Temazepam 7.5mg 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 calming your brain activity to help 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 of 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 the bathroom. Keep it in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to ensure the medication's safety. 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 guidance on 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 of at least 7 hours, 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.
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 of 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 the bathroom. Keep it in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to ensure the medication's safety. 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 guidance on 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 of at least 7 hours, 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.
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 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 this medication until you know how it affects you.
- Do not stop taking this medication suddenly, especially if you have been taking it regularly, as this can cause withdrawal symptoms. Your doctor will guide you on how to safely reduce the dose.
- This medication is typically for short-term use (7-10 days) to avoid dependence and tolerance.
- Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
7.5 mg or 15 mg orally once daily at bedtime for insomnia
Dose Range:
7.5 - 30 mg
Condition-Specific Dosing:
initial_dose:
7.5 mg for elderly or debilitated patients
severe_insomnia:
Up to 30 mg may be required for some patients
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in patients <18 years)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for increased sensitivity.
Moderate:
No specific dose adjustment recommended, but monitor for increased sensitivity.
Severe:
Use with caution; consider lower doses (e.g., 7.5 mg) and monitor for prolonged effects.
Dialysis:
Not significantly dialyzable; use with caution and monitor for prolonged effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor for increased sensitivity.
Moderate:
Use with caution; consider lower doses (e.g., 7.5 mg) and monitor for prolonged effects due to impaired metabolism.
Severe:
Contraindicated or use with extreme caution; significant dose reduction (e.g., 7.5 mg) and close monitoring are necessary due to risk of hepatic encephalopathy and prolonged sedation.
Pharmacology
Mechanism of Action
Temazepam, a benzodiazepine, binds to specific benzodiazepine receptors on the gamma-aminobutyric acid (GABA)-A receptor complex in the central nervous system. This binding enhances the inhibitory effects of GABA by increasing the frequency of chloride channel opening, leading to neuronal hyperpolarization and reduced 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 the rate of absorption (increase Tmax) but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
1.3-1.5 L/kg
ProteinBinding:
Approximately 96%
CnssPenetration:
Yes
Elimination:
HalfLife:
8-20 hours (mean 10 hours)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 80-90% as glucuronide conjugates)
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
2-3 hours (for peak plasma concentration, hypnotic effect may be earlier)
DurationOfAction:
Approximately 6-8 hours (hypnotic effect)
Confidence:
Medium
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 and 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. The 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 daily dose. 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.
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
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 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
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 dizziness
- Difficulty breathing or shallow breathing
- Unusual thoughts or behavior (e.g., aggression, agitation, hallucinations)
- Memory problems (not remembering events after taking the pill)
- Worsening insomnia or new sleep problems
- Signs of an allergic reaction (e.g., 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, 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 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.
Share any health problems you have, as they may interact with this medication.
* Verify that it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any drug. Always consult your doctor before making any changes to your medication regimen.
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 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.
Share any health problems you have, as they may interact with this medication.
* Verify that it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any drug. Always consult your doctor before making any changes to your medication regimen.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When using sleep medications like this one for more than a few weeks on a nightly basis, they may lose their effectiveness in addressing sleep issues due to the development of tolerance. Therefore, it is recommended to use sleep medications for short periods only. If your sleep problems persist, consult your doctor for further guidance.
To ensure your safety, avoid operating a vehicle or engaging in any activities that require alertness after taking this medication, as it may cause drowsiness that can persist into the next day. Refrain from such 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 any prescription or over-the-counter medications that can impair your physical or mental 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 any 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 suspect you are pregnant while taking this drug, notify your doctor immediately.
Taking this medication in the late stages of pregnancy may increase the risk of respiratory or feeding difficulties, 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 using sleep medications like this one for more than a few weeks on a nightly basis, they may lose their effectiveness in addressing sleep issues due to the development of tolerance. Therefore, it is recommended to use sleep medications for short periods only. If your sleep problems persist, consult your doctor for further guidance.
To ensure your safety, avoid operating a vehicle or engaging in any activities that require alertness after taking this medication, as it may cause drowsiness that can persist into the next day. Refrain from such 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 any prescription or over-the-counter medications that can impair your physical or mental 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 any 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 suspect you are pregnant while taking this drug, notify your doctor immediately.
