Diazepam 5mg/5ml (1mg/1ml) Oral Sol
WARNING: This drug is a benzodiazepine. The use of a benzodiazepine drug along with opioid drugs has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and death. Opioid drugs include drugs like codeine, oxycodone, and morphine. Opioid drugs are used to treat pain and some are used to treat cough. Talk with the doctor.If you are taking this drug with an opioid drug, get medical help right away if you feel very sleepy or dizzy; if you have slow, shallow, or trouble breathing; or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up. Benzodiazepines can put you at risk for drug use disorder. Misuse or abuse of this drug can lead to overdose or death, especially when used along with certain other drugs, alcohol, or street drugs. Drug use disorder can happen even if you take this drug as your doctor has told you. Get medical help right away if you have changes in mood or behavior, suicidal thoughts or actions, seizures, or trouble breathing.You will be watched closely to make sure you do not misuse this drug or develop drug use disorder.Benzodiazepines may cause dependence. Lowering the dose or stopping this drug all of a sudden may cause withdrawal. This can be life- threatening. The risk of dependence and withdrawal are raised the longer you take this drug and the higher the dose. Talk to your doctor before you lower the dose or stop this drug. You will need to follow your doctor's instructions. Get medical help right away if you have trouble controlling body movements, seizures, new or worse behavior or mood changes like depression or thoughts of suicide, thoughts of harming someone, hallucinations (seeing or hearing things that are not there), losing contact with reality, moving around or talking a lot, or any other bad effects.Sometimes, withdrawal signs can last for several weeks to more than 12 months. Tell your doctor if you have anxiety; trouble with memory, learning, or focusing; trouble sleeping; burning, numbness, or tingling; weakness; shaking; muscle twitching; ringing in the ears; or any other bad effects. @ COMMON USES: It is used to relax muscles.It is used to treat alcohol withdrawal.It is used to treat anxiety.It is used to help control certain kinds of seizures.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anxiolytic; Sedative-hypnotic; Anticonvulsant; Skeletal muscle relaxant
Pharmacologic Class
Benzodiazepine
Pregnancy Category
Category D
FDA Approved
Nov 1963
DEA Schedule
Schedule IV
Overview
What is this medicine?
Diazepam is a medication that belongs to a class of drugs called benzodiazepines. It works by calming the brain and nerves. It is used to treat anxiety, muscle spasms, and seizures, and to help with alcohol withdrawal symptoms.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
When taking the liquid form of this medication, make sure you have the correct strength and measure the dose carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one. Do not use a household teaspoon or tablespoon to measure your dose, as this could result in taking too much medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in a bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or area to keep your medication out of reach.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
If you take this medication as needed, do not take it more frequently than directed by your doctor. Always follow your doctor's instructions for taking your medication to ensure safe and effective use.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
When taking the liquid form of this medication, make sure you have the correct strength and measure the dose carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one. Do not use a household teaspoon or tablespoon to measure your dose, as this could result in taking too much medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in a bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or area to keep your medication out of reach.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
If you take this medication as needed, do not take it more frequently than directed by your doctor. Always follow your doctor's instructions for taking your medication to ensure safe and effective use.
Lifestyle & Tips
- Do not drink alcohol or use other drugs that make you drowsy while taking diazepam, as this can increase the risk of serious side effects like severe drowsiness or breathing problems.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Do not stop taking this medication suddenly, especially if you have been taking it for a long time. Your doctor will tell you how to slowly reduce your dose to prevent withdrawal symptoms.
