"The Cerêve Sleep System, a prescription device that helps reduce latency to stage 1 and stage 2 sleep by keeping the forehead cool has received US Food and Drug Administration (FDA) commercial clearance for use in patients with insomnia, the comp"...
Prosom Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
ProSom (estazolam) is a benzodiazepine used to treat insomnia symptoms, such as trouble falling or staying asleep. Common side effects of ProSom include:
- loss of balance or coordination,
- blurred vision,
- daytime drowsiness (or during hours when you are not normally sleeping),
- amnesia or forgetfulness,
- muscle weakness,
- pain, or
- tingly feeling,
- blurred vision,
- stomach discomfort,
- dry mouth, or
- increased thirst.
Tell your doctor if you have serious side effects of ProSom including:
- memory loss,
- mental/mood/behavior changes (such as new or worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, or anxiety).
The recommended initial dose of ProSom for adults is 1 mg at bedtime. ProSom may interact with cimetidine, diltiazem, antibiotics, antidepressants, barbiturates, MAO inhibitors, medicines to treat psychiatric disorders, or seizure medications. Tell your doctor all medications you use. ProSom must not be used during pregnancy. Other medications in this class have caused birth defects when used in the first three months of pregnancy. Other medications in this class have also caused unusual drowsiness, feeding problems, and liver problems in newborns when used at or near the time of delivery, or withdrawal symptoms in newborns when used during pregnancy. Women should use birth control while taking this drug. Based on information from related drugs, this drug may pass into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using this drug is not recommended. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our ProSom (estazolam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Prosom in Detail - Patient Information: Side Effects
Estazolam may cause a severe allergic reaction. Stop taking estazolam 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.
Stop using estazolam and call your doctor at once if you have any of these serious side effects:
- weak or shallow breathing;
- fast or pounding heartbeats;
- confusion, slurred speech, unusual thoughts or behavior;
- hallucinations, agitation, aggression;
- thoughts of suicide or hurting yourself;
- restless muscle movements in your eyes, tongue, jaw, or neck;
- pale skin, easy bruising or bleeding, unusual weakness;
- fever, chills, body aches, flu symptoms;
- problems with urination; or
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- daytime drowsiness (or during hours when you are not normally sleeping);
- amnesia or forgetfulness;
- muscle weakness, lack of balance or coordination;
- numbness, burning, pain, or tingly feeling;
- headache, blurred vision, depressed mood;
- feeling nervous, excited, or irritable;
- nausea, vomiting, stomach discomfort; or
- dry mouth, increased thirst.
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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Prosom (Estazolam)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Prosom Overview - Patient Information: Side Effects
This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).
Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking estazolam.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Prosom (Estazolam)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Prosom FDA Prescribing Information: Side Effects
Commonly Observed: The most commonly observed adverse events associated with the use of ProSom (estazolam) , not seen at an equivalent incidence among placebo-treated patients were somnolence, hypokinesia, dizziness, and abnormal coordination.
Associated with Discontinuation of Treatment: Approximately 3% of 1277 patients who received ProSom (estazolam) in US premarketing clinical trials discontinued treatment because of an adverse clinical event. The only event commonly associated with discontinuation, accounting for 1.3% of the total, was somnolence.
Incidence in Controlled Clinical Trials: The table below enumerates adverse events that occurred at an incidence of 1% or greater among patients with insomnia who received ProSom (estazolam) in 7-night, placebo-controlled trials. Events reported by investigators were classified into standard dictionary (COSTART) terms to establish event frequencies. Event frequencies reported were not corrected for the occurrence of these events at baseline. The frequencies were obtained from data pooled across six studies: ProSom (estazolam) , N=685; placebo, N=433. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice in which patient characteristics and other factors differ from those that prevailed in these six clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials was conducted under a different set of conditions. However, the cited figures provide the physician with a basis of estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.
INCIDENCE OF ADVERSE EXPERIENCES IN PLACEBO-CONTROLLED CLINICAL
TRIALS (Percentage of Patients Reporting)
|Body System/Adverse Event*||ProSom
|Body as a Whole|
|Lower extremity pain||3||2|
|Skin and Appendages|
|*Events reported by at least 1% of ProSom patients.|
Other Adverse Events
During clinical trials conducted by Abbott, some of which were not placebo-controlled, ProSom (estazolam) was administered to approximately 1300 patients. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing adverse events, similar types of untoward events must be grouped into a smaller number of standardized event categories. In the tabulations that follow, a standard COSTART dictionary terminology has been used to classify reported adverse events. Thefrequencies presented, therefore, represent the proportion of the 1277 individuals exposed to ProSom (estazolam) who experienced an event of the type cited on at least one occasion while receiving ProSom (estazolam) . All reported events are included except those already listed in the previous table, those COSTART terms too general to be informative, and those events where a drug cause was remote. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in less than 1/1000 patients. It is important to emphasize that, although the events reported did occur during treatment with ProSom (estazolam) , they were not necessarily caused by it.
Nervous System - Frequent: anxiety; Infrequent: agitation, amnesia, apathy, emotional lability, euphoria, hostility, paresthesia, seizure, sleep disorder, stupor, twitch; Rare: ataxia, circumoral paresthesia, decreased libido, decreased reflexes, hallucinations, neuritis, nystagmus, tremor.
Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during ProSom (estazolam) therapy or withdrawal and are of no known clinical significance.
Urogenital System - Infrequent: frequent urination, menstrual cramps, urinary hesitancy, urinary urgency, vaginal discharge/itching; Rare: hematuria, nocturia, oliguria, penile discharge, urinary incontinence.
Postintroduction Reports - Voluntary reports of non-US postmarketing experience with estazolam have included rare occurrences of photosensitivity, Stevens-Johnson syndrome, and agranulocytosis. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to estazolam treatment has not been determined.
Drug Abuse And Dependence
Controlled Substance: ProSom (estazolam) tablets are a controlled substance in Schedule IV.
Abuse and Dependence: Withdrawal symptoms similar to those noted with sedatives/hypnotics and alcohol have occurred following the abrupt discontinuation of drugs in the benzodiazepine class. The symptoms can range from mild dysphoria and insomnia to a major syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions.
Although withdrawal symptoms are more commonly noted after the discontinuation of higher than therapeutic doses of benzodiazepines, a proportion of patients taking benzodiazepines chronically at therapeutic doses may become physically dependent on them. Available data, however, cannot provide a reliable estimate of the incidence of dependency or the relationship of the dependency to dose and duration of treatment. There is some evidence to suggest that gradual reduction of dosage will attenuate or eliminate some withdrawal phenomena. In most instances, withdrawal phenomena are relatively mild and transient; however, life-threatening events (eg, seizures, delirium, etc.) have been reported.
Gradual withdrawal is the preferred course for any patient taking benzodiazepines for a prolonged period. Patients with a history of seizures, regardless of their concomitant antiseizure drug therapy, should not be withdrawn abruptly from benzodiazepines.
Individuals with a history of addiction to or abuse of drugs or alcohol should be under careful surveillance when receiving benzodiazepines because of the risk of habituation and dependence to such patients.
Read the entire FDA prescribing information for Prosom (Estazolam)
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