Taking this medication in the late stages of pregnancy may increase the risk of respiratory or feeding difficulties, 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:
- Extreme drowsiness
- Confusion
- Slurred speech
- Slowed reflexes
- Lack of coordination
- Limp muscles
- Slowed or stopped breathing
- Coma
What to Do:
If you suspect an overdose, seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Opioid analgesics (due to risk of profound sedation, respiratory depression, coma, and death)
- Alcohol (due to additive CNS depressant effects)
Major Interactions
- Other CNS depressants (e.g., barbiturates, antihistamines, antipsychotics, tricyclic antidepressants, anxiolytics, general anesthetics, skeletal muscle relaxants) - increased risk of sedation, respiratory depression, and hypotension.
- Sodium oxybate (additive CNS depression)
Moderate Interactions
- Drugs that inhibit glucuronidation (e.g., valproic acid, probenecid) - may theoretically increase temazepam levels, though less significant for temazepam than for other benzodiazepines primarily metabolized by CYP enzymes.
- Cimetidine (may slightly increase temazepam levels, but generally not clinically significant due to temazepam's primary glucuronidation pathway).
Minor Interactions
- Not available
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 examination
Rationale: To assess baseline cognitive function and identify any pre-existing psychiatric conditions.
Timing: Prior to initiation of therapy
Respiratory function
Rationale: To assess risk of respiratory depression, especially in patients with pre-existing respiratory compromise (e.g., sleep apnea, COPD).
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (sleep onset, duration, quality)
Frequency: Regularly during therapy, especially during initial weeks
Target: Improved sleep parameters, reduced nocturnal awakenings
Action Threshold: Lack of improvement or worsening insomnia may indicate need for re-evaluation or alternative therapy.
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 adverse effects
Action Threshold: Significant or bothersome 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: Development of dependence or withdrawal symptoms necessitates careful tapering.
Respiratory status (especially with concomitant opioid use or respiratory compromise)
Frequency: As clinically indicated
Target: Normal respiratory rate and effort
Action Threshold: Bradypnea, shallow breathing, or hypoxemia requires immediate medical attention.
Symptom Monitoring
- Daytime drowsiness
- Dizziness
- Lightheadedness
- Impaired coordination
- Memory problems (anterograde amnesia)
- Confusion
- Paradoxical reactions (e.g., excitement, aggression, hallucinations)
- Respiratory depression (slow, 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). It can cause fetal harm, including congenital malformations (e.g., cleft lip/palate) if used during the first trimester, and neonatal flaccidity ('floppy infant syndrome'), respiratory depression, and withdrawal symptoms if used during late pregnancy.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations (e.g., cleft lip/palate).
Second Trimester:
Limited data, but continued risk of exposure.
Third Trimester:
Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., irritability, hypertonia, tremors, seizures) in the newborn.
Lactation
Temazepam is excreted into breast milk. Use is generally not recommended during breastfeeding due to potential for sedation, poor feeding, and weight loss in the infant. If use is necessary, monitor the infant closely for adverse effects.
Infant Risk:
Sedation, lethargy, poor feeding, weight loss, respiratory depression. Risk is higher in preterm or jaundiced infants.
Pediatric Use
Safety and efficacy have not been established in pediatric patients (under 18 years of age). Use is not recommended.
Geriatric Use
Elderly patients are more sensitive to the effects of benzodiazepines and may experience increased risk of falls, cognitive impairment, and excessive sedation. A lower initial dose (7.5 mg) is recommended, and close monitoring for adverse effects is crucial. Avoid higher doses.
Clinical Information
Clinical Pearls
- Temazepam is an intermediate-acting benzodiazepine, making it suitable for sleep onset and maintenance without excessive daytime sedation for most patients.
- Unlike many other benzodiazepines, temazepam is primarily metabolized by glucuronidation, which means it has fewer significant interactions with CYP450 enzyme inhibitors/inducers.
- Due to the risk of dependence and withdrawal, temazepam should be used for short-term treatment of insomnia (generally 7-10 days, up to 3-4 weeks).
- Patients should be advised about the potential for anterograde amnesia (not remembering events that occur after taking the medication).
- Rebound insomnia (worsening of sleep problems after stopping the medication) can occur upon discontinuation, especially if stopped abruptly. Gradual tapering is essential.
Alternative Therapies
- Zolpidem (Ambien)
- Eszopiclone (Lunesta)
- Zaleplon (Sonata)
- Suvorexant (Belsomra)
- Lemborexant (Dayvigo)
- Ramelteon (Rozerem)
- Doxepin (Silenor)
- Trazodone
- Cognitive Behavioral Therapy for Insomnia (CBT-I) - often considered first-line non-pharmacological treatment.
Cost & Coverage
Average Cost:
$10 - $50 per 30 capsules (7.5mg)
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, a patient fact sheet that provides crucial information. 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 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, and the time it occurred.