- Store the oral solution at room temperature, away from light and moisture. Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
- Diazepam 2mg Tablets
- Diazepam 5mg Tablets
- Diazepam 10mg Tablets
- Diazepam 5mg/5ml (1mg/1ml) Oral Sol
- Diazepam 5mg/1ml Oral Concentrate
- Diazepam 5mg/ml Inj, 2ml
- Diazepam 5mg/ml Inj, 10ml
- Diazepam 20mg Rectal Gel
- Diazepam 10mg Rectal Gel( 2 Pack)
- Diazepam 2.5mg Rectal Gel (2 Pack)
- Diazepam 5mg/ml Inj, 2ml
- Diazepam 10mg Rectal Gel (2 Pack)
- Diazepam 20mg Rectal Gel
- Diazepam 10mg/2ml Inj, 2ml
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For anxiety: 2-10 mg, 2-4 times daily. For acute alcohol withdrawal: 10 mg, 3-4 times daily for first 24 hours, then 5 mg, 3-4 times daily as needed. For muscle spasm: 2-10 mg, 3-4 times daily. For adjunctive seizure therapy: 2-10 mg, 2-4 times daily.
Dose Range:
2 - 40 mg
Condition-Specific Dosing:
anxiety:
2-10 mg, 2-4 times daily
alcohol_withdrawal:
10 mg, 3-4 times daily initially, then 5 mg, 3-4 times daily
muscle_spasm:
2-10 mg, 3-4 times daily
adjunctive_seizure_therapy:
2-10 mg, 2-4 times daily
Pediatric Dosing
Neonatal:
Not established (contraindicated in infants <30 days due to risk of kernicterus)
Infant:
Not established for routine use (<6 months). For 6 months and older: 1-2.5 mg, 3-4 times daily, titrate as needed.
Child:
For anxiety, muscle spasm, adjunctive seizure therapy (6 months and older): 1-2.5 mg, 3-4 times daily, titrate as needed. Max 10 mg/day.
Adolescent:
Similar to adult dosing, starting with lower end of range (2-5 mg, 2-4 times daily) and titrating.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, use with caution.
Moderate:
No specific adjustment, use with caution and monitor for increased sedation.
Severe:
Use with caution, monitor closely for increased and prolonged effects due to potential accumulation of active metabolites.
Dialysis:
Not significantly dialyzable; no supplemental dose needed post-dialysis. Use with caution.
Hepatic Impairment:
Mild:
Use with caution, consider lower doses.
Moderate:
Reduce dose by 50% or use lower end of the dosing range. Monitor closely for adverse effects.
Severe:
Contraindicated due to risk of precipitating hepatic encephalopathy and prolonged elimination half-life.
Pharmacology
Mechanism of Action
Diazepam binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron at several sites within the central nervous system, including the limbic system, reticular formation, and cerebral cortex. This binding enhances the inhibitory effects of gamma-aminobutyric acid (GABA), leading to increased chloride ion influx, hyperpolarization of the neuronal membrane, and decreased neuronal excitability. This results in anxiolytic, sedative, hypnotic, muscle relaxant, and anticonvulsant effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90% (oral)
Tmax:
1-1.5 hours (oral solution may be slightly faster than tablets)
FoodEffect:
Food can delay the rate of absorption (Tmax) but generally does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
0.8-1 L/kg (increases with age and liver disease)
ProteinBinding:
Approximately 98% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
Diazepam: 20-100 hours (highly variable, longer in elderly and liver disease); Desmethyldiazepam: 30-100 hours; Temazepam: 10-20 hours; Oxazepam: 5-15 hours.
Clearance:
0.2-0.5 mL/min/kg
ExcretionRoute:
Primarily renal (urine) as conjugated metabolites; <1% excreted unchanged.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
15-60 minutes (oral)
PeakEffect:
1-1.5 hours
DurationOfAction:
3-8 hours (clinical effects), but accumulation due to long-acting metabolites can lead to prolonged effects.
Safety & Warnings
BLACK BOX WARNING
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND PHYSICAL DEPENDENCE AND WITHDRAWAL REACTIONS.
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
The use of benzodiazepines, including diazepam, exposes patients and other users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing diazepam and throughout treatment, assess each patient’s risk of abuse, misuse, and addiction.
The continued use of benzodiazepines, including diazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of diazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam or reduce the dosage.
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
The use of benzodiazepines, including diazepam, exposes patients and other users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing diazepam and throughout treatment, assess each patient’s risk of abuse, misuse, and addiction.
