Temazepam 30mg 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 for the short-term treatment of insomnia (trouble sleeping). It belongs to a class of drugs called benzodiazepines. It works by calming your brain activity, helping you fall asleep faster and stay asleep longer.
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 medication, do not flush it down the toilet or pour it 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 normal 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 medication, do not flush it down the toilet or pour it 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 normal 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, and only when you are ready to go to sleep for a full night (7-8 hours).
- Do not take more than the prescribed dose.
- Avoid alcohol and other sedating medications while taking temazepam, as this can lead to dangerous side effects like severe drowsiness and breathing problems.
- Do not drive or operate heavy machinery after taking temazepam, as it can impair your ability to perform these tasks safely.
- Do not stop taking this medication suddenly, especially if you have been taking it regularly for more than a few days, as this can cause withdrawal symptoms. Your doctor will guide you on how to safely reduce the dose if needed.
- This medication is for short-term use (typically 7-10 days) to avoid dependence and tolerance.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
15 mg or 30 mg orally once daily at bedtime
Dose Range:
15 - 30 mg
Condition-Specific Dosing:
insomnia:
15 mg or 30 mg orally once daily at bedtime, for short-term treatment (7-10 days).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
Use with caution; consider lower initial dose (e.g., 7.5 mg) and close monitoring.
Dialysis:
Not significantly dialyzable; use with caution, monitor for increased effects.
Hepatic Impairment:
Mild:
Consider lower initial dose (e.g., 7.5 mg or 15 mg) and close monitoring.
Moderate:
Consider lower initial dose (e.g., 7.5 mg or 15 mg) and close monitoring.
Severe:
Use with extreme caution or avoid; significant impairment may prolong half-life and increase adverse effects.
Pharmacology
Mechanism of Action
Temazepam binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A receptor complex in the central nervous system. This binding enhances the inhibitory effects of gamma-aminobutyric acid (GABA), leading to increased chloride ion influx, neuronal hyperpolarization, and decreased neuronal excitability, resulting in sedative, hypnotic, anxiolytic, anticonvulsant, and muscle relaxant effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
2-3 hours
FoodEffect:
Food may delay Tmax and slightly reduce Cmax, but overall extent of absorption is not significantly affected.
Distribution:
Vd:
Approximately 1.3-1.5 L/kg
ProteinBinding:
Approximately 96%
CnssPenetration:
Yes
Elimination:
HalfLife:
8-20 hours (intermediate-acting)
Clearance:
Approximately 0.8-1.2 mL/min/kg
ExcretionRoute:
Primarily renal (80-90%), with a small amount in feces (10%)
Unchanged:
<1%
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
Serious Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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 mild 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. 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.
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 medical attention right away:
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 mild 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. 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.
Seek Immediate Medical Attention If You Experience:
- Unusual or aggressive behavior
- Confusion or memory problems (e.g., not remembering what happened after taking the pill)
- Worsening depression or suicidal thoughts
- Severe drowsiness or dizziness that doesn't go away
- Difficulty breathing or very slow, shallow breathing
- Yellowing of the skin or eyes (jaundice)
- Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, 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 and its symptoms.
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 with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all the medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose of any medication without first consulting 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 and its symptoms.
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 with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all the medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose of any medication without first 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.
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 or 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 getting up from a sitting or lying position, and exercise caution when navigating stairs.
Alcohol consumption should be avoided while taking this medication. Do not take this drug if you have consumed alcohol in the evening or before bedtime.
Before using marijuana, other cannabis products, or prescription and over-the-counter medications that can impair your reactions, consult your doctor.
This medication can cause drowsiness and reduced alertness, increasing the risk of falls. This risk is particularly higher in older adults. If you have concerns, discuss them with your doctor.
If you are 65 years or older, exercise caution when using this medication, 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. Discuss these risks 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.
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 or 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 getting up from a sitting or lying position, and exercise caution when navigating stairs.
Alcohol consumption should be avoided while taking this medication. Do not take this drug if you have consumed alcohol in the evening or before bedtime.
Before using marijuana, other cannabis products, or prescription and over-the-counter medications that can impair your reactions, consult your doctor.
This medication can cause drowsiness and reduced alertness, increasing the risk of falls. This risk is particularly higher in older adults. If you have concerns, discuss them with your doctor.
If you are 65 years or older, exercise caution when using this medication, 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. Discuss these risks 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.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or sedation
- Confusion
- Slurred speech
- Ataxia (loss of coordination)
- Slowed or shallow breathing
- Hypotension (low blood pressure)
- Coma
What to Do:
Immediately call 911 or your local emergency number. For poison control, call 1-800-222-1222. Seek immediate medical attention.
Drug Interactions
Major Interactions
- Opioids (e.g., fentanyl, oxycodone, hydrocodone): Increased risk of profound sedation, respiratory depression, coma, and death. Concomitant use should be avoided unless benefits outweigh risks, and patients should be closely monitored.
- Alcohol: Potentiation of CNS depressant effects, leading to severe sedation, respiratory depression, and impaired psychomotor function.
