Generic Restoril 15 mg

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Description

Restoril 15 mg is a capsule containing 15 mg of Temazepam, a benzodiazepine approved for the short-term treatment of insomnia, usually for 7 to 10 days. The label names 15 mg as the usual adult dose, taken before bedtime. Some patients need only 7.5 mg, and a few need 30 mg. The capsule is maroon and pink and carries the words “FOR SLEEP” on its body, which reflects its single purpose. This page explains how Restoril 15 mg works, how to take it, what clinical trials showed about side effects, the boxed and pregnancy warnings, its drug interactions, how to stop it safely, and how temazepam prescriptions are filled.

Note: Restoril 15 mg is a Schedule IV controlled substance. It is available only with a valid prescription from a licensed prescriber. This page summarizes the FDA-approved labeling for general education and is not a substitute for individual medical advice.

Restoril 15 mg Capsule Details

Attribute Restoril 15 mg
Active ingredient Temazepam 15 mg
Dosage form Hard gelatin capsule
Capsule appearance (brand) Maroon cap printed “RESTORIL 15 mg” in white; pink body printed “FOR SLEEP” and the “M” logo in red
Other strengths 7.5 mg, 22.5 mg and 30 mg
Class Benzodiazepine hypnotic
Labeled use Short-term treatment of insomnia (generally 7–10 days)
Peak plasma level 1.2–1.6 hours (mean about 1.5 hours)
Elimination half-life 3.5–18.4 hours (mean 8.8 hours)
Metabolism Conjugated (glucuronidated) to inactive compounds; 80–90% excreted in urine
Protein binding About 96%
Controlled class DEA Schedule IV

A Sleep Medicine Designed for Short Courses

Temazepam’s label states that it is indicated for short-term insomnia, usually 7 to 10 days. Its clinical trials lasted two weeks, and the Medication Guide notes that it is not known whether Restoril is safe and effective for use longer than 2 weeks. The label also says that if insomnia does not improve after 7 to 10 days of treatment, the cause may be an underlying medical or psychiatric illness that should be evaluated, such as depression, chronic pain, sleep apnea, restless legs, anxiety, or the effects of other medicines or substances.

That framing matters. Restoril 15 mg is typically prescribed for a defined stretch of poor sleep: after a hospital stay, during an acute stressful event, or while a longer-term plan for chronic insomnia gets under way. It is not designed to be the only answer to years of disrupted sleep.

What a Typical Short Course Looks Like

Stage What usually happens
Night 1–3 Sleep onset is faster and there are fewer awakenings. This is when next-morning grogginess is most likely, so check alertness before driving.
Night 4–7 The body settles into the routine. Keep a brief sleep diary of bedtime, time to fall asleep, awakenings and morning alertness.
Around day 7–10 Review with the prescriber. If sleep has improved, the capsule is usually stopped or reduced. If not, the underlying cause of the insomnia is looked into.
First nights after stopping One or two restless nights (rebound insomnia) are common and usually pass without treatment.

This outline describes a common pattern only. The prescriber sets the actual length of treatment and the number of capsules dispensed.

How Temazepam Promotes Sleep

Temazepam binds to the benzodiazepine site of the GABA-A receptor and increases the calming effect of GABA in the brain. This shortens the time it takes to fall asleep, reduces the number of nighttime awakenings, and increases total sleep time. The liver joins temazepam to glucuronic acid and makes it inactive. The body does not produce long-lasting active by-products, so next-day effects mostly depend on the person’s own half-life, which ranges widely from about 3.5 to 18 hours.

Is 15 mg the Right Dose? Label Dosing Explained

Patient Label recommendation Comment
Most adults 15 mg before retiring The usual dose
Adults with transient insomnia 7.5 mg may be enough A lower dose may give enough benefit with less next-day effect
Some adults 30 mg may be needed Decided by the prescriber after the response to 15 mg
Older or debilitated patients Start with 7.5 mg until the individual response is known 15 mg is not the usual starting dose here
Under 18 years Safety and effectiveness not established

Response to the same capsule strength can vary a lot from one person to the next. Our page on why some people need less medication explains the factors involved.

Restoril 15 mg Compared with the Other Capsule Strengths

Each Restoril strength has its own color scheme, which helps when a prescriber changes the dose or a taper uses a lower capsule.

Strength Brand capsule colors Typical place in treatment
7.5 mg Blue and pink Older adults, transient insomnia, taper step
15 mg Maroon and pink Usual adult dose
22.5 mg Blue Intermediate adjustment
30 mg Maroon and blue Highest labeled dose, for selected adults

What to Tell the Prescriber Before Starting

Several conditions change whether temazepam is suitable or what dose is safe. Mention all of the following at the appointment:

  • Pregnancy, the possibility of pregnancy, or breastfeeding
  • Any opioid, other benzodiazepine, sleep aid, antidepressant, antipsychotic or seizure medicine, including over-the-counter “PM” products
  • Snoring, pauses in breathing, COPD or other lung problems
  • Past or current depression, or thoughts of self-harm
  • Any history of alcohol or drug misuse
  • Liver or kidney disease
  • Past sleepwalking or other unusual behavior during sleep
  • Work schedules that start early or involve driving or heavy machinery

The answers help the prescriber choose between 7.5 mg and 15 mg, set the length of the course, and decide whether another approach to insomnia would be safer.

Bedtime Checklist for Restoril 15 mg

Temazepam reaches its peak about 1.5 hours after a dose. Because of this, many prescribers suggest taking it shortly before bed instead of the moment the lights go out. The exact timing should match the prescriber’s instructions.

