Temazepam 22.5mg Capsules

Manufacturer MALLINCKRODT Active Ingredient Temazepam(te MAZ e pam) Pronunciation te MAZ e pam
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 treat sleep problems.
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Drug Class
Hypnotic
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Pharmacologic Class
Benzodiazepine
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Pregnancy Category
Category X
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FDA Approved
May 1981
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Temazepam is a medication used to treat insomnia, which is trouble falling or staying asleep. It belongs to a class of drugs called benzodiazepines. It works by calming your brain activity to help you fall asleep faster and stay asleep longer. It is usually taken just before bedtime.
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How to Use This Medicine

Taking Your Medication

To use this medication safely and effectively, 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. It's best to take it right before bedtime. However, make sure you have at least 7 to 8 hours available for a full night's sleep before you need to be active again. If you continue to have trouble sleeping after 7 to 10 days, contact your doctor for further guidance.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or secure area to store your medication. Keep all medications out of reach of pets. 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. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if taking the missed dose would interfere with getting at least 7 hours of sleep before being active again, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Take exactly as prescribed, usually just before going to bed, and only when you can get a full 7-8 hours of sleep.
  • Do not take more than the prescribed dose or for longer than recommended.
  • Avoid alcohol and other sedating medications while taking temazepam, as this can increase the risk of serious side effects like severe drowsiness and breathing problems.
  • Do not drive or operate heavy machinery after taking temazepam until you know how it affects you.
  • Do not stop taking temazepam suddenly, especially if you have been taking it regularly for a while, as this can cause withdrawal symptoms. Your doctor will help you gradually reduce the dose.
  • Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed).

Dosing & Administration

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Adult Dosing

Standard Dose: 22.5 mg orally once daily at bedtime for insomnia
Dose Range: 7.5 - 30 mg

Condition-Specific Dosing:

insomnia: 7.5 mg to 30 mg orally once daily at bedtime. For transient insomnia, 7.5 mg may be sufficient. For chronic insomnia, 15 mg to 30 mg is typically used. The 22.5 mg dose is an intermediate strength.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required, but monitor for increased sedation.
Moderate: No specific dose adjustment generally required, but monitor for increased sedation.
Severe: Use with caution; consider lower initial doses (e.g., 7.5 mg) and monitor closely for adverse effects due to potential accumulation of metabolites.
Dialysis: Temazepam is not significantly dialyzable. Use with caution and monitor for increased sedation.

Hepatic Impairment:

Mild: No specific dose adjustment generally required, but monitor for increased sedation.
Moderate: Use with caution; consider lower initial doses (e.g., 7.5 mg) and monitor closely for adverse effects due to impaired metabolism.
Severe: Contraindicated or use with extreme caution; significantly reduced clearance may lead to profound sedation and encephalopathy. Consider alternative therapies.

Pharmacology

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Mechanism of Action

Temazepam is a benzodiazepine that binds to stereospecific benzodiazepine receptors on the postsynaptic gamma-aminobutyric acid (GABA) A receptor complex in the central nervous system. This binding enhances the inhibitory effects of GABA by increasing chloride ion influx through the GABA-gated chloride channel, leading to hyperpolarization of the neuronal membrane and decreased neuronal excitability. This results in sedative, hypnotic, anxiolytic, anticonvulsant, and muscle relaxant properties.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: Approximately 1.5 hours (range 0.5-5 hours)
FoodEffect: Food may delay the rate of absorption (increase Tmax) but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 1.3-1.5 L/kg
ProteinBinding: Approximately 96%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 10-20 hours (mean 10 hours)
Clearance: Approximately 0.8-1.2 mL/min/kg
ExcretionRoute: Renal (urine), primarily as inactive glucuronide conjugates
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 20-40 minutes
PeakEffect: Approximately 1.5 hours
DurationOfAction: Approximately 6-8 hours (sufficient for a full night's sleep)

Safety & Warnings

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BLACK BOX WARNING

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; 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 temazepam, exposes patients to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing temazepam, assess each patient’s risk for abuse, misuse, and addiction. After initiating temazepam, monitor patients regularly for the development of these behaviors or conditions.