The continued use of benzodiazepines, including diazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of diazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam or reduce the dosage.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Change in balance
Feeling confused
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Severe dizziness or fainting
Muscle spasms
Twitching
Trouble sleeping
Changes in eyesight
Slurred speech
Severe upset stomach, vomiting, or loss of appetite that persists
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal behavior. Seek immediate medical attention if you experience:
+ New or worsening symptoms of depression
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Other changes in mood or behavior
+ Suicidal thoughts or actions
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Feeling sleepy
Feeling tired or weak
* Muscle weakness
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Change in balance
Feeling confused
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Severe dizziness or fainting
Muscle spasms
Twitching
Trouble sleeping
Changes in eyesight
Slurred speech
Severe upset stomach, vomiting, or loss of appetite that persists
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal behavior. Seek immediate medical attention if you experience:
+ New or worsening symptoms of depression
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Other changes in mood or behavior
+ Suicidal thoughts or actions
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Feeling sleepy
Feeling tired or weak
* Muscle weakness
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or sedation that makes it difficult to wake up
- Difficulty breathing or shallow breathing
- Yellowing of the skin or eyes (jaundice)
- Severe skin rash or itching
- Unusual changes in mood or behavior (e.g., agitation, aggression, hallucinations, restlessness)
- Slurred speech or difficulty speaking
- Loss of coordination or balance (ataxia)
- Seizures (if stopping abruptly after long-term use)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Breathing problems
+ Glaucoma
+ Liver disease
+ Myasthenia gravis
+ Sleep apnea
If you have a history of psychosis
Recent consumption of large amounts of alcohol or use of medications that may impair your reactions, such as phenobarbital or certain pain medications like oxycodone
If you are breastfeeding or plan to breastfeed, as you may need to avoid nursing
Special Considerations for Children:
If the patient is under 6 months of age, do not administer this medication, as it is not suitable for infants younger than 6 months.
To ensure your safety, it is crucial to disclose all of the following to your doctor and pharmacist:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
* Any health problems you have
This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Breathing problems
+ Glaucoma
+ Liver disease
+ Myasthenia gravis
+ Sleep apnea
If you have a history of psychosis
Recent consumption of large amounts of alcohol or use of medications that may impair your reactions, such as phenobarbital or certain pain medications like oxycodone
If you are breastfeeding or plan to breastfeed, as you may need to avoid nursing
Special Considerations for Children:
If the patient is under 6 months of age, do not administer this medication, as it is not suitable for infants younger than 6 months.
To ensure your safety, it is crucial to disclose all of the following to your doctor and pharmacist:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
* Any health problems you have
This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.
Refrain from consuming alcohol while taking this drug, as it may exacerbate its effects.
Prior to using marijuana, other forms of cannabis, or prescription and over-the-counter medications that may impair your reactions, consult with your doctor.
If you experience a change in the frequency or severity of seizures after initiating this medication, notify your doctor promptly.
This medication may cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns, discuss them with your doctor.
Do not alter the dosage or discontinue this medication without consulting your doctor, as this may lead to seizures.
If you are taking this medication for an extended period, your doctor may recommend regular blood tests to monitor your condition.
Long-term use or high doses of this medication may result in tolerance, reducing its effectiveness and potentially requiring increased doses to achieve the same therapeutic effect. If you suspect this medication is no longer working effectively, contact your doctor. Do not exceed the prescribed dosage.
Adults 65 years and older should exercise caution when taking this medication, as they may be more susceptible to side effects.
When administering this medication to children, use caution, as they may be at a higher risk of experiencing certain side effects.
If you are pregnant or become pregnant while taking this medication, inform your doctor immediately, as it may pose a risk to the unborn baby.
Taking this medication during late pregnancy may increase the risk of respiratory or feeding problems, hypothermia, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.
Refrain from consuming alcohol while taking this drug, as it may exacerbate its effects.
Prior to using marijuana, other forms of cannabis, or prescription and over-the-counter medications that may impair your reactions, consult with your doctor.
