Restoril 30mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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.
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).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
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 patientβs 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.
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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.
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.
Minor Interactions
- Rifampin: May induce glucuronidation, potentially decreasing temazepam levels (less common interaction).
Monitoring
Baseline Monitoring
Rationale: To determine appropriateness of therapy and identify underlying causes of insomnia.
Timing: Prior to initiation of therapy
Rationale: To establish baseline and monitor for cognitive impairment or paradoxical reactions.
Timing: Prior to initiation of therapy
Rationale: To assess risk of respiratory depression, particularly with concomitant opioid use.
Timing: Prior to initiation of therapy
Rationale: To assess risk of abuse, misuse, and addiction.
Timing: Prior to initiation of therapy
Routine Monitoring
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.
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.
Frequency: Daily, especially during initial treatment.
Target: Absence of paradoxical reactions.
Action Threshold: Occurrence of paradoxical reactions requires immediate discontinuation.
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.
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.
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
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:
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.
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 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
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.
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.
Cost & Coverage
General Drug Facts
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.