Restoril (Temazepam) 30mg

Description

What is Restoril and how is it used?
Restoril is a prescription medicine used to treat symptoms of insomnia. Restoril may be used alone or with other medications.

Restoril belongs to a class of drugs called Sedative/Hypnotics.

It is not known if Restoril is safe and effective in children.

What are the possible side effects of Restoril?
Restoril may cause serious side effects including:

confusion,
agitation,
hostility,
hallucinations,
anxiety,
memory problems,
depressed mood, and
thoughts of suicide or hurting yourself
Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Restoril include:

day-time drowsiness or “hangover” feeling,
headache,
dizziness,
tiredness,
nausea, and
feeling nervous
Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Restoril. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

DESCRIPTION
Restoril™ (temazepam) is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:

Restoril™ (temazepam) Structural Formula Illustration

C16H13ClN2O2 MW = 300.74
Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP.

Restoril™ (temazepam) Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration.

7.5 mg, 15 mg, 22.5 mg, and 30 mg Capsules
Active Ingredient: temazepam USP

7.5 mg Capsules
Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.

May also include: n-butyl alcohol, iron oxide red, shellac, shellac glaze, SD-35A alcohol.

15 mg Capsules
Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.

May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.

INDICATIONS
Restoril™ (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days).

For patients with short-term insomnia, instructions in the prescription should indicate that Restoril™ (temazepam) should be used for short periods of time (7 to 10 days).

The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.

DOSAGE AND ADMINISTRATION
While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

HOW SUPPLIED
Restoril™ (temazepam) Capsules USP
7.5 mg
Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and® on the other side in red, and a blue cap imprinted “RESTORIL 7.5 mg” twice in red.

Bottle of 30 – NDC 0406-9915-03
Bottle of 100 – NDC 0406-9915-01

15 mg
Maroon and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and® on the other side in red, and a maroon cap imprinted “RESTORIL 15 mg” twice in white.

Bottle of 100 – NDC 0406-9916-01

22.5 mg
Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and® on the other side in red, and an opaque blue cap imprinted “RESTORIL 22.5 mg” twice in red.

Bottle of 30 – NDC 0406-9914-03

30 mg
Maroon and blue capsules, with the blue body imprinted “FOR SLEEP” on one side and® on the other side in red, and a maroon cap imprinted “RESTORIL 30 mg” twice in white.

Bottle of 100 – NDC 0406-9917-01

Dispense in a well-closed, light-resistant container with a child-resistant closure.

Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].