If you experience a change in the frequency or severity of seizures after initiating this medication, notify your doctor promptly.
This medication may cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns, discuss them with your doctor.
Do not alter the dosage or discontinue this medication without consulting your doctor, as this may lead to seizures.
If you are taking this medication for an extended period, your doctor may recommend regular blood tests to monitor your condition.
Long-term use or high doses of this medication may result in tolerance, reducing its effectiveness and potentially requiring increased doses to achieve the same therapeutic effect. If you suspect this medication is no longer working effectively, contact your doctor. Do not exceed the prescribed dosage.
Adults 65 years and older should exercise caution when taking this medication, as they may be more susceptible to side effects.
When administering this medication to children, use caution, as they may be at a higher risk of experiencing certain side effects.
If you are pregnant or become pregnant while taking this medication, inform your doctor immediately, as it may pose a risk to the unborn baby.
Taking this medication during late pregnancy may increase the risk of respiratory or feeding problems, hypothermia, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or sedation
- Confusion
- Slurred speech
- Slowed or shallow breathing
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Ataxia (loss of coordination)
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose management may include supportive care, airway management, and administration of flumazenil (a benzodiazepine antagonist) in specific cases, though flumazenil carries risks.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole) - use with extreme caution or avoid due to increased diazepam levels and risk of profound sedation/respiratory depression.
- Opioids (concomitant use significantly increases risk of respiratory depression, profound sedation, coma, and death).
Major Interactions
- Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics, general anesthetics) - increased risk of additive CNS depression, respiratory depression, hypotension.
- CYP3A4 and CYP2C19 inhibitors (e.g., fluoxetine, fluvoxamine, omeprazole, cimetidine, grapefruit juice) - may significantly increase diazepam levels and prolong its effects.
- Sodium oxybate - concomitant use is contraindicated.
Moderate Interactions
- CYP inducers (e.g., carbamazepine, phenytoin, rifampin) - may decrease diazepam levels and efficacy.
- Antacids - may delay the rate of diazepam absorption but generally not the extent.
- Digoxin - may increase digoxin serum concentrations.
Minor Interactions
- Theophylline - may antagonize the sedative effects of benzodiazepines.
Monitoring
Baseline Monitoring
Liver function tests (LFTs)
Rationale: Diazepam is extensively metabolized by the liver; hepatic impairment can prolong its half-life and increase adverse effects.
Timing: Prior to initiation, especially in patients with suspected hepatic dysfunction.
Renal function (BUN, creatinine)
Rationale: Although primarily metabolized by the liver, metabolites are renally excreted. Severe renal impairment may lead to accumulation of metabolites.
Timing: Prior to initiation, especially in patients with suspected renal dysfunction.
Respiratory rate and depth
Rationale: To assess baseline respiratory status, especially important before initiating therapy in patients with respiratory compromise.
Timing: Prior to initiation.
Mental status and level of consciousness
Rationale: To establish baseline cognitive function and assess for pre-existing sedation or confusion.
Timing: Prior to initiation.
Routine Monitoring
Sedation level (e.g., using RASS or Ramsay Sedation Scale)
Frequency: Daily or as clinically indicated, especially during dose titration.
Target: Appropriate level of anxiolysis/sedation without excessive drowsiness or respiratory depression.
Action Threshold: Excessive sedation, somnolence, or unresponsiveness warrants dose reduction or discontinuation.
Respiratory rate and oxygen saturation
Frequency: Regularly, especially during initiation or dose increases, and with concomitant opioid use.
Target: Normal respiratory rate (e.g., 12-20 breaths/min for adults), SpO2 >92%.
Action Threshold: Bradypnea (<10 breaths/min), shallow breathing, or SpO2 <90% requires immediate intervention.
Blood pressure and heart rate
Frequency: Periodically, especially in patients prone to hypotension.
Target: Within patient's normal range.
Action Threshold: Significant hypotension or bradycardia.
