Restoril 22.5mg 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 D
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, helping you fall asleep faster and stay asleep longer.
How to Use This Medicine
Taking Your Medication
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. It's best to take it right before bedtime. However, do not take it unless 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.
Storing and Disposing of Your Medication
Store this 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. 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 you will not be able to get at least 7 hours of sleep after taking the missed dose, skip it and return to 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 safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. It's best to take it right before bedtime. However, do not take it unless 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.
Storing and Disposing of Your Medication
Store this 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. 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 you will not be able to get at least 7 hours of sleep after taking the missed dose, skip it and return to 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 right before bedtime, 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 central nervous system depressants (e.g., opioids, certain 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, as it can cause drowsiness and impair your ability to perform these tasks.
- Do not stop taking temazepam suddenly, especially if you have been taking it regularly for a while, as this can cause withdrawal symptoms. Your doctor will help you gradually reduce the dose.
- Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
22.5 mg orally once daily at bedtime for insomnia
Dose Range:
7.5 - 30 mg
Condition-Specific Dosing:
insomnia:
7.5 mg to 30 mg orally once daily at bedtime, typically 15 mg or 30 mg. For Restoril 22.5mg, the dose is 22.5 mg.
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 monitor for increased sedation.
Moderate:
No specific dose adjustment generally required, but monitor for increased sedation.
Severe:
Use with caution; consider lower initial doses (e.g., 7.5 mg) and monitor closely for increased sedation and adverse effects.
Dialysis:
Temazepam is not significantly removed by dialysis. Use with caution and monitor for increased sedation.
Hepatic Impairment:
Mild:
Consider lower initial doses (e.g., 7.5 mg) and monitor closely.
Moderate:
Consider lower initial doses (e.g., 7.5 mg) and monitor closely for increased sedation and adverse effects.
Severe:
Contraindicated or use with extreme caution; consider lower initial doses (e.g., 7.5 mg) and monitor closely for increased sedation and adverse effects, including hepatic encephalopathy.
Pharmacology
Mechanism of Action
Temazepam, a benzodiazepine, 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. This binding enhances the inhibitory effects of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the brain, by increasing the frequency of chloride channel opening, leading to hyperpolarization of the neuronal membrane and reduced neuronal excitability.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
1.5 to 2.5 hours
FoodEffect:
Food may delay absorption and peak concentrations, but does not significantly affect the extent of absorption.
Distribution:
Vd:
1.3-1.5 L/kg
ProteinBinding:
Approximately 96%
CnssPenetration:
Yes
Elimination:
HalfLife:
8 to 20 hours (intermediate-acting)
Clearance:
Not readily available (primarily hepatic metabolism)
ExcretionRoute:
Urine (approximately 80% as glucuronide conjugates), Feces (approximately 10%)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
20 to 40 minutes
PeakEffect:
1.5 to 2.5 hours
DurationOfAction:
6 to 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. 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 physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher doses. To reduce the risk of withdrawal reactions, use a gradual tapering strategy when discontinuing temazepam.
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
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 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
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 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
- Difficulty with coordination or balance (ataxia)
- Memory problems (forgetting events that occurred after taking the medication)
- Unusual changes in behavior or mood (e.g., agitation, aggression, hallucinations, confusion, worsening depression)
- Worsening of insomnia or new sleep problems (e.g., sleepwalking, sleep-driving, making phone calls while asleep)
- Difficulty breathing or shallow breathing (especially if combined with opioids)
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 discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments.
Remember, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments.
Remember, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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. To avoid this, use sleep medications for short periods only. If your sleep problems persist, consult your doctor for further guidance.
After taking this medication, avoid driving and other activities that require alertness, as you may still feel sleepy the day after consumption. Only engage in such tasks when you feel fully awake and alert.
To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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 or older, use this medication with caution, as you may be more susceptible to side effects.
There is a risk of harm to the unborn baby if this medication is taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, notify your doctor immediately. Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, low body temperature, or withdrawal symptoms in the newborn, so it is crucial to discuss this with your doctor.
If you are breastfeeding or plan to breastfeed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
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. To avoid this, use sleep medications for short periods only. If your sleep problems persist, consult your doctor for further guidance.
After taking this medication, avoid driving and other activities that require alertness, as you may still feel sleepy the day after consumption. Only engage in such tasks when you feel fully awake and alert.
To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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 or older, use this medication with caution, as you may be more susceptible to side effects.
There is a risk of harm to the unborn baby if this medication is taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, notify your doctor immediately. Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, low body temperature, or withdrawal symptoms in the newborn, so it is crucial to discuss this with your doctor.