- Other CNS Depressants (e.g., other benzodiazepines, barbiturates, tricyclic antidepressants, antihistamines, antipsychotics, general anesthetics, muscle relaxants): Additive CNS depressant effects.
Moderate Interactions
- Antihypertensives: May cause additive hypotensive effects.
- Digoxin: Benzodiazepines may increase digoxin levels in some patients.
- Probenecid: May inhibit glucuronidation of temazepam, potentially increasing its plasma concentrations.
Monitoring
Baseline Monitoring
Sleep history and patterns
Rationale: To assess the nature and severity of insomnia and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Mental status and cognitive function
Rationale: To assess for pre-existing cognitive impairment and monitor for adverse effects like confusion or memory impairment.
Timing: Prior to initiation of therapy.
Substance use history (alcohol, illicit drugs, other CNS depressants)
Rationale: To identify risk factors for abuse, dependence, and dangerous drug interactions.
Timing: Prior to initiation of therapy.
Respiratory function (especially in patients with COPD or sleep apnea)
Rationale: To assess baseline respiratory status due to risk of respiratory depression.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (sleep quality, sleep latency, total sleep time)
Frequency: Daily during initial treatment, then periodically as needed.
Target: Improved sleep parameters, patient satisfaction.
Action Threshold: Lack of improvement or worsening of insomnia may indicate need for re-evaluation or alternative therapy.
Adverse effects (drowsiness, dizziness, ataxia, cognitive impairment, paradoxical reactions)
Frequency: Daily during initial treatment, then periodically as needed.
Target: Absence or minimal adverse effects.
Action Threshold: Significant or intolerable adverse effects warrant dose reduction or discontinuation.
Signs of dependence or withdrawal symptoms
Frequency: Periodically, especially with prolonged use or during dose reduction/discontinuation.
Target: Absence of signs of dependence or withdrawal.
Action Threshold: Presence of these signs indicates need for careful tapering or management of withdrawal.
Respiratory rate and depth (especially with concomitant opioid use)
Frequency: Closely monitor, especially during initiation or dose changes of either drug.
Target: Normal respiratory rate and effort.
Action Threshold: Bradypnea or shallow breathing requires immediate intervention.
Symptom Monitoring
- Excessive sedation
- Dizziness
- Ataxia (impaired coordination)
- Confusion
- Memory impairment (anterograde amnesia)
- Slurred speech
- Paradoxical reactions (e.g., agitation, aggression, hallucinations, worsening insomnia)
- Difficulty breathing or shallow breathing
- Signs of withdrawal upon discontinuation (e.g., rebound insomnia, anxiety, tremors, seizures)
Special Patient Groups
Pregnancy
Temazepam is contraindicated in pregnancy (Pregnancy Category X) due to potential risks to the fetus.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations (e.g., cleft lip/palate) if used during the first trimester, though data are conflicting.
Second Trimester:
Not well-studied, but continued use of benzodiazepines during pregnancy is generally discouraged.
Third Trimester:
Risk of neonatal flaccidity (floppy infant syndrome), respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., irritability, hypertonia, tremors, seizures) in the neonate if used late in pregnancy.
Lactation
Temazepam is excreted into breast milk. Use is generally not recommended due to potential for adverse effects in the nursing infant.
Infant Risk:
Risk of sedation, lethargy, poor feeding, and weight gain in the infant. Long-term effects on neurodevelopment are unknown. Monitor infant closely if use is unavoidable; consider alternative medications or temporary cessation of breastfeeding.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in children or adolescents.
Geriatric Use
Elderly patients are more sensitive to the effects of benzodiazepines and are at increased risk for adverse effects, including excessive sedation, dizziness, ataxia, falls, and cognitive impairment. A lower initial dose (e.g., 7.5 mg) is recommended, and patients should be closely monitored.
Clinical Information
Clinical Pearls
- Temazepam is an intermediate-acting benzodiazepine, making it suitable for both sleep initiation and maintenance.
- Due to its potential for dependence and withdrawal, temazepam should be used for short-term treatment of insomnia (typically 7-10 days).
- Patients should be advised to take temazepam immediately before going to bed, as it can cause rapid onset of drowsiness.
- Rebound insomnia, characterized by a temporary worsening of sleep problems, can occur upon abrupt discontinuation, especially after prolonged use. Tapering the dose gradually is recommended.
- Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, particularly in elderly or pediatric patients, or those with psychiatric disorders. Discontinue if these occur.
- The concomitant use of temazepam with opioids carries a Black Box Warning due to the risk of severe respiratory depression and death.
Alternative Therapies
- Zolpidem (Ambien)
- Eszopiclone (Lunesta)
- Zaleplon (Sonata)
- Suvorexant (Belsomra)
- Lemborexant (Dayvigo)
- Ramelteon (Rozerem)
- Doxepin (Silenor)
- Trazodone
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
Cost & Coverage
Average Cost:
$10 - $50 per 30 capsules (generic 30mg)
Generic Available:
Yes
Insurance Coverage:
Generally Tier 1 or Tier 2 for generic formulations on most commercial and Medicare Part D plans.
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.