Restoril 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
Hypnotic
Pharmacologic Class
Benzodiazepine; GABA-A Receptor Agonist
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, 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 sleep longer. It's usually taken for a short period, as directed by your doctor.
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 the 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 the 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 area to secure the 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. Instead, consult with your pharmacist for the best disposal method, and explore potential 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 the 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 the 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 area to secure the 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. Instead, consult with your pharmacist for the best disposal method, and explore potential 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 can get a full 7-8 hours of sleep.
- Do not take more than the prescribed dose.
- Avoid alcohol and other central nervous system depressants (e.g., pain medications, cold/allergy medicines) while taking temazepam, as this can lead to dangerous sedation and breathing problems.
- Do not drive or operate heavy machinery after taking temazepam until you know how it affects you, as it can cause drowsiness and impaired coordination.
- Do not stop taking this medication suddenly, especially if you have been taking it for a while, as this can lead to withdrawal symptoms. Your doctor will help you taper off slowly.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products.
- This medication is for short-term use; discuss long-term sleep strategies with your doctor.
Available Forms & Alternatives
Available Strengths:
Generic 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:
elderly_or_debilitated:
Initial dose of 7.5 mg orally once daily at bedtime
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but use with caution.
Moderate:
No specific dose adjustment generally required, but use with caution.
Severe:
Use with caution; consider lower initial doses (e.g., 7.5 mg) and monitor for increased sedation.
Dialysis:
Temazepam is not significantly removed by dialysis. Use with caution and monitor for increased sedation.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required, but use with caution.
Moderate:
Consider lower initial doses (e.g., 7.5 mg) and titrate carefully based on response and tolerability.
Severe:
Contraindicated or use with extreme caution; significant dose reduction (e.g., 7.5 mg) and close monitoring are necessary due to impaired metabolism and increased risk of adverse effects, including hepatic encephalopathy.
Pharmacology
Mechanism of Action
Temazepam is a benzodiazepine that binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron at various sites within the central nervous system, including the limbic system, reticular formation, and cerebral cortex. It potentiates the inhibitory effects of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by increasing the frequency of chloride channel opening, leading to hyperpolarization of the neuron and decreased neuronal excitability.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
2-3 hours
FoodEffect:
Food may delay absorption and 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 10-17 hours)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 80-90% as glucuronide conjugates)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
20-40 minutes
PeakEffect:
2-3 hours
DurationOfAction:
6-8 hours (intermediate-acting)
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. Follow patients for signs and symptoms of respiratory depression and sedation. The risks of abuse, misuse, and addiction with benzodiazepines are serious and can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
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 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, 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 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, 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:
- Excessive drowsiness or sedation during the day
- Dizziness or lightheadedness
- Confusion or memory problems
- Difficulty breathing or shallow breathing
- Unusual changes in behavior or mood (e.g., agitation, aggression, hallucinations, worsening depression)
- Sleepwalking or performing other activities while not fully awake (e.g., driving, making food, talking on the phone) and having no memory of it
- 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. Be sure to describe the allergic reaction you experienced, including any 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 between this medication and other drugs or health conditions.
To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to determine whether it is safe for you 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.
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.
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 drugs or health conditions.
To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to determine whether it is safe for you 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.
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, a phenomenon known as 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 other 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, rise slowly from a sitting or lying position. Be cautious when navigating stairs.
It is crucial to avoid consuming alcohol 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 may impair your actions, 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, a phenomenon known as 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 other 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, rise slowly from a sitting or lying position. Be cautious when navigating stairs.
It is crucial to avoid consuming alcohol 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 may impair your actions, 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:
- Extreme drowsiness
- Confusion
- Slurred speech
- Slowed reflexes
- Lack of coordination (ataxia)
- Hypotension (low blood pressure)
- Respiratory depression (slow, shallow breathing)
- Coma
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. In the U.S., you can also contact a poison control center at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Strong opioids (e.g., fentanyl, oxycodone, hydrocodone) due to risk of profound sedation, respiratory depression, coma, and death.
Major Interactions
- Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics, skeletal muscle relaxants) - increased risk of additive CNS depression.
- Sodium oxybate (Xyrem) - profound CNS depression.
- Cimetidine, disulfiram, fluoxetine, fluvoxamine, omeprazole (CYP inhibitors, though temazepam is primarily glucuronidated, some minor interactions may occur with other benzodiazepines, caution advised).
Moderate Interactions
- Digoxin - may increase digoxin levels (monitor digoxin levels).
- Probenecid - may inhibit temazepam glucuronidation, potentially increasing temazepam levels.
- Rifampin - may induce temazepam metabolism, potentially decreasing temazepam levels.
- Oral contraceptives - may alter temazepam metabolism (variable effects).
Minor Interactions
- Theophylline - may antagonize sedative effects of benzodiazepines.
