Restoril 30mg Capsules

Manufacturer MALLINCKRODT Active Ingredient Temazepam(te MAZ e pam) Pronunciation te MAZ e pam
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.
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Drug Class
Sedative-Hypnotic
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Pharmacologic Class
Benzodiazepine
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Pregnancy Category
Category D
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FDA Approved
May 1981
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Temazepam is a medication used to treat 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. It's usually taken for a short period, as directed by your doctor.
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How to Use This Medicine

Taking Your Medication

To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines. You can take this medication with or without food. It's essential to take it immediately before bedtime. Ensure you have a full night's sleep (at least 7 to 8 hours) before you need to be active again. If you continue to experience difficulty sleeping after 7 to 10 days, consult your doctor.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry location, avoiding bathrooms. Keep it in a secure place where children cannot access it, and it's out of reach of others. Consider using a locked box or area to safeguard the medication. Keep all medications away from pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best disposal method, consult your pharmacist. You may also want to explore drug take-back programs in your area.

Missing a Dose

If you take this medication regularly, take a missed dose as soon as you remember. However, if you won't be able to get at least 7 hours of sleep after taking the missed dose, skip it and resume your normal schedule. Avoid taking two doses at the same time or extra doses. If you take this medication as needed, do not take it more frequently than prescribed by your doctor.
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Lifestyle & Tips

  • Take exactly as prescribed, usually just before bedtime, and only when you have at least 7-8 hours available for sleep.
  • Do not take more than the prescribed dose or more often than prescribed.
  • Avoid alcohol and other sedating medications (e.g., opioids, cold/allergy medicines) while taking temazepam, as this can cause dangerous drowsiness and breathing problems.
  • Do not drive or operate heavy machinery after taking temazepam, or until you know how it affects you.
  • Do not stop taking this medication suddenly, especially if you have been taking it regularly for a while. Your doctor will guide you on how to slowly reduce the dose to avoid withdrawal symptoms.
  • Report any unusual thoughts or behaviors (e.g., aggression, hallucinations, suicidal thoughts) to your doctor immediately.
  • Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed).

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mg orally once daily at bedtime
Dose Range: 7.5 - 30 mg

Condition-Specific Dosing:

insomnia: 15 mg to 30 mg orally once daily at bedtime, 30 minutes before desired sleep. Use the lowest effective dose for the shortest duration possible.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for increased sedation.
Moderate: No specific adjustment recommended, but monitor for increased sedation.
Severe: Consider lower initial dose (e.g., 7.5 mg) and monitor closely for increased sedation and adverse effects due to potential accumulation of metabolites.
Dialysis: Temazepam is not significantly removed by dialysis. Monitor for increased sedation.

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor for increased sedation.
Moderate: Consider lower initial dose (e.g., 7.5 mg) and monitor closely for increased sedation and adverse effects.
Severe: Contraindicated or use with extreme caution at significantly reduced doses (e.g., 7.5 mg) due to impaired metabolism and increased risk of encephalopathy and prolonged sedation.
Confidence: Medium

Pharmacology

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Mechanism of Action

Temazepam is a benzodiazepine that 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. This results in sedative, hypnotic, anxiolytic, anticonvulsant, and muscle relaxant properties.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: 2-3 hours
FoodEffect: Food may delay Tmax and slightly decrease Cmax, but overall absorption is not significantly affected.

Distribution:

Vd: Approximately 1.3-1.5 L/kg
ProteinBinding: Approximately 96%
CnssPenetration: Yes

Elimination:

HalfLife: 8-20 hours (mean 10-13 hours)
Clearance: Not readily available, but primarily via metabolism and renal excretion.
ExcretionRoute: Renal (approximately 80-90% as glucuronide conjugates)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 20-40 minutes
PeakEffect: 2-3 hours (peak plasma concentration correlates with peak hypnotic effect)
DurationOfAction: 6-8 hours (hypnotic effect)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND PHYSICAL DEPENDENCE AND WITHDRAWAL REACTIONS

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. After initiating temazepam, monitor patients regularly for the development of these behaviors or conditions.

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.
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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
Performing tasks or actions while not fully awake, such as driving, eating, or having sex, without remembering them later

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Headache
Dizziness
Feeling sleepy or groggy the next day
Fatigue or weakness
Upset stomach
Feeling nervous or excitable

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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.
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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 mood or behavior (e.g., agitation, aggression, hallucinations)
  • Sleep-walking or performing other activities while not fully awake (e.g., driving, eating, making phone calls) and having no memory of it
  • Symptoms of withdrawal if stopped suddenly (e.g., rebound insomnia, anxiety, tremors, sweating, muscle cramps, seizures)
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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 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 the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

To ensure your safety, it is vital to verify that it is acceptable 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.
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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, 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 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, contact 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 newborns. Discuss this with your doctor to understand the potential risks.

If you are breastfeeding or plan to breastfeed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Confusion
  • Slurred speech
  • Slowed reflexes
  • Ataxia (loss of coordination)
  • Hypotension (low blood pressure)
  • Bradypnea (slowed breathing)
  • Coma

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Overdose can be fatal, especially when combined with alcohol or other CNS depressants.

Drug Interactions

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Major Interactions

  • Opioid analgesics (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.
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Moderate Interactions

  • Antifungals (e.g., fluconazole, ketoconazole): May slightly increase temazepam levels, though less significant than for CYP-metabolized benzodiazepines.
  • Cimetidine: May slightly inhibit temazepam metabolism, leading to increased levels.
  • Probenecid: May inhibit glucuronidation, potentially increasing temazepam levels.
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Minor Interactions

  • Rifampin: May induce glucuronidation, potentially decreasing temazepam levels (less common interaction).

