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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Temazepam
Generic Name
Temazepam
Active Ingredient
TemazepamCategory
Benzodiazepine [EPC]
Variants
83
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 7.5 mg/1 | CAPSULE | ORAL | 63629-8601 |
| 15 mg/1 | CAPSULE | ORAL | 70518-2487 |
| 22.5 mg/1 | CAPSULE | ORAL | 0406-9959 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Temazepam, you must consult a qualified healthcare professional.
| 30 mg/1 | CAPSULE | ORAL | 71335-2910 |
| 15 mg/1 | CAPSULE | ORAL | 71335-9741 |
| 15 mg/1 | CAPSULE | ORAL | 43353-312 |
| 30 mg/1 | CAPSULE | ORAL | 71610-626 |
| 30 mg/1 | CAPSULE | ORAL | 72162-1825 |
| 22.5 mg/1 | CAPSULE | ORAL | 72162-1827 |
| 30 mg/1 | CAPSULE | ORAL | 43547-614 |
| 30 mg/1 | CAPSULE | ORAL | 63629-1621 |
| 15 mg/1 | CAPSULE | ORAL | 65162-556 |
+ 38 more variants
Detailed information about Temazepam
Temazepam is a benzodiazepine medication primarily indicated for the short-term treatment of insomnia. It works by enhancing the effects of gamma-aminobutyric acid (GABA) in the brain to produce a calming effect and facilitate sleep.
The dosage of Temazepam must be individualized based on the patient's age, medical condition, and response to treatment. According to clinical guidelines, the lowest effective dose should always be used to minimize the risk of side effects and dependence.
Temazepam is NOT approved for use in pediatric patients (children and adolescents under 18 years of age). The safety and effectiveness of this medication have not been established in this population. Benzodiazepines can have unpredictable effects on the developing brain and may cause paradoxical excitation (increased agitation) in children.
While Temazepam is primarily excreted as inactive metabolites in the urine, patients with severe renal (kidney) impairment should be monitored closely. Significant accumulation of the parent drug is unlikely, but the altered physiological state may increase sensitivity to CNS depressants.
Because the liver is the primary site of glucuronidation, patients with hepatic (liver) impairment may experience delayed clearance of the drug. Healthcare providers typically start with the lowest possible dose (7.5 mg) and monitor for signs of excessive sedation.
In the elderly or debilitated patient, the recommended starting dose is 7.5 mg. Older adults are more sensitive to the effects of benzodiazepines and are at a significantly higher risk for ataxia (lack of muscle coordination), confusion, and falls. Higher doses (15 mg or 30 mg) should be used with extreme caution in this population.
If you miss a dose of Temazepam, take it only if you still have time for a full 7 to 8 hours of sleep. If you wake up in the middle of the night and realize you missed your dose, but you only have a few hours left before your alarm goes off, skip the missed dose. Taking it too late in the night increases the risk of daytime impairment and accidents. Never 'double up' on doses to make up for a missed one.
An overdose of Temazepam can be life-threatening, especially if combined with alcohol or other CNS depressants (like opioids).
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as sudden discontinuation can lead to withdrawal symptoms.
Common side effects of Temazepam are typically related to its primary action as a central nervous system depressant. These effects are most pronounced during the first few days of treatment and may diminish as the body adjusts to the medication.
Temazepam is a powerful sedative that affects the brain's ability to process information and coordinate physical movements. Patients must be fully aware that their mental alertness and physical coordination may be impaired the day after taking Temazepam. This 'residual effect' can occur even if the patient feels fully awake.
1. Risks from Concomitant Use with Opioids: 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.
2. Abuse, Misuse, and Addiction: The use of benzodiazepines, including Temazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other substances, such as alcohol, which is associated with a higher frequency of serious adverse outcomes. Before prescribing Temazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
Temazepam must NEVER be used in the following circumstances:
Temazepam is considered highly risky during pregnancy. According to the FDA, benzodiazepines can cause fetal harm when administered to pregnant women. Exposure during the first trimester has been linked to an increased risk of congenital malformations, specifically oral clefts (cleft lip/palate). If used during the third trimester or during labor, the infant may suffer from 'Floppy Infant Syndrome,' characterized by hypotonia (low muscle tone), lethargy, and sucking difficulties. Additionally, infants born to mothers who took benzodiazepines chronically late in pregnancy may develop physical dependence and exhibit withdrawal symptoms (hyperexcitability, crying, tremors) in the postnatal period.
Temazepam is excreted in human breast milk. Because the neonatal liver is immature and cannot process benzodiazepines efficiently, the drug can accumulate in the nursing infant. This can cause excessive sedation, poor feeding, and weight loss in the baby. Generally, breastfeeding is not recommended while taking Temazepam. If the medication is essential for the mother, the infant must be closely monitored for signs of CNS depression.
Temazepam is not approved for use in children. The safety and efficacy of the drug in patients under 18 years of age have not been established. There are concerns regarding the impact of sedative-hypnotics on brain development and the increased risk of paradoxical reactions (such as extreme hyperactivity or aggression) in pediatric patients.
