Restoril (Temazepam) is a benzodiazepine drug that causes depression of the limbic and reticular system in the brain.
It is used to cure insomnia temporarily (Difficulty falling asleep).
Temazepam Dose in Adults
Restoril (Temazepam) dose in the treatment of Insomnia:
- Oral: Usual dose:
- 15 to 30 mg given at bedtime
- some patients might respond to 7.5 mg in transient insomnia
Temazepam Dose in Children
Restoril is not recommended for use in children.
Pregnancy Risk Factor X
- In animal reproduction studies, adverse events were observed.
- All benzodiazepines will be assumed to cross the placenta.
- Some benzodiazepines have shown teratogenic effects; however, more research is needed.
- Premature births and low birth weight are more common when mothers use benzodiazepines.
- After exposure late in pregnancy, neonates may experience hypoglycemia and respiratory problems.
- Some benzodiazepines can cause withdrawal symptoms in neonates as soon as days or weeks have passed.
- Contraindicated use during pregnancy
Use of Restoril (Temazepam), while breastfeeding
- Breast milk can contain Temazepam.
- If administered to nursing mothers, the manufacturer suggests caution
Temazepam (Restoril) dose in kidney disease:
- The labelling provided by the manufacturer does not mention dosage modifications.
Restoril (Temazepam) dose in liver disease:
- Patients with liver disease will not be able to receive dosage adjustments from the manufacturer's label.
- Advanced liver disease should avoid encephalopathy due to the potential for encephalopathy.
Less Common Side Effects of Restoril (Temazepam) Include:
-
Central Nervous System:
- Drowsiness
- Dizziness
- Lethargy
- Hangover Effect
- Euphoria
- Anxiety
- Confusion
- Dysarthria
- Fatigue
- Headache
- Vertigo
-
Dermatologic:
- Diaphoresis
- Skin Rash
-
Endocrine & Metabolic:
- Decreased Libido
-
Gastrointestinal:
- Diarrhea
-
Neuromuscular & Skeletal:
- Weakness
-
Ophthalmic:
- Blurred Vision
Contraindication to Restoril (Temazepam) Include:
- Pregnancy
- Hypersensitivity to temazepam, any component of the formulation, and other benzodiazepines
- Myasthenia gravis
- Sleep apnea Syndrome
- Previous paradoxical reactions to ethanol or sedative medication
Warnings and precautions
-
Anterograde amnesia
- Anterograde amnesia has also been associated with benzodiazepines
-
Depression in the CNS:
- Can cause CNS depression
- It can impair mental or physical abilities.
- The drug should be used with caution by patients who operate heavy machinery, drivers, or those who perform tasks that require mental alertness.
-
Hypersensitivity reactions
- Hypersensitivity reactions have been linked to the use of sedative/hypnotic agents for sleep, i.e. anaphylaxis and angioedema
- Patients with angioedema should not be treated.
-
Paradoxical reactions
- Paradoxical effects including hyperactivity or violent conduct have been seen with benzodiazepines.
- Those who are young, elderly, have a history of personality disorders, have had alcohol use disorders, or have mental or personality disorders may be at higher risk.
-
Activities that are sleep-related:
- With benzodiazepines, it has been seen that people can engage in risky sleep-related activities like driving, eating, cooking, and making phone calls while they are asleep.
-
Depression
- Patients with depression should be cautious, especially if there is a possibility of suicidal behavior.
-
Hepatic impairment
- Patients with hepatic impairment should be cautious. This drug is less likely to cause hepatic dysfunction than other benzodiazepines.
-
Renal impairment
- Patients with impaired renal function should be cautious.
-
Respiratory disease
- Patients with COPD, sleep apnea or other respiratory diseases should be cautious.
- Significant respiratory depression can be caused by benzodiazepines.
-
Substance abuse disorder
- Patients with a history or severe alcoholism should be cautious.
- Drug dependency is possible.
- With prolonged use, tolerance and psychological dependence may occur.
