Restoril 15mg 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.
🏷️
Drug Class
Hypnotic
🧬
Pharmacologic Class
Benzodiazepine
🀰
Pregnancy Category
Category X
βœ…
FDA Approved
May 1981
βš–οΈ
DEA Schedule
Schedule IV

Overview

ℹ️

What is this medicine?

Temazepam is a medication used for the short-term treatment of insomnia (trouble sleeping). It belongs to a class of drugs called benzodiazepines. It works by calming your brain activity, helping you fall asleep faster and stay asleep longer. It should only be used for a short period, usually 7 to 10 days, as it can be habit-forming.
πŸ“‹

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and do so right before bedtime. It's essential to take this medication only when you can get a full night's sleep, which is at least 7 to 8 hours, before you need to be active again. If you continue to have trouble sleeping after 7 to 10 days, contact your doctor for further guidance.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding 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 your medication. Keep all medications away from pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. 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 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.
πŸ’‘

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 sedating medications while taking temazepam, as this can increase the risk of serious side effects, including severe drowsiness and breathing problems.
  • Do not drive or operate heavy 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 for more than a few days, as this can cause withdrawal symptoms. Your doctor will tell you how to safely reduce your dose.
  • Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed, regular exercise).

Dosing & Administration

πŸ‘¨β€βš•οΈ

Adult Dosing

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

Condition-Specific Dosing:

insomnia: 15 mg to 30 mg orally at bedtime, as needed for short-term treatment of insomnia. For elderly or debilitated patients, an initial dose of 7.5 mg orally at bedtime is recommended.
πŸ‘Ά

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
βš•οΈ

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: No specific dose adjustment recommended, but use with caution. Monitor for increased sedation.
Dialysis: Temazepam is not significantly removed by dialysis. Use with caution and monitor for increased effects.

Hepatic Impairment:

Mild: Use with caution; consider lower initial dose (e.g., 7.5 mg).
Moderate: Use with caution; consider lower initial dose (e.g., 7.5 mg). Monitor closely for adverse effects.
Severe: Use with extreme caution; significant dose reduction (e.g., 7.5 mg) or avoidance may be necessary due to impaired metabolism and increased sensitivity to CNS depressants.

Pharmacology

πŸ”¬

Mechanism of Action

Temazepam is a benzodiazepine that binds to stereospecific benzodiazepine receptors on the postsynaptic gamma-aminobutyric acid (GABA) A receptor complex in the central nervous system (CNS). This binding enhances the inhibitory effects of GABA, leading to increased chloride ion influx into neurons, hyperpolarization, and decreased neuronal excitability. This results in sedative, hypnotic, anxiolytic, anticonvulsant, and muscle relaxant properties.
πŸ“Š

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: Approximately 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% as glucuronide conjugates, 12% as sulfate conjugates)
Unchanged: <1%
⏱️

Pharmacodynamics

OnsetOfAction: Approximately 20-40 minutes
PeakEffect: 2-3 hours (correlates with Tmax)
DurationOfAction: 6-8 hours (sufficient for a full night's sleep)
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 use of benzodiazepines, including temazepam, exposes patients and other users 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. 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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or sedation
  • Difficulty breathing or shallow breathing
  • Unusual confusion or disorientation
  • Memory problems (not remembering events after taking the pill)
  • Aggressive or agitated behavior (paradoxical reactions)
  • Hallucinations
  • Worsening insomnia or new sleep problems after stopping the medication (rebound insomnia)
  • Symptoms of withdrawal if stopped suddenly (e.g., anxiety, tremors, sweating, muscle cramps, seizures)
πŸ“‹

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.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose of any medication without first consulting your doctor.
⚠️

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When used nightly for more than a few weeks, sleep medications like this one may lose their effectiveness in addressing sleep issues, 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 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. Exercise caution when navigating stairs.

Alcohol consumption should be avoided while taking this medication. Do not take this drug if you have consumed alcohol in the evening or before bedtime.

Before using marijuana, other cannabis products, or prescription and over-the-counter medications that can impair your reactions, consult your doctor.

This medication can cause drowsiness and reduced alertness, increasing the risk of falls. This risk is particularly higher in older adults. If you have concerns, discuss them with your doctor.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.

There is a potential risk of harm to the unborn baby if this medication is taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, notify your doctor immediately.

Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Discuss these risks with your doctor.

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

Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Confusion
  • Slurred speech
  • Slowed reflexes
  • Ataxia (loss of coordination)
  • Hypotension (low blood pressure)
  • Respiratory depression (slow, shallow breathing)
  • Coma

What to Do:

Seek immediate medical attention or call emergency services (e.g., 911 in the US). For poison control, call 1-800-222-1222. Overdose management typically involves supportive care, maintaining a patent airway, and monitoring vital signs. Flumazenil, a benzodiazepine receptor antagonist, may be used in severe cases but carries risks, including precipitation of withdrawal or seizures.

Drug Interactions

πŸ”΄

Major Interactions

  • Opioid analgesics (e.g., fentanyl, oxycodone, hydrocodone, morphine)
  • Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antipsychotics, general anesthetics, skeletal muscle relaxants, antihistamines with sedative properties)
🟑

Moderate Interactions

  • Antifungals (e.g., fluconazole, ketoconazole) - potential for increased temazepam levels, though less significant due to conjugation metabolism
  • Macrolide antibiotics (e.g., erythromycin, clarithromycin) - potential for increased temazepam levels
  • Cimetidine (H2 blocker) - potential for increased temazepam levels
  • Probenecid (uricosuric) - may inhibit glucuronidation, increasing temazepam levels
🟒

Minor Interactions

  • Grapefruit juice (minimal effect due to conjugation metabolism)

Monitoring

πŸ”¬

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 assess for underlying psychiatric conditions, cognitive function, and risk of abuse/dependence.