Temazepam is a benzodiazepine that exerts its effects by binding to the benzodiazepine site on the GABA-A receptor complex in the central nervous system. This receptor is a ligand-gated chloride ion channel. When Temazepam binds, it increases the frequency of the channel opening in response to the inhibitory neurotransmitter GABA. This leads to an influx of chloride ions, hyperpolarization of the postsynaptic neuron, and a resulting decrease in neuronal firing. This 'braking' action on the brain produces sedation, hypnosis, skeletal muscle relaxation, and anticonvulsant activity.
The pharmacodynamic effects of Temazepam are dose-dependent. At low doses, it provides mild sedation. At the standard doses for insomnia (15-30 mg), it significantly shortens the time to sleep onset and increases total sleep time. Unlike some older barbiturates, Temazepam does not significantly suppress REM (Rapid Eye Movement) sleep at standard doses, although it does alter sleep architecture by increasing Stage 2 sleep and decreasing Stages 3 and 4 (deep sleep).
| Parameter | Value |
Common questions about Temazepam
Temazepam is a prescription medication primarily used for the short-term treatment of insomnia. It is specifically helpful for patients who have trouble falling asleep or those who wake up frequently during the night. Healthcare providers typically prescribe it for a duration of 7 to 10 days to help reset a patient's sleep cycle. It belongs to the benzodiazepine class, which works by calming the central nervous system. Because it can be habit-forming, it is not intended for long-term use. Always consult your doctor to see if your insomnia might be caused by an underlying condition before starting this medication.
The most frequently reported side effects of Temazepam include daytime drowsiness, dizziness, and a 'hangover' feeling the next morning. Some patients also experience lethargy, lightheadedness, and a slight lack of coordination. These effects are usually most noticeable when first starting the medication or when the dose is increased. Because it stays in your system for several hours, you may feel less alert the following day, which can affect your ability to drive. If these symptoms persist or become bothersome, you should contact your healthcare provider. It is important to ensure you have a full 8 hours to sleep to minimize these side effects.
No, you should strictly avoid alcohol while taking Temazepam. Both alcohol and Temazepam are central nervous system depressants, and combining them can lead to dangerous levels of sedation. This combination significantly increases the risk of life-threatening respiratory depression, where your breathing becomes too slow or shallow to support life. Additionally, mixing the two can lead to extreme confusion, loss of consciousness, and an increased risk of accidental injury or falls. Even small amounts of alcohol can interact poorly with this medication. Always wait until the drug is completely out of your system before consuming alcohol.
Temazepam is generally not considered safe during pregnancy and is traditionally classified in Pregnancy Category X. Clinical data suggests that taking benzodiazepines during the first trimester can increase the risk of birth defects like cleft lip or palate. If taken later in pregnancy, it can cause the baby to be born with 'floppy infant syndrome,' leading to breathing and feeding problems. Furthermore, the newborn may experience withdrawal symptoms after birth if the mother used the drug chronically. If you are pregnant or planning to become pregnant, discuss alternative sleep aids with your doctor. Effective contraception is usually recommended for women of childbearing age taking this medication.
Temazepam is relatively fast-acting, typically reaching its peak concentration in the blood within 1 to 2 hours. Most patients begin to feel significantly drowsy within 30 minutes of taking the capsule. For this reason, it is recommended that you take the medication only when you are ready to go to bed and have a full night ahead of you. Taking it with a high-fat meal can delay the onset of action, meaning it might take longer for you to fall asleep. If you do not feel sleepy within an hour, do not take a second dose. Instead, consult your doctor about the timing and dosage of your treatment.
You should never stop taking Temazepam suddenly if you have been using it for more than a few days. Stopping 'cold turkey' can trigger severe withdrawal symptoms because your brain has become accustomed to the drug's presence. Withdrawal signs can include tremors, sweating, muscle cramps, vomiting, and in severe cases, life-threatening seizures. It can also cause 'rebound insomnia,' where your sleep problems return even worse than before. Your healthcare provider will give you a tapering schedule to slowly lower your dose over time. This gradual reduction helps your brain chemistry adjust safely and minimizes discomfort.
If you miss a dose of Temazepam, you should only take it if you still have time for a full 7 to 8 hours of sleep. If you wake up in the middle of the night and realize you forgot your dose, but you have to be awake in 3 or 4 hours, skip the dose entirely. Taking the medication too late in the night will lead to significant grogginess and impairment the next morning, which can be dangerous for driving. Never take two doses at once to make up for a missed one. Simply wait until the next night to take your regularly scheduled dose. Consistency is key, but safety regarding next-day alertness is the priority.