Continued use of benzodiazepines, including temazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher doses. Abrupt discontinuation or rapid dosage reduction of temazepam 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 temazepam or reduce the dosage.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Feeling confused or disoriented
Difficulty thinking clearly
Changes in balance
Severe dizziness or fainting
Severe stomach upset or vomiting
Engaging in activities while not fully awake, such as driving, eating, or having sex, without remembering them later

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Headache
Dizziness
Feeling sleepy or groggy the next day
Fatigue or weakness
Upset stomach
Feeling nervous or excitable

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or dizziness
  • Difficulty breathing or shallow breathing
  • Unusual thoughts or behavior (e.g., aggression, agitation, hallucinations)
  • Memory problems (not remembering what happened after taking the pill)
  • Worsening depression or suicidal thoughts
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are taking any other medications that can cause drowsiness, as there are numerous drugs that can have this effect. If you are unsure, consult your doctor or pharmacist for guidance.

Please note that this is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your existing health problems

To ensure your safety, it is vital to verify that it is acceptable to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When used nightly for more than a few weeks, sleep medications like this one may lose their effectiveness in addressing sleep issues due to the development of tolerance. Therefore, it is recommended to use this medication for a short period only. If your sleep problems persist, consult your doctor for further guidance.

To ensure your safety, avoid driving and engaging in activities that require alertness after taking this medication, as you may still experience drowsiness the day after consumption. Refrain from these activities until you feel fully awake and alert.

To minimize the risk of dizziness or fainting, stand up slowly when rising from a seated or lying position, and exercise caution when navigating stairs.

It is crucial to avoid consuming alcohol while taking this medication, and do not take it if you have had alcohol on the same evening or before bedtime. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may impair your reactions.

This medication can cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

There is a potential risk of harm to the unborn baby if this medication is taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, notify your doctor immediately. Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, low body temperature, or withdrawal symptoms in the newborn, so it is essential to discuss this with your doctor.

If you are breastfeeding or plan to breastfeed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness or sedation
  • Confusion
  • Slurred speech
  • Slowed reflexes
  • Ataxia (loss of coordination)
  • Hypotension (low blood pressure)
  • Respiratory depression (slow, shallow breathing)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Opioid analgesics (concurrent use significantly increases risk of respiratory depression, profound sedation, coma, and death)
  • Other benzodiazepines (additive CNS depression)
  • Alcohol (additive CNS depression)
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Major Interactions

  • Other CNS depressants (e.g., barbiturates, tricyclic antidepressants, antihistamines, general anesthetics, antipsychotics, skeletal muscle relaxants) - increased risk of sedation, respiratory depression.
  • Sodium oxybate - increased risk of respiratory depression and CNS depression.
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Moderate Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) - while temazepam is primarily glucuronidated, some benzodiazepines can be affected, leading to increased temazepam levels. Monitor for increased sedation.
  • Probenecid - may inhibit glucuronidation, potentially increasing temazepam levels.
  • Rifampin - may induce metabolism, potentially decreasing temazepam levels (less common due to glucuronidation).
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Minor Interactions

  • Herbal supplements with sedative properties (e.g., valerian, kava, chamomile) - additive sedative effects.

Monitoring

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Baseline Monitoring

Medical history (especially history of substance abuse, respiratory disease, depression, sleep apnea)

Rationale: To identify contraindications, risk factors for adverse effects, and potential for abuse/dependence.

Timing: Prior to initiation of therapy

Current medication list

Rationale: To identify potential drug-drug interactions, especially with other CNS depressants.