Temazepam: Drug Interaction
|
Alcohol (Ethyl) |
Alcohol's CNS depressing effect may be amplified by CNS depressants (Ethyl). |
|
Alizapride |
CNS depressants may have an enhanced CNS depressant impact. |
|
Brexanolone |
Brexanolone's CNS depressing effects may be amplified by other CNS depressants. |
|
Brimonidine (Topical) |
CNS depressants may have an enhanced CNS depressant impact. |
|
Bromopride |
CNS depressants may have an enhanced CNS depressant impact. |
|
Cannabidiol |
CNS depressants may have an enhanced CNS depressant impact. |
|
Cannabis |
CNS depressants may have an enhanced CNS depressant impact. |
|
Chlorphenesin Carbamate |
CNS depressants may have an enhanced CNS depressant impact. |
|
CNS Depressants |
CNS depressants may have an enhanced CNS depressant impact. |
|
Dimethindene (Topical) |
CNS depressants may have an enhanced CNS depressant impact. |
|
Doxylamine |
CNS depressants may have an enhanced CNS depressant impact. Management: The producer of the pregnancy-safe drug Diclegis (doxylamine/pyridoxine) particularly advises against combining it with other CNS depressants. |
|
Dronabinol |
CNS depressants may have an enhanced CNS depressant impact. |
|
Esketamine |
CNS depressants may have an enhanced CNS depressant impact. |
|
Fosphenytoin |
The concentration of fosphenytoin in the serum may rise when using benzodiazepines. Chronic treatment with benzodiazepines may not carry as much harm as brief exposure. |
|
HydrOXYzine |
CNS depressants may have an enhanced CNS depressant impact. |
|
Kava Kava |
CNS depressants may have an enhanced CNS depressant impact. |
|
Lofexidine |
CNS depressants may have an enhanced CNS depressant impact. Management: Separate medication interaction monographs cover the drugs indicated as exceptions to this one in more detail. |
|
Magnesium Sulfate |
CNS depressants may have an enhanced CNS depressant impact. |
|
Melatonin |
Could make benzodiazepines more sedative. |
|
MetyroSINE |
CNS Depressants may enhance the sedative effect of MetyroSINE. |
|
Minocycline |
CNS depressants may have an enhanced CNS depressant impact. |
|
Mirtazapine |
CNS Depressants may enhance the CNS depressant effect of Mirtazapine. |
|
Nabilone |
CNS depressants may have an enhanced CNS depressant impact. |
|
Phenytoin |
Phenytoin serum levels may rise in response to benzodiazepines. There may not be as much risk from short-term use of benzodiazepines as there is from long-term treatment. |
|
Piribedil |
Piribedil's CNS depressing effects may be enhanced by other CNS depressants |
|
Pramipexole |
The sedative effects of pramipexole might be enhanced by CNS depressants. |
|
ROPINIRole |
The sedative effects of CNS depressants may increase those of ROPINIRole. |
|
Rotigotine |
Rotigotine's sedative effects may be boosted by CNS depressants. |
|
Rufinamide |
CNS depressants' harmful or toxic effects could be increased. Particularly, drowsiness and lightheadedness could be worsened. |
|
Selective Serotonin Reuptake Inhibitors |
Selective serotonin reuptake inhibitors may have a worsened or more hazardous effect when taken with CNS depressants. Particularly, there may be an increased risk of psychomotor impairment. |
|
Teduglutide |
Benzodiazepines' serum concentration may rise. |
|
Tetrahydrocannabinol |
CNS depressants may have an enhanced CNS depressant impact. |
|
Tetrahydrocannabinol and Cannabidiol |
CNS depressants may have an enhanced CNS depressant impact. |
|
Trimeprazine |
CNS depressants may have an enhanced CNS depressant impact. |
|
Yohimbine |
May lessen the therapeutic impact of anxiety medications. |
|
Risk Factor D (Consider therapy modification) |
|
|
Blonanserin |
Blonanserin's CNS depressing effects may be enhanced by other CNS depressants. |
|
Buprenorphine |
|
|
Chlormethiazole |
May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. |
|
CloZAPine |
