric mood, logorrhea, mood swings, dysphonia, hallucination, homicidal ideation, mania, hypomania, impulse control, psychomotor retardation, suicidal ideation
Renal and urinary disorders: Frequent: difficulty in micturition; Infrequent: urinary frequency, urinary incontinence
Respiratory, thoracic, and mediastinal disorders: Frequent: nasal congestion, hyperventilation; Infrequent: choking sensation, epistaxis, rhinorrhea
Skin and subcutaneous tissue disorders: Frequent: sweating increased; Infrequent: clamminess, rash, urticaria
Vascular disorders: Infrequent: hypotension
The categories of adverse events reported in the clinical development program for Zolam tablets in the treatment of panic disorder differ somewhat from those reported for Zolam XR tablets because the clinical trials with Zolam tablets and Zolam XR tablets used different standard medical nomenclature for reporting the adverse events. Nevertheless, the types of adverse events reported in the clinical trials with Zolam tablets were generally the same as those reported in the clinical trials with Zolam XR tablets.
Discontinuation-Emergent Adverse Events Occurring at an Incidence of 5% or More Among Patients Treated with Zolam XR
The following table shows the incidence of discontinuation-emergent adverse events that occurred during short-term, placebo-controlled trials in 5% or more of patients treated with Zolam XR where the incidence in patients treated with Zolam XR was two times greater than the incidence in placebo-treated patients.
| System Organ Class/Adverse Event | Percentage of Patients Reporting Adverse Event | |
|---|---|---|
| Zolam XR (n=422) | Placebo (n=261) | |
| Nervous system disorders | ||
| Tremor | 28.2 | 10.7 |
| Headache | 26.5 | 12.6 |
| Hypoesthesia | 7.8 | 2.3 |
| Paraesthesia | 7.1 | 2.7 |
| Psychiatric disorders | ||
| Insomnia | 24.2 | 9.6 |
| Nervousness | 21.8 | 8.8 |
| Depression | 10.9 | 5.0 |
| Derealization | 8.0 | 3.8 |
| Anxiety | 7.8 | 2.7 |
| Depersonalization | 5.7 | 1.9 |
| Gastrointestinal disorders | ||
| Diarrhea | 12.1 | 3.1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Hyperventilation | 8.5 | 2.7 |
| Metabolism and nutrition disorders | ||
| Appetite decreased | 9.5 | 3.8 |
| Musculosketal and connective tissue disorders | ||
| Muscle twitching | 7.4 | 2.7 |
| Vascular disorders | ||
| Hot flushes | 5.9 | 2.7 |
There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of Zolam.
To discontinue treatment in patients taking Zolam XR tablets, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of Zolam XR tablets be decreased by no more than 0.5 mg every three days. Some patients may benefit from an even slower dosage reduction. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.
As with all benzodiazepines, paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations, and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, Zolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of Zolam in patients with posttraumatic stress disorder.
Post Introduction Reports
Various adverse drug reactions have been reported in association with the use of Zolam tablets since market introduction. The majority of these reactions were reported through the medical event voluntary reporting system. Because of the spontaneous nature of the reporting of medical events and the lack of controls, a causal relationship to the use of Zolam tablets cannot be readily determined. Reported events include: gastrointestinal disorder, hypomania, mania, liver enzyme elevations, hepatitis, jaundice, hepatic failure, Stevens-Johnson syndrome, photosensitivity reaction, angioedema, peripheral edema, menstruation irregular, hyperprolactinemia, gynecomastia, and galactorrhea..
What is the most important information I should know about Zolam?
- Zolam solution may cause drowsiness, dizziness, light-headedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Zolam solution. Using Zolam solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
- Do not drink alcohol while you are using Zolam solution.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Zolam solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Smoking may decrease Zolam solution's effectiveness. Tell your doctor if you smoke or if you have recently stopped smoking.
- Tell your doctor or dentist that you take Zolam solution before you receive any medical or dental care, emergency care, or surgery.
- Use Zolam solution with caution in the ELDERLY; they may be more sensitive to its effects, especially decreased coordination and drowsiness.
- Zolam solution should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Zolam solution may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Zolam solution during pregnancy. Zolam solution is found in breast milk. Do not breast-feed while taking Zolam solution.
When used for long periods of time or at high doses, Zolam solution may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Zolam solution stops working well. Do not take more than prescribed.
Some people who use Zolam solution may develop a need to continue taking it. People who take higher doses (eg, some patients with panic disorder) or use Zolam solution for a long time have a greater risk. This is known as DEPENDENCE or addiction. If you stop taking Zolam solution suddenly, you may have WITHDRAWAL symptoms. These may include blurred vision; burning, numbness, or tingling; changes in smell or other senses; decreased appetite; decreased awareness of your surroundings; decreased concentration; diarrhea; muscle cramps or twitches; seizures; or weight loss.
Zolam contraindications
Do not use Zolam if you are pregnant. It could harm the unborn baby.
Do not use this medication if you are allergic to Zolam or to other benzodiazepines, such as chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).
Before you take Zolam, tell your doctor if you have asthma or other breathing problems, glaucoma, kidney or liver disease, a history of alcoholism, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.
Do not drink alcohol while taking Zolam. This medication can increase the effects of alcohol.
Zolam may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.
References
- DailyMed. "ALPRAZOLAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "alprazolam: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Alprazolam: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Zolam 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 Zolam. 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 side effects
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