  1. Check the sleep window. Take the capsule only if a full night (7 to 8 hours) is available before you need to be alert.
  2. Skip alcohol that evening completely.
  3. Get ready for bed first: lock up, set the alarm, charge your phone, and put car keys out of reach.
  4. Swallow one capsule whole with water. Do not open it.
  5. Go to bed and stay there. Do not do activities that need alertness after taking the dose.
  6. Never repeat the dose during the same night, even after waking early.
  7. In the morning, check how alert you feel before driving or using machinery.

Taking a sleep capsule twice in one night by mistake is a known error, especially in households where more than one person takes medicine. Common medication mistakes covers ways to prevent it.

Side Effects: What Clinical Trials Found

In controlled trials, the reactions reported in at least 1% of temazepam patients were close to the placebo rates. Drowsiness was the clearest drug effect:

Adverse reaction Temazepam Placebo
Drowsiness 9.1% 5.6%
Headache 8.5% 9.1%
Fatigue 4.8% 4.7%
Dizziness 4.5% 3.3%

Other reported effects include nervousness, lethargy, hangover feeling, anxiety, nausea, diarrhea, confusion, euphoria and weakness. Less common effects include vertigo, memory problems, nightmares and blurred vision. Paradoxical reactions such as agitation, excitement or aggression are uncommon but should be reported right away.

Next-Morning Effects

Because temazepam’s half-life varies so much, some people wake feeling refreshed while others feel heavy-headed until midday. Older adults are especially likely to have lingering sedation, unsteady walking and falls. A tired feeling during the day may also have other causes unrelated to the capsule, which are listed in why you may feel more tired than usual. For guidance on driving after sleep medicines, see the NHTSA drug-impaired driving page.

Complex Sleep Behaviors

The label warns that people taking sedative-hypnotics such as temazepam have done things while not fully awake and later had no memory of them. Examples include driving (“sleep-driving”), preparing and eating food, making phone calls and having sex. These events can happen in people with no history of them. The risk rises with alcohol, other central nervous system depressants, and doses above the prescribed amount. Anyone who has an episode like this should stop the medicine and tell the prescriber.

Boxed Warning

Restoril carries the benzodiazepine-class boxed warning:

  • Concomitant opioid use: Taking temazepam with opioids can cause profound sedation, respiratory depression, coma and death. Prescribe the combination only when alternatives are inadequate, and limit doses and duration.
  • Abuse, misuse and addiction: These can lead to overdose or death, particularly when combined with alcohol, opioids or illicit drugs.
  • Dependence and withdrawal: Regular use can produce physical dependence. Abrupt stopping or rapid dose reduction can cause life-threatening withdrawal reactions. Taper the dose gradually.

Background is available in the FDA benzodiazepine class safety communication.

Poor sleep is common during opioid treatment for pain, which is one reason this combination comes up. Anyone taking an opioid should tell every prescriber about it before a sleep medicine is considered. Opioids can disturb sleep on their own, as described in how oxycodone affects sleep, and the combined breathing risk is explained in oxycodone drug interactions.

Pregnancy: A Labeled Contraindication

Unlike most benzodiazepine labels, the Restoril label lists pregnancy as a contraindication. Temazepam should not be used by people who are pregnant. Anyone who could become pregnant should be told about the potential risk to the fetus. If pregnancy is planned or discovered while taking it, the prescriber should be contacted promptly to discuss stopping. Benzodiazepine use near delivery has also been linked to sedation and withdrawal in newborns. Temazepam passes into breast milk, so its use while breastfeeding needs a discussion with the prescriber.

Who Needs Extra Care with Restoril 15 mg

  • Older adults: Higher risk of confusion, oversedation and falls. The label’s starting dose for them is 7.5 mg.
  • Breathing problems: COPD, sleep apnea or other lung conditions, because of the risk of respiratory depression.
  • Depression: Benzodiazepines can worsen depression. Suicidal thinking needs urgent help through the 988 Lifeline.
  • Substance use history: Higher risk of misuse and dependence.
  • Liver or kidney impairment: May need closer monitoring.
  • Next-day safety-critical work: Pilots, drivers, machine operators and caregivers need to consider morning impairment.

Interactions to Discuss with the Pharmacist

Substance Risk with temazepam
Opioids (prescription pain medicines, some cough syrups) Profound sedation and slowed breathing
Alcohol Additive sedation, complex sleep behaviors, overdose risk
Other benzodiazepines and sleep medicines Duplicate sedation. These are generally not combined
Sedating antihistamines (diphenhydramine, doxylamine), including over-the-counter “PM” products Extra drowsiness and next-day impairment
Antipsychotics, sedating antidepressants, anticonvulsants, barbiturates, muscle relaxants Increased central nervous system depression
Herbal sedatives (valerian, kava) Possible added sedation

Alcohol deserves special mention. The NIAAA’s guide to alcohol-medicine interactions lists sleep medicines among the most dangerous combinations.

Stopping Restoril 15 mg

Even after a short course, the first night or two without temazepam can bring rebound insomnia: sleep that is temporarily worse than before treatment. This usually settles within a few nights. After longer or nightly use, stopping suddenly can cause withdrawal symptoms such as anxiety, restlessness, tremor, sweating and, rarely, seizures. The label calls for a gradual taper when discontinuing. One option is to step down to 7.5 mg before stopping, but the prescriber sets the actual schedule.

Building Sleep That Lasts

Because Restoril 15 mg is