Temazepam 15mg Capsules
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.
Drug Class
Sedative-Hypnotic
Pharmacologic Class
Benzodiazepine
Pregnancy Category
Category X
FDA Approved
May 1981
DEA Schedule
Schedule IV
Overview
What is this medicine?
Temazepam is a medication used to treat insomnia (difficulty falling or staying asleep). It belongs to a class of drugs called benzodiazepines. It works by slowing down brain activity, which helps you feel calm and sleepy.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and do so right before bedtime. It's essential to take this medication only when you can get a full night's sleep, which is at least 7 to 8 hours, 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 storage in a 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 area to secure your medication. Keep all medications away from pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for the best disposal method, and check if there are any drug take-back programs in your area.
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 not allow for a full night's sleep (at least 7 hours) before you need to be active, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and do so right before bedtime. It's essential to take this medication only when you can get a full night's sleep, which is at least 7 to 8 hours, 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 storage in a 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 area to secure your medication. Keep all medications away from pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for the best disposal method, and check if there are any drug take-back programs in your area.
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 not allow for a full night's sleep (at least 7 hours) before you need to be active, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Take exactly as prescribed, usually just before bedtime.
- Do not take more than the prescribed dose or for longer than recommended.
- Avoid alcohol and other CNS depressants (e.g., pain medications, cold medicines, other sedatives) while taking temazepam, as this can increase the risk of serious side effects like severe drowsiness and breathing problems.
- Do not drive or operate machinery after taking temazepam, as it can impair your ability to perform these tasks safely.
- Do not stop taking temazepam suddenly, especially if you have been taking it regularly for more than a few days, as this can lead to withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose.
- Report any unusual thoughts or behaviors (e.g., aggression, hallucinations, sleep-driving) to your doctor immediately.
- Ensure you have at least 7-8 hours available for sleep after taking the medication to minimize residual drowsiness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
15 mg orally at bedtime as needed
Dose Range:
7.5 - 30 mg
Condition-Specific Dosing:
elderlyOrDebilitated:
7.5 mg orally at bedtime initially
severeInsomnia:
30 mg orally at bedtime
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, use with caution
Moderate:
No specific adjustment, use with caution
Severe:
Use with caution, consider lower doses
Dialysis:
Not significantly dialyzable; use with caution, monitor for increased effects
Hepatic Impairment:
Mild:
Use with caution, consider lower doses
Moderate:
Use with caution, consider lower doses
Severe:
Contraindicated or use with extreme caution, significant dose reduction may be necessary
Pharmacology
Mechanism of Action
Temazepam binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron in the central nervous system, including the limbic system, reticular formation, and thalamus. 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 sedative, hypnotic, anxiolytic, anticonvulsant, and muscle relaxant properties.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
2-3 hours
FoodEffect:
Food may delay absorption and peak plasma concentrations, but does not significantly affect the extent of absorption.
Distribution:
Vd:
Approximately 1.3-1.5 L/kg
ProteinBinding:
Approximately 96%
CnssPenetration:
Yes
Elimination:
HalfLife:
8-20 hours (mean 10 hours)
Clearance:
Not available
ExcretionRoute:
Primarily renal (approximately 80% as conjugated metabolites, 10% as unchanged drug)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
20-40 minutes
PeakEffect:
2-3 hours
DurationOfAction:
6-8 hours
Safety & Warnings
BLACK BOX WARNING
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.
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 symptoms that bother you or do not go away, contact your doctor:
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. 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.
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 symptoms that bother you or do not go away, contact your doctor:
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. 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
- Difficulty breathing or shallow breathing
- Unusual confusion or disorientation
- Memory problems (especially after taking the dose)
- Hallucinations or unusual thoughts
- Aggression or agitation
- Worsening of depression or suicidal thoughts
- Yellowing of skin or eyes (jaundice)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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. Only resume these activities when you feel fully awake and alert.
To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when navigating stairs.
Refrain from consuming alcohol while taking this medication, and do not take it if you have had alcohol that 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. Consult your doctor to discuss the potential risks.
If you are breastfeeding or plan to breastfeed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
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. Only resume these activities when you feel fully awake and alert.
To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when navigating stairs.
Refrain from consuming alcohol while taking this medication, and do not take it if you have had alcohol that 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. Consult your doctor to discuss the potential risks.
If you are breastfeeding or plan to breastfeed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
Overdose Information
Overdose Symptoms:
- Extreme drowsiness
- Confusion
- Slurred speech
- Slowed reflexes
- Lack of coordination (ataxia)
- 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. Flumazenil may be used as an antidote in severe cases, but it carries risks, especially in patients with benzodiazepine dependence.