Timing: Prior to initiation of therapy

Mental status assessment

Rationale: To establish baseline cognitive function and mood.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (sleep onset, duration, quality)

Frequency: Regularly during treatment, especially during initial weeks

Target: Improved sleep parameters

Action Threshold: Lack of efficacy after appropriate trial, or worsening insomnia

Adverse effects (e.g., daytime sedation, dizziness, cognitive impairment, paradoxical reactions)

Frequency: Regularly, especially during initial weeks and with dose changes

Target: Absence or minimal tolerable side effects

Action Threshold: Significant or intolerable side effects, signs of dependence/withdrawal

Signs of abuse, misuse, or dependence

Frequency: At each follow-up visit

Target: No signs of abuse/dependence

Action Threshold: Evidence of drug-seeking behavior, escalating dose, or withdrawal symptoms upon discontinuation

Respiratory status (especially in patients with pre-existing respiratory conditions)

Frequency: As clinically indicated, particularly with co-administration of opioids or other CNS depressants

Target: Normal respiratory rate and effort

Action Threshold: Bradypnea, shallow breathing, hypoxemia

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Symptom Monitoring

  • Excessive daytime sleepiness
  • Dizziness or lightheadedness
  • Impaired coordination or ataxia
  • Memory impairment (anterograde amnesia)
  • Confusion or disorientation
  • Paradoxical reactions (e.g., excitement, aggression, hallucinations)
  • Signs of respiratory depression (slow, shallow breathing)
  • Symptoms of withdrawal upon discontinuation (e.g., rebound insomnia, anxiety, tremors, seizures)

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy (Pregnancy Category X) due to increased risk of congenital malformations (e.g., cleft lip/palate) and neonatal flaccidity, respiratory depression, and withdrawal symptoms if used during the third trimester.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate) based on some studies, though data is mixed for all benzodiazepines.
Second Trimester: Potential for fetal CNS depression if used, but less data on specific malformations.
Third Trimester: Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., irritability, hypertonia, tremors) in the neonate if used late in pregnancy.
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Lactation

Not recommended during breastfeeding (Lactation Risk L3 - Moderate Concern). Temazepam is excreted into breast milk and can cause sedation, poor feeding, and weight loss in the infant. Monitor the infant for drowsiness, feeding difficulties, and developmental milestones.

Infant Risk: Moderate risk. Potential for sedation, lethargy, poor feeding, and weight gain issues in the breastfed infant. Long-term effects are unknown. Consider alternative therapies or monitor infant closely.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Not recommended for use in individuals under 18 years of age.

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Geriatric Use

Elderly patients are more sensitive to the effects of benzodiazepines and are at increased risk for adverse effects such as sedation, dizziness, falls, and cognitive impairment. Lower initial doses (e.g., 7.5 mg) are recommended, and patients should be closely monitored. Avoid higher doses.

Clinical Information

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Clinical Pearls

  • Temazepam is an intermediate-acting benzodiazepine, making it suitable for sleep maintenance as well as sleep onset.
  • Due to its primary metabolism via glucuronidation, it has fewer significant drug interactions compared to benzodiazepines metabolized by CYP450 enzymes.
  • Always emphasize the importance of taking temazepam only when a full night's sleep (7-8 hours) is possible to avoid residual daytime sedation.
  • Educate patients on the risks of dependence, abuse, and withdrawal, and the importance of gradual tapering when discontinuing.
  • Counsel patients on the severe risks of co-administration with opioids and alcohol.
  • Consider non-pharmacological interventions (CBT-I) as first-line for chronic insomnia before initiating hypnotics.
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Alternative Therapies

  • Other benzodiazepine receptor agonists (BZRAs): Zolpidem (Ambien), Eszopiclone (Lunesta), Zaleplon (Sonata)
  • Melatonin receptor agonists: Ramelteon (Rozerem)
  • Orexin receptor antagonists: Suvorexant (Belsomra), Lemborexant (Dayvigo)
  • Antidepressants with sedative properties (off-label for insomnia): Trazodone, Mirtazapine, Doxepin (Silenor)
  • Antihistamines (OTC): Diphenhydramine, Doxylamine
  • Cognitive Behavioral Therapy for Insomnia (CBT-I) - often considered first-line non-pharmacological treatment.
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.