Monitoring

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Baseline Monitoring

Sleep history and assessment of insomnia etiology

Rationale: To determine appropriateness of therapy and identify underlying causes of insomnia.

Timing: Prior to initiation of therapy

Mental status and cognitive function

Rationale: To establish baseline and monitor for cognitive impairment or paradoxical reactions.

Timing: Prior to initiation of therapy

Respiratory function (especially in patients with respiratory compromise)

Rationale: To assess risk of respiratory depression, particularly with concomitant opioid use.

Timing: Prior to initiation of therapy

History of substance abuse or dependence

Rationale: To assess risk of abuse, misuse, and addiction.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy of sleep improvement

Frequency: Regularly during treatment, especially during initial weeks and upon dose changes.

Target: Improved sleep onset, duration, and quality.

Action Threshold: Lack of improvement or worsening of insomnia may indicate need for re-evaluation or alternative therapy.

Signs of CNS depression (e.g., excessive sedation, dizziness, ataxia, cognitive impairment)

Frequency: Daily, especially during initial treatment and dose adjustments.

Target: Absence of excessive sedation or impairment.

Action Threshold: Presence of significant CNS depression warrants dose reduction or discontinuation.

Signs of paradoxical reactions (e.g., excitement, aggression, hallucinations)

Frequency: Daily, especially during initial treatment.

Target: Absence of paradoxical reactions.

Action Threshold: Occurrence of paradoxical reactions requires immediate discontinuation.

Signs of abuse, misuse, or dependence

Frequency: Regularly throughout therapy, especially with long-term use.

Target: Absence of drug-seeking behavior, escalating doses, or withdrawal symptoms.

Action Threshold: Evidence of abuse/dependence requires re-evaluation of therapy and potential referral for specialized treatment.

Respiratory rate and depth (especially with concomitant opioid use)

Frequency: As clinically indicated, particularly if co-prescribed with opioids.

Target: Normal respiratory rate and depth.

Action Threshold: Bradypnea or shallow breathing warrants immediate medical attention.

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Symptom Monitoring

  • Excessive daytime drowsiness
  • Dizziness
  • Lightheadedness
  • Ataxia (impaired coordination)
  • Confusion
  • Memory impairment (anterograde amnesia)
  • Slurred speech
  • Paradoxical excitement or agitation
  • Hallucinations
  • Aggression
  • Depressed mood or suicidal ideation (rare, but monitor)
  • Withdrawal symptoms upon abrupt discontinuation (e.g., rebound insomnia, anxiety, tremors, seizures)

Special Patient Groups

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Pregnancy

Temazepam is classified as Pregnancy Category D. It should not be used during pregnancy due to evidence of fetal risk. Benefits may outweigh risks in life-threatening situations or for severe disease where safer drugs cannot be used.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate) has been suggested in some studies, though data are conflicting.
Second Trimester: Not well-studied, but continued exposure carries risks.
Third Trimester: Risk of 'floppy infant syndrome' (hypotonia, lethargy, feeding difficulties, hypothermia, respiratory depression) if used late in pregnancy. Risk of neonatal withdrawal symptoms (e.g., irritability, hypertonia, tremors, feeding problems, seizures) if used chronically during pregnancy.
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Lactation

Temazepam is excreted into breast milk. Use is generally discouraged due to potential for infant sedation and withdrawal symptoms upon discontinuation of breastfeeding. If use is necessary, monitor the infant closely for adverse effects.

Infant Risk: L3 (Moderately Safe) - Potential for infant sedation, poor feeding, and withdrawal symptoms. Monitor infant for drowsiness, poor feeding, and developmental milestones. Consider alternative agents or pump and dump if possible.
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Pediatric Use

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is generally not recommended.

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Geriatric Use

Elderly patients are more sensitive to the effects of benzodiazepines and may experience increased risk of CNS adverse effects (e.g., excessive sedation, dizziness, ataxia, falls, cognitive impairment). A lower initial dose (e.g., 7.5 mg) is recommended, and patients should be closely monitored.

Clinical Information

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Clinical Pearls

  • Temazepam is a short-to-intermediate acting benzodiazepine, making it suitable for sleep onset and maintenance without excessive daytime sedation for most patients.
  • Due to its direct glucuronidation, temazepam has fewer significant drug-drug interactions related to CYP450 enzymes compared to other benzodiazepines (e.g., alprazolam, diazepam).
  • Always assess for underlying causes of insomnia before initiating temazepam; it is intended for short-term management (typically 7-10 days).
  • Educate patients thoroughly about the risks of dependence, withdrawal, and the dangers of concomitant use with alcohol or opioids.
  • Gradual tapering is crucial when discontinuing temazepam, especially after prolonged use, to minimize withdrawal symptoms.
  • Paradoxical reactions (e.g., excitement, aggression) can occur, particularly in pediatric or geriatric patients, or those with psychiatric disorders. Discontinue immediately if these occur.
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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, Mirtazapine, Doxepin (Silenor)
  • Antihistamines: Diphenhydramine, Doxylamine (OTC)
  • Non-pharmacological therapies: Cognitive Behavioral Therapy for Insomnia (CBT-I), sleep hygiene education, relaxation techniques, stimulus control therapy.
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules (generic 30mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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, a patient fact sheet that provides crucial information. It is vital 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 guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.