Drug Interactions
Contraindicated Interactions
- Opioids (due to risk of profound sedation, respiratory depression, coma, and death)
- Severe respiratory insufficiency
- Acute narrow-angle glaucoma (relative contraindication, use with caution)
Major Interactions
- Alcohol
- Other CNS depressants (e.g., barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics, general anesthetics)
- Sodium oxybate
Moderate Interactions
- Antihypertensives (may cause additive hypotensive effects)
- Muscle relaxants (may cause additive CNS depression)
- Digoxin (may increase digoxin levels, monitor)
- Probenecid (may increase temazepam levels by inhibiting glucuronidation)
Minor Interactions
- Theophylline/Aminophylline (may antagonize sedative effects of benzodiazepines)
Monitoring
Baseline Monitoring
Sleep history and underlying cause of insomnia
Rationale: To determine appropriateness of therapy and identify treatable causes of insomnia.
Timing: Prior to initiation of therapy
Mental status and cognitive function
Rationale: To assess baseline and monitor for cognitive impairment or paradoxical reactions.
Timing: Prior to initiation of therapy
Respiratory function
Rationale: To assess for pre-existing respiratory compromise, especially in patients with COPD or sleep apnea.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy of sleep induction/maintenance
Frequency: Periodically, especially during initial weeks of therapy and at follow-up visits
Target: Improved sleep onset, duration, and quality
Action Threshold: Lack of efficacy after 7-10 days may indicate need for re-evaluation of insomnia cause or treatment plan.
Adverse effects (e.g., drowsiness, dizziness, ataxia, cognitive impairment)
Frequency: Regularly, especially during initial weeks and with dose adjustments
Target: Minimization of side effects
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Signs of dependence or withdrawal
Frequency: Periodically, especially with long-term use
Target: Absence of drug-seeking behavior, tolerance, or withdrawal symptoms upon dose reduction/discontinuation
Action Threshold: Presence of these signs indicates need for careful tapering or re-evaluation.
Respiratory status (especially in patients with respiratory compromise)
Frequency: As clinically indicated
Target: Stable respiratory rate and oxygen saturation
Action Threshold: Signs of respiratory depression (e.g., bradypnea, hypoxemia) require immediate intervention.
Symptom Monitoring
- Excessive daytime drowsiness
- Dizziness
- Lightheadedness
- Ataxia (impaired coordination)
- Confusion
- Memory impairment (anterograde amnesia)
- 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
Pregnancy
Temazepam is classified as Pregnancy Category X. It is contraindicated in pregnancy due to evidence of fetal risk. Benzodiazepines can cause congenital malformations, particularly during the first trimester. Use during the third trimester or near delivery can lead to 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression) and neonatal withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations (e.g., cleft lip/palate, cardiac anomalies) based on some studies, though data are conflicting. Avoid use.
Second Trimester:
Limited data, but continued use may contribute to fetal exposure and potential for adverse effects.
Third Trimester:
Risk of 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression) and neonatal withdrawal syndrome (irritability, hypertonia, tremors, feeding difficulties) if used near term.
Lactation
Temazepam is excreted into breast milk. The American Academy of Pediatrics considers it to have an unknown effect on the nursing infant but may be of concern. Monitor the infant for sedation, poor feeding, and weight gain. Use with caution, or consider an alternative drug with less excretion into milk or a shorter half-life.
Infant Risk:
Moderate concern (L3). Potential for sedation, lethargy, poor feeding, and weight loss in the infant. Long-term effects are unknown.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in children under 18 years of age due to lack of data and potential for adverse effects.
Geriatric Use
Elderly patients are more sensitive to the effects of benzodiazepines and are at increased risk of adverse effects, including excessive sedation, dizziness, ataxia, falls, and cognitive impairment. Start with the lowest effective dose (e.g., 7.5 mg) and titrate carefully. Monitor closely for CNS depression and falls.
Clinical Information
Clinical Pearls
- Temazepam is an intermediate-acting benzodiazepine, making it suitable for sleep initiation and maintenance with less residual daytime sedation compared to longer-acting agents.
- Due to its primary metabolism via glucuronidation (Phase II), temazepam has fewer significant drug-drug interactions related to CYP450 enzymes compared to benzodiazepines metabolized by oxidation (Phase I).
- Tolerance and physical dependence can develop with regular use, even at therapeutic doses. It is generally recommended for short-term use (7-10 days) for insomnia.
- Rebound insomnia and withdrawal symptoms can occur upon abrupt discontinuation, especially after prolonged use. Tapering the dose gradually is crucial.
- Patients should be advised to take temazepam immediately before going to bed, as it has a relatively rapid onset of action, and to ensure they have a full night's sleep (7-8 hours) to avoid next-day impairment.
Alternative Therapies
- Other benzodiazepine receptor agonists (e.g., zolpidem, zaleplon, eszopiclone)
- Other benzodiazepines (e.g., triazolam, estazolam, flurazepam)
- Melatonin receptor agonists (e.g., ramelteon)
- Orexin receptor antagonists (e.g., suvorexant, lemborexant)
- Antidepressants with sedative properties (e.g., trazodone, mirtazapine, doxepin)
- Antihistamines (e.g., diphenhydramine, hydroxyzine)
- Non-pharmacological treatments (e.g., Cognitive Behavioral Therapy for Insomnia (CBT-I), sleep hygiene practices, relaxation techniques)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 capsules (15mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.