Restoril (Temazepam) - Complete Drug Information

Restoril (Temazepam) is a benzodiazepine drug that causes depression of the limbic and reticular system in the brain.

It is used for the short-term treatment of insomnia (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 Childrens

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:

There are no dosage adjustments given in the manufacturer’s labeling.

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
- With benzodiazepines, paradoxical reactions such as hyperactive or aggressive behavior have been observed
- Risk can be higher in pediatric patients, geriatrics, patients with a history or personality disorder, as well as patients who have had alcohol use disorders or psychiatric/ personality disorders.
Activities that are sleep-related:
- With benzodiazepines, sleep-related dangerous activities such as driving, cooking, eating, and making calls while you're asleep have all been observed.
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

Risk Factor C (Monitor therapy)
Alcohol (Ethyl)	CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl).
Alizapride	May enhance the CNS depressant effect of CNS Depressants.
Brexanolone	CNS Depressants may enhance the CNS depressant effect of Brexanolone.
Brimonidine (Topical)	May enhance the CNS depressant effect of CNS Depressants.
Bromopride	May enhance the CNS depressant effect of CNS Depressants.
Cannabidiol	May enhance the CNS depressant effect of CNS Depressants.
Cannabis	May enhance the CNS depressant effect of CNS Depressants.
Chlorphenesin Carbamate	May enhance the adverse/toxic effect of CNS Depressants.
CNS Depressants	May enhance the adverse/toxic effect of other CNS Depressants.
Dimethindene (Topical)	May enhance the CNS depressant effect of CNS Depressants.
Doxylamine	May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended.
Dronabinol	May enhance the CNS depressant effect of CNS Depressants.
Esketamine	May enhance the CNS depressant effect of CNS Depressants.
Fosphenytoin	Benzodiazepines may increase the serum concentration of Fosphenytoin. Shortterm exposure to benzodiazepines may not present as much risk as chronic therapy.
HydrOXYzine	May enhance the CNS depressant effect of CNS Depressants.
Kava Kava	May enhance the adverse/toxic effect of CNS Depressants.
Lofexidine	May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs.
Magnesium Sulfate	May enhance the CNS depressant effect of CNS Depressants.
Melatonin	May enhance the sedative effect of Benzodiazepines.
MetyroSINE	CNS Depressants may enhance the sedative effect of MetyroSINE.
Minocycline	May enhance the CNS depressant effect of CNS Depressants.
Mirtazapine	CNS Depressants may enhance the CNS depressant effect of Mirtazapine.
Nabilone	May enhance the CNS depressant effect of CNS Depressants.
Phenytoin	Benzodiazepines may increase the serum concentration of Phenytoin. Short-term exposure to benzodiazepines may not present as much risk as chronic therapy.
Piribedil	CNS Depressants may enhance the CNS depressant effect of Piribedil.
Pramipexole	CNS Depressants may enhance the sedative effect of Pramipexole.
ROPINIRole	CNS Depressants may enhance the sedative effect of ROPINIRole.
Rotigotine	CNS Depressants may enhance the sedative effect of Rotigotine.
Rufinamide	May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced.
Selective Serotonin Reuptake Inhibitors	CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced.
Teduglutide	May increase the serum concentration of Benzodiazepines.
Tetrahydrocannabinol	May enhance the CNS depressant effect of CNS Depressants.
Tetrahydrocannabinol and Cannabidiol	May enhance the CNS depressant effect of CNS Depressants.
Trimeprazine	May enhance the CNS depressant effect of CNS Depressants.
Yohimbine	May diminish the therapeutic effect of Antianxiety Agents.
Risk Factor D (Consider therapy modification)
Blonanserin	CNS Depressants may enhance the CNS depressant effect of Blonanserin.
Buprenorphine	CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants.
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 enhance the adverse/toxic effect of CloZAPine. Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine.
Droperidol	May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs.
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	Benzodiazepines may enhance the CNS depressant effect of Methadone. Management: Clinicians should generally avoid concurrent use of methadone and benzodiazepines when possible; any combined use should be undertaken with extra 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)	CNS Depressants may enhance the CNS depressant effect of Azelastine (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	CNS Depressants may enhance the CNS depressant effect of Thalidomide.

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 :