If you are breastfeeding or plan to breastfeed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
Overdose Information
Overdose Symptoms:
- Extreme drowsiness
- Confusion
- Slurred speech
- Slowed reflexes
- Ataxia (loss of coordination)
- Hypotension (low blood pressure)
- Bradycardia (slow heart rate)
- 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. For poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Opioids (e.g., fentanyl, oxycodone, hydrocodone): Increased risk of profound sedation, respiratory depression, coma, and death.
- Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics): Additive CNS depressant effects.
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May slightly increase temazepam levels, though temazepam is primarily glucuronidated.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May slightly decrease temazepam levels.
- Probenecid: May inhibit temazepam glucuronidation, potentially increasing temazepam levels and prolonging its effects.
Minor Interactions
- Grapefruit juice: Minimal interaction due to primary glucuronidation.
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 identify pre-existing cognitive impairment and monitor for adverse CNS effects.
Timing: Prior to initiation of therapy
Respiratory status
Rationale: To assess risk for respiratory depression, especially with concomitant opioid use or pre-existing respiratory conditions.
Timing: Prior to initiation of therapy
History of substance abuse
Rationale: To assess risk for abuse, misuse, and dependence.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (sleep onset, duration, quality)
Frequency: Regularly, especially during initial weeks and with dose adjustments
Target: Improved sleep parameters
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Adverse CNS effects (drowsiness, dizziness, ataxia, cognitive impairment)
Frequency: Daily, especially during initial weeks and with dose adjustments
Target: Minimal to no impairment
Action Threshold: Significant or persistent impairment may require dose reduction or discontinuation.
Signs of tolerance, dependence, or withdrawal symptoms
Frequency: Periodically, especially with long-term use or during dose reduction/discontinuation
Target: Absence of these signs
Action Threshold: Presence indicates need for careful tapering or re-evaluation of therapy.
Paradoxical reactions (agitation, hallucinations, aggression)
Frequency: Daily, especially during initial weeks
Target: Absence of these reactions
Action Threshold: Immediate discontinuation if observed.
Symptom Monitoring
- Excessive daytime sleepiness
- Dizziness
- Lightheadedness
- Ataxia (impaired coordination)
- Confusion
- Memory impairment (anterograde amnesia)
- Slurred speech
- Blurred vision
- Headache
- Nausea
- Vomiting
- Paradoxical reactions (e.g., agitation, anxiety, hallucinations, aggression, nightmares, worsening insomnia)
Special Patient Groups
Pregnancy
Temazepam is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Benzodiazepines can cause fetal harm when administered to pregnant women. Risks include congenital malformations (e.g., cleft lip/palate) if used in the first trimester, and neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., hypertonia, tremor, irritability, crying) if used during the third trimester or near delivery.
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:
Limited data, but generally considered less risky than first or third trimester.
Third Trimester:
Risk of neonatal flaccidity (floppy infant syndrome), respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., hypertonia, tremor, irritability, crying) in the neonate.
Lactation
Temazepam is excreted into breast milk. Due to the potential for sedation, feeding difficulties, and withdrawal symptoms in the breastfed infant, use is generally not recommended or should be done with extreme caution. Monitor the infant for drowsiness, poor feeding, and weight gain.
Infant Risk:
Moderate risk (L3) - potential for sedation, poor feeding, and withdrawal symptoms in the infant. Consider alternative agents or monitor infant closely.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is generally not recommended.
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. Avoid use in elderly patients with a history of falls or significant cognitive impairment.
Clinical Information
Clinical Pearls
- Temazepam is an intermediate-acting benzodiazepine, making it suitable for patients who have difficulty falling asleep and/or staying asleep.
- It has a relatively low risk of accumulation compared to longer-acting benzodiazepines, especially in patients with renal impairment, due to its primary metabolism via glucuronidation.
- Always emphasize the importance of taking temazepam immediately before going to bed, only when a full night's sleep (7-8 hours) is possible, to minimize residual daytime sedation.
- Educate patients about the risks of dependence, abuse, and withdrawal, and the importance of not abruptly discontinuing the medication.
- Counsel patients on the critical interaction with opioids and alcohol, stressing the potential for severe respiratory depression and death.
- Consider non-pharmacological interventions for insomnia (e.g., CBT-I) as first-line or adjunctive therapy.
Alternative Therapies
- Other benzodiazepine receptor agonists (Z-drugs): Zolpidem (Ambien), Eszopiclone (Lunesta), Zaleplon (Sonata)
- Melatonin receptor agonists: Ramelteon (Rozerem)
- Orexin receptor antagonists: Suvorexant (Belsomra), Lemborexant (Dayvigo)
- Antidepressants with sedative properties: Trazodone, Doxepin (Silenor)
- Antihistamines: Diphenhydramine, Doxylamine (OTC)
- Melatonin (OTC supplement)
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
Cost & Coverage
Average Cost:
$10 - $30 per 30 capsules (generic 22.5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.