Mental status (e.g., orientation, memory, cognitive function)
Frequency: Regularly, especially in elderly patients or those on long-term therapy.
Target: Improved anxiety/symptoms without significant cognitive impairment.
Action Threshold: Increased confusion, disorientation, or paradoxical agitation.
Signs of tolerance, dependence, or withdrawal
Frequency: Throughout therapy, particularly with long-term use.
Target: Absence of withdrawal symptoms upon dose reduction or discontinuation.
Action Threshold: Emergence of anxiety, insomnia, tremors, seizures, or other withdrawal symptoms upon dose reduction or discontinuation.
Symptom Monitoring
- Excessive drowsiness
- Dizziness
- Confusion
- Ataxia (loss of coordination)
- Slurred speech
- Difficulty breathing or shallow breathing
- Paradoxical reactions (e.g., agitation, aggression, hallucinations, restlessness)
- Muscle weakness
- Blurred vision
- Nausea/vomiting
- Skin rash or itching
- Signs of withdrawal (e.g., anxiety, insomnia, tremors, sweating, seizures) if discontinued abruptly
Special Patient Groups
Pregnancy
Diazepam is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is evidence of human fetal risk.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations, particularly cleft lip and palate, if used during the first trimester.
Second Trimester:
Potential for fetal central nervous system depression.
Third Trimester:
Risk of neonatal withdrawal syndrome (irritability, hypertonia, tremors, feeding difficulties) if used chronically during the third trimester. Risk of 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression) if used shortly before or during labor.
Lactation
Diazepam and its active metabolites are excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on nursing infants is unknown but may be of concern. Use with caution.
Infant Risk:
L3 (Moderate risk). Potential for sedation, lethargy, poor feeding, and weight loss in the breastfed infant. Monitor infants for drowsiness, poor suckling, and developmental delays. Consider alternative agents or temporary cessation of breastfeeding.
Pediatric Use
Use with caution, especially in infants and young children, due to increased sensitivity to CNS depressant effects and potential for paradoxical reactions (e.g., hyperactivity, agitation). Dosing must be carefully individualized and monitored. Contraindicated in infants less than 30 days old due to risk of kernicterus.
Geriatric Use
Elderly patients are more sensitive to the effects of benzodiazepines and are at increased risk for adverse effects, including sedation, dizziness, ataxia, falls, and cognitive impairment. Lower initial doses are recommended, and careful titration is necessary. Long half-life and active metabolites can lead to accumulation.
Clinical Information
Clinical Pearls
- Diazepam has a long elimination half-life and active metabolites, leading to drug accumulation with repeated dosing, especially in elderly patients or those with hepatic impairment.
- Due to its potential for physical dependence and withdrawal, diazepam should be tapered slowly when discontinuing, especially after prolonged use, to minimize withdrawal symptoms (e.g., anxiety, insomnia, tremors, seizures).
- Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, particularly in pediatric and geriatric patients, or those with psychiatric disorders.
- The oral solution formulation allows for flexible dosing and may be preferred for patients who have difficulty swallowing tablets or require precise dose adjustments.
- Concurrent use with opioids carries a Black Box Warning due to the risk of profound sedation, respiratory depression, coma, and death. Avoid concomitant use if possible, or use the lowest effective doses for the shortest duration, and monitor closely.
Alternative Therapies
- Other benzodiazepines (e.g., Lorazepam, Alprazolam, Clonazepam) for anxiety or seizures.
- Buspirone for generalized anxiety disorder (non-benzodiazepine).
- SSRIs/SNRIs (e.g., Sertraline, Escitalopram, Venlafaxine) for anxiety disorders.
- Hydroxyzine for anxiety (antihistamine with sedative properties).
- Baclofen or Tizanidine for muscle spasms.
- Gabapentin or Pregabalin for anxiety or neuropathic pain.
- Various other anticonvulsants (e.g., Levetiracetam, Valproic acid, Phenytoin) for seizure disorders.
Cost & Coverage
Average Cost:
$15 - $50 per 150ml of 5mg/5ml oral solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.