Weight gain is not a commonly reported side effect of Temazepam in clinical trials. Unlike some antidepressants or antipsychotics that are known to change metabolism or increase appetite, benzodiazepines typically do not have a direct effect on weight. However, some patients might experience 'sleep-eating,' a complex sleep behavior where they eat while not fully awake. This behavior could indirectly lead to weight gain if it happens frequently. Additionally, the lethargy or daytime drowsiness caused by the drug might lead to decreased physical activity. If you notice significant changes in your weight while taking this medication, discuss them with your healthcare provider.
Temazepam can interact with many other medications, especially those that also cause drowsiness. It is particularly dangerous to take it with opioids, as this combination can lead to fatal respiratory depression. You should also be cautious with other sleep aids, anxiety medications, muscle relaxants, and certain antihistamines. Some herbal supplements like Kava and Valerian root can also increase the sedative effects to an unsafe level. Always provide your doctor and pharmacist with a complete list of all the medications and supplements you are currently taking. They can check for potential interactions and adjust your treatment plan to ensure your safety.
Yes, Temazepam is widely available as a generic medication, which is typically much less expensive than the brand-name version, Restoril. Generic versions are required by the FDA to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. They must also prove 'bioequivalence,' meaning they work in the body in the same way and over the same amount of time. Most insurance plans cover generic Temazepam. When you receive your prescription, the capsules may look different depending on the manufacturer, but the clinical effect should remain the same. Check with your pharmacist if you have questions about the specific generic version you receive.
Other drugs with the same active ingredient (Temazepam)
> Warning: Stop taking Temazepam and call your doctor immediately if you experience any of these serious symptoms:
Temazepam is intended for short-term use. Prolonged use (weeks to months) can lead to:
The FDA has issued several Boxed Warnings for Temazepam, the most serious type of warning. These include:
Report any unusual symptoms to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088.
If Temazepam is used for an extended period (which is generally discouraged), healthcare providers may require:
Do NOT drive a car, operate heavy machinery, or engage in hazardous activities until you know how Temazepam affects you the next day. The drug can cause significant impairment in reaction time and coordination, even if you do not 'feel' sleepy. This risk is significantly higher if you did not get a full 7 to 8 hours of sleep.
Alcohol must be strictly avoided while taking Temazepam. Alcohol is a CNS depressant that acts synergistically with benzodiazepines. This means the combination is much more dangerous than either substance alone, significantly increasing the risk of fatal respiratory depression and accidental injury.
Never stop taking Temazepam 'cold turkey' if you have been taking it for more than a few days. Sudden discontinuation can cause severe withdrawal symptoms, including:
Your doctor will provide a tapering schedule to slowly reduce the dose over several days or weeks.
> Important: Discuss all your medical conditions, especially any history of substance abuse or lung disease, with your healthcare provider before starting Temazepam.
Temazepam generally does not interfere with standard clinical laboratory tests. However, it will result in a positive 'Benzodiazepine' result on a standard urine drug screen. If you are undergoing workplace drug testing, you must provide proof of your prescription to the medical review officer.
For each major interaction, the mechanism is usually pharmacodynamic synergy (two drugs doing the same thing to the brain, leading to an over-effect) or pharmacokinetic interference (one drug changing how the other is processed). The management strategy almost always involves dosage reduction, increased monitoring, or choosing an alternative therapy.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those bought over-the-counter.
These conditions require a careful risk-benefit analysis by a physician:
There is a high degree of cross-sensitivity among benzodiazepines. If you are allergic to one (e.g., Valium), you are likely allergic to Temazepam. Furthermore, patients who experience 'paradoxical reactions' to one benzodiazepine are likely to experience them with others in the class.
> Important: Your healthcare provider will evaluate your complete medical history, including your respiratory health and history of allergies, before prescribing Temazepam.
Elderly patients (65 and older) are at the highest risk for adverse effects from Temazepam. Age-related changes in the brain make older adults more sensitive to the sedative and ataxic effects of the drug.
In patients with renal (kidney) impairment, the inactive glucuronide conjugates of Temazepam may accumulate. While these metabolites are not pharmacologically active, the overall physiological stress on the body may require more cautious dosing. Temazepam is not significantly removed by hemodialysis.
Since the liver is responsible for the conjugation of Temazepam, patients with hepatic impairment (Child-Pugh Class B or C) may have a reduced capacity to clear the drug. This leads to a longer half-life and a higher risk of 'day-after' impairment. Dosage should be limited, and the frequency of administration may need to be reduced.
> Important: Special populations require individualized medical assessment and frequent follow-up with a healthcare professional.
| Bioavailability | ~90% |
| Protein Binding | 96% |
| Half-life | 8-15 hours (Mean: 10h) |
| Tmax | 1.2 - 1.6 hours |
| Metabolism | Hepatic (Glucuronidation) |
| Excretion | Renal (>90% as inactive conjugates) |
Temazepam belongs to the benzodiazepine class of drugs, specifically categorized as a sedative-hypnotic. It is related to other medications such as diazepam (Valium), alprazolam (Xanax), and lorazepam (Ativan), but it is specifically optimized for its hypnotic (sleep-inducing) properties rather than its anxiolytic (anxiety-reducing) properties.