Timing: Prior to initiation of therapy

Concomitant medications review

Rationale: To identify potential drug-drug interactions, especially with other CNS depressants.

Timing: Prior to initiation of therapy

πŸ“Š

Routine Monitoring

Efficacy (sleep onset, duration, quality)

Frequency: Regularly during treatment (e.g., weekly initially, then monthly)

Target: Improved sleep parameters, reduced nocturnal awakenings

Action Threshold: Lack of improvement after 7-10 days, or worsening insomnia, indicates need for re-evaluation.

Adverse effects (e.g., daytime drowsiness, dizziness, cognitive impairment, ataxia)

Frequency: Regularly during treatment

Target: Absence or minimal, tolerable side effects

Action Threshold: Significant or intolerable side effects warrant dose reduction or discontinuation.

Signs of abuse, misuse, or dependence

Frequency: At each follow-up visit

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

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

Respiratory status (especially with concomitant opioid use or respiratory compromise)

Frequency: As clinically indicated, particularly during initiation or dose changes with opioids.

Target: Normal respiratory rate and effort

Action Threshold: Bradypnea, hypoventilation, or respiratory depression requires immediate medical attention.

πŸ‘οΈ

Symptom Monitoring

  • Daytime drowsiness
  • Dizziness
  • Lightheadedness
  • Ataxia (impaired coordination)
  • Confusion
  • Memory impairment (anterograde amnesia)
  • Paradoxical reactions (e.g., excitement, aggression, hallucinations)
  • Rebound insomnia (upon discontinuation)
  • Withdrawal symptoms (e.g., anxiety, tremors, seizures, abdominal cramps, muscle pain, vomiting, sweating) if discontinued abruptly

Special Patient Groups

🀰

Pregnancy

Temazepam is contraindicated in pregnancy (Pregnancy Category X). Benzodiazepines can cause fetal harm when administered to a pregnant woman. There is an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy. Neonatal flaccidity, respiratory and feeding difficulties, and hypothermia have been reported in infants born to mothers who have received benzodiazepines 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 for all benzodiazepines.
Second Trimester: Potential for fetal CNS depression if used, but less data on specific malformations.
Third Trimester: Risk of neonatal withdrawal syndrome (e.g., hypotonia, lethargy, feeding difficulties, respiratory depression, hypothermia) if used near term. Floppy infant syndrome.
🀱

Lactation

Temazepam is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, feeding difficulties, weight loss), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Generally not recommended.

Infant Risk: L4 (Potentially hazardous) - Risk of sedation, poor feeding, and withdrawal symptoms in the infant. Monitor for drowsiness, poor feeding, and developmental delays.
πŸ‘Ά

Pediatric Use

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

πŸ‘΄

Geriatric Use

Elderly patients may be more sensitive to the effects of benzodiazepines, including temazepam, and may be at increased risk for adverse effects such as excessive sedation, dizziness, ataxia, and falls. An initial dose of 7.5 mg orally at bedtime is recommended for elderly or debilitated patients. Monitor closely for CNS depression and paradoxical reactions.

Clinical Information

πŸ’Ž

Clinical Pearls

  • Temazepam has a relatively intermediate half-life among benzodiazepines, making it suitable for maintaining sleep without excessive daytime sedation for most patients.
  • Due to its metabolism primarily by glucuronidation (Phase II), temazepam is less prone to drug interactions involving CYP450 enzymes compared to other benzodiazepines that undergo oxidative metabolism (Phase I).
  • Short-term use (7-10 days) is recommended to minimize the risk of dependence and withdrawal. Re-evaluate patients if insomnia persists beyond this period.
  • Patients should be advised to take temazepam only when they can commit to a full night's sleep (7-8 hours) to avoid residual sedation or memory impairment.
  • Paradoxical reactions (e.g., excitement, aggression, hallucinations) can occur, especially in pediatric, elderly, or psychiatric patients. Discontinue if these occur.
  • Abrupt discontinuation after prolonged use can lead to severe withdrawal symptoms, including seizures. Always taper the dose gradually.
πŸ”„

Alternative Therapies

  • Other benzodiazepine receptor agonists (BZRAs) for insomnia: zolpidem (Ambien), eszopiclone (Lunesta), zaleplon (Sonata)
  • Melatonin receptor agonists: ramelteon (Rozerem)
  • Orexin receptor antagonists: suvorexant (Belsomra), lemborexant (Dayvigo), daridorexant (Quviviq)
  • Antidepressants with sedative properties (off-label for insomnia): trazodone, mirtazapine, doxepin (Silenor)
  • Antihistamines (OTC): diphenhydramine, doxylamine
  • Non-pharmacological treatments: Cognitive Behavioral Therapy for Insomnia (CBT-I), sleep hygiene education, relaxation techniques, stimulus control therapy.
πŸ’°

Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (15mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
πŸ“š

General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them 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. This information will help healthcare professionals provide you with the most effective treatment.