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Related to Restoril: Benzodiazepines, Ativan


Apo-Temazepam, Co Temazepam, Dom-Temazepam, Gen-Temazepam, Novo-Temazepam, Nu-Temazepam, PHL-Temazepam, PMS-Temazepam, Ratio-Temazepam, Restoril

Pharmacologic class: Benzodiazepine

Therapeutic class: Sedative-hypnotic

Controlled substance schedule IV

Pregnancy risk category X


Depresses CNS at limbic, thalamic, and hypothalamic levels. Enhances effects of gamma-aminobutyric acid, resulting in sedation, hypnosis, skeletal muscle relaxation, and anticonvulsant and anxiolytic activity.


Capsules: 7.5 mg, 15 mg, 22.5 mg, 30 mg

Indications and dosages


Adults: 15 mg P.O. at bedtime p.r.n. Range is 7.5 to 30 mg.

Dosage adjustment

• Elderly or debilitated patients


• Hypersensitivity to drug or other benzodiazepines

• Pregnancy


Use cautiously in:

• chronic pulmonary insufficiency, hepatic dysfunction, renal disease, psychoses, drug abuse

• history of suicide attempt or drug abuse

• elderly or debilitated patients

• breastfeeding patients

• children younger than age 15.


• Give at bedtime with or without food.

Adverse reactions

CNS: hangover, headache, dizziness, drowsiness, lethargy, fatigue, paradoxical stimulation, light-headedness, talkativeness, irritability, nervousness, confusion, euphoria, relaxed feeling, tremor, incoordination, impaired memory, nightmares, paresthesia

CV: chest pain, palpitations, tachycardia

EENT: eye irritation, pain, and swelling; photophobia; tinnitus

GI: nausea, vomiting, constipation, diarrhea, heartburn, abdominal pain, dry mouth, anorexia

Musculoskeletal: joint pain

Other: altered taste, body pain, physical or psychological drug dependence, drug tolerance


Drug-drug. Antidepressants, antihistamines, opioid analgesics, other sedative-hypnotics: additive CNS depression

Digoxin: increased digoxin blood level, greater risk of toxicity

Probenecid: faster temazepam onset and prolonged effects

Theophylline: antagonism of temazepam's sedative effects

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors. Alcohol use: additive CNS depression

Smoking: increased drug metabolism

Patient monitoring

• Monitor neurologic status carefully. Check for paradoxical reactions, especially in elderly patient.

• Watch for signs and symptoms of physical and psychological drug dependence. Stay alert for drug hoarding.

Patient teaching

• Advise patient to establish effective bedtime routine, to minimize insomnia.

• Inform patient (and significant other if appropriate) that drug may cause psychological and physical dependence and should be used only as prescribed and needed.

• Caution patient to avoid driving and other hazardous activities on day after taking drug, until he knows how it affects concentration and alertness.

• Instruct patient not to drink alcohol.

• Advise patient not to smoke or use herbs without consulting prescriber.

• Instruct patient to report suspected pregnancy.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, herbs, and behaviors mentioned above.


A trademark for the drug temazepam.


a trademark for a hypnotic agent (temazepam).


Temazepam, see there.
References in periodicals archive ?
In branded pharmaceuticals, sales of the newly launched EXALGO and PENNSAID products more than offset a significant decline for Restoril and Tofranil, reflecting competition from generics.
They include the tricyclic antidepressants Anafranil clomipramine HCI, Pamelor nortriptyline HCI, Tofranil imipramine HCl USP and Tofranil-PM imipramine pamonte, as well as Restoril temazepam USP, abenzodiazepine hypnotic used to treat insomnia and associated depression/anxiety.
According to Bruce Ashman, director of marketing for Mallinckrodt's CNS line, "The acquisition of these products, especially the Tofranil-PM and Restoril 7.
Serax, Ativan, Xanax, Restoril or Prosom has failed to show similar functional improvement in anxiety, dementia or sleep disorder (NOTE: only Restoril and Prosom are FDA-approved for sleep).
The decline in branded products was largely attributable to Restoril, while the generics shortfall was due to increased competitive activity, difficult comparisons with the prior year and distributor order timing.
Aerosol Sedatives Restoril, Temazepam Temazepam Sandoz Pharmaceuti- cals Corp.
Restoril is a registered trademark of Novartis Pharma Canada Inc.
5 mg formulation of Restoril has taken off since Mallinckrodt Pharmaceuticals acquired the brand from Novartis in 2001," says Frost & Sullivan Research Analyst Patrick Rajan.
In clinical studies, this milk peptide has been shown to be as effective as Valium(R), Xanax(R), Restoril and has been shown to be more effective than Kava-Kava and St.