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 examination
Rationale: To identify any underlying psychiatric conditions (e.g., depression, anxiety) that may contribute to insomnia and require specific treatment.
Timing: Prior to initiation of therapy
Renal and hepatic function tests
Rationale: To assess baseline organ function, especially in elderly or patients with pre-existing conditions, as dose adjustments may be needed.
Timing: Prior to initiation of therapy, if clinically indicated
Routine Monitoring
Efficacy (sleep onset, duration, quality)
Frequency: Regularly during therapy, especially during initial weeks and dose adjustments
Target: Improved sleep parameters, reduced nocturnal awakenings
Action Threshold: Lack of improvement, worsening insomnia, or development of tolerance may indicate need for re-evaluation or alternative therapy.
Adverse effects (e.g., daytime drowsiness, dizziness, cognitive impairment, ataxia)
Frequency: Regularly, especially during initial weeks and dose adjustments
Target: Minimal to no adverse effects
Action Threshold: Significant or persistent adverse effects may require dose reduction or discontinuation.
Signs of dependence, abuse, or withdrawal
Frequency: Periodically throughout therapy, especially with long-term use
Target: Absence of drug-seeking behavior, escalating doses, or withdrawal symptoms upon dose reduction/discontinuation.
Action Threshold: Evidence of dependence or abuse requires re-evaluation of treatment plan and potential referral for specialized care. Withdrawal symptoms necessitate slow tapering.
Respiratory status (especially with concomitant opioid use or respiratory compromise)
Frequency: As clinically indicated, particularly during initiation or dose escalation with opioids
Target: Normal respiratory rate and effort
Action Threshold: Bradypnea, hypoventilation, or respiratory distress requires immediate medical attention.
Symptom Monitoring
- Excessive sedation
- Dizziness
- Confusion
- Ataxia (impaired coordination)
- Memory impairment (anterograde amnesia)
- Paradoxical reactions (e.g., excitement, aggression, hallucinations, worsening insomnia)
- Respiratory depression (especially with other CNS depressants)
- Signs of withdrawal (e.g., anxiety, tremors, rebound insomnia, seizures) upon abrupt discontinuation
Special Patient Groups
Pregnancy
Temazepam is contraindicated in pregnancy (Pregnancy Category X) due to evidence of fetal risk. Benzodiazepines can cause congenital malformations, particularly during the first trimester, and neonatal flaccidity, respiratory depression, and withdrawal symptoms if used late in pregnancy.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations (e.g., cleft lip/palate) based on some studies, though data are conflicting.
Second Trimester:
Potential for fetal CNS depression.
Third Trimester:
Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., irritability, tremors, hypertonia) in the neonate if used near term.
Lactation
Temazepam is excreted into breast milk. Due to the potential for sedation, feeding difficulties, and withdrawal symptoms in the infant, use is generally not recommended during breastfeeding. If use is unavoidable, monitor the infant closely for adverse effects.
Infant Risk:
L3 (Moderate concern). Potential for sedation, lethargy, poor feeding, and weight gain in the infant. Withdrawal symptoms may occur if the mother discontinues the drug abruptly.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in children under 18 years of age.
Geriatric Use
Elderly patients are more sensitive to the effects of benzodiazepines and are at increased risk for adverse effects such as excessive sedation, dizziness, falls, and cognitive impairment. Lower initial doses (e.g., 7.5 mg) are recommended, and patients should be closely monitored.
Clinical Information
Clinical Pearls
- Temazepam is an intermediate-acting benzodiazepine, making it suitable for patients who have difficulty falling asleep and/or staying asleep.
- Due to its potential for dependence and withdrawal, temazepam should be used for short-term treatment of insomnia (generally 7-10 days, not more than 2-4 weeks).
- Patients should be advised to take temazepam immediately before going to bed, only when they can commit to a full night's sleep (7-8 hours), to minimize residual daytime sedation.
- Rebound insomnia, characterized by a temporary worsening of sleep problems, may occur upon discontinuation, especially after prolonged use. Tapering the dose gradually can help mitigate this.
- Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, particularly in elderly or pediatric patients, or those with psychiatric disorders. Discontinue if these occur.
- Assess for underlying causes of insomnia (e.g., depression, anxiety, sleep apnea) before initiating benzodiazepine therapy, as these may require specific treatment.
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), daridorexant (Quviviq)
- Antidepressants with sedative properties: trazodone, doxepin (Silenor)
- Antihistamines: diphenhydramine, doxylamine
- Non-pharmacological treatments: Cognitive Behavioral Therapy for Insomnia (CBT-I), sleep hygiene practices, relaxation techniques.
Cost & Coverage
Average Cost:
$10 - $30 per 30 capsules (7.5mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, contact your doctor immediately. It's essential to keep your medication to yourself and not take anyone else's prescription. This medication includes a Medication Guide, which provides important information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, call the poison control center or seek immediate medical attention. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.