Benzodiazepines may intensify CloZAPine's harmful or hazardous effects. Prior to starting clozapine, consider lowering the dose of benzodiazepines or even stopping them altogether. |
|
Droperidol |
CNS depressants may have an enhanced CNS depressant impact. Consider lowering the dosage of droperidol or other CNS drugs (such as opioids or barbiturates) when they are used concurrently. In separate drug interaction monographs, exceptions to this monograph are covered in more detail. |
|
Flunitrazepam |
CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. |
|
HYDROcodone |
CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Methadone |
The CNS depressive effect of methadone may be strengthened by benzodiazepines. Management: When at all possible, clinicians should refrain from combining the use of benzodiazepines with methadone; nonetheless, any combination should be used with extreme caution. |
|
Methotrimeprazine |
CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. |
|
Opioid Agonists |
CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
OxyCODONE |
CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Perampanel |
May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. |
|
Suvorexant |
CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. |
|
Tapentadol |
May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Theophylline Derivatives |
May diminish the therapeutic effect of Benzodiazepines. |
|
Zolpidem |
CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. |
|
Risk Factor X (Avoid combination) |
|
|
Azelastine (Nasal) |
Azelastine's CNS depressing impact may be amplified by CNS depressants (Nasal). |
|
Bromperidol |
May enhance the CNS depressant effect of CNS Depressants. |
|
OLANZapine |
May enhance the adverse/toxic effect of Benzodiazepines. Management: Avoid concomitant use of parenteral benzodiazepines and IM olanzapine due to risks of additive adverse events (e.g., cardiorespiratory depression). Olanzapine prescribing information provides no specific recommendations regarding oral administration. |
|
Orphenadrine |
CNS Depressants may enhance the CNS depressant effect of Orphenadrine. |
|
Oxomemazine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Paraldehyde |
CNS Depressants may enhance the CNS depressant effect of Paraldehyde. |
|
Sodium Oxybate |
Benzodiazepines may enhance the CNS depressant effect of Sodium Oxybate. |
|
Thalidomide |
The CNS depressing effect of thalidomide may be enhanced by CNS depressants. |
Monitor:
- Respiratory and cardiovascular status.
How to Administer Temazepam?
Restoril should be taken after meals before going to bed.
Mechanism of action of Restoril (Temazepam):
- Restoril is able to bind to stereospecific benzodiazepine receptors at multiple sites in the central nervous system.
- This includes the limbic system and reticular formation on postsynaptic GABA neurons.
- Increased neuronal membrane permeability for chloride ions results in an increase in neuronal excitability, which enhances the inhibitory effects of GABA.
- This shift in the chloride ions leads to hyperpolarization (a state that is less excitable) and stabilization.
- The GABA-A receptors appear to be responsible for the effects and receptors of benzodiazepine.
- Benzodiazepines don't bind to GABAB receptors.
Distribution: V :
- 1.4 L/kg
Protein binding:
- 96%
Metabolism:
- Mainy Hepatic; undergoes phase II metabolism
Half-life elimination:
- 3.5-18.4 hours
Time to peak, serum:
- 1.2-1.6 hours
Excretion:
- Via Urine (80% to 90% as inactive metabolites
International Brands of Temazepam:
- DOM-Temazepam
- PHL-Temazepam
- PMS-Temazepam
- Restoril
- Temazepam-15
- Temazepam-30
- TEVA-Temazepam
- Euhypnos
- Euipnos
- Insomniger
- Levanxol
- Mabertin
- Normison
- Nortem
- Planum
- Restoril
- Signopam
- Signopharm
- Temador
- Temaze
- Temazepam ”NM”
- Temazin
- Temtabs
- Tenox
Temazepam Brands in Pakistan:
Restoril (Temazepam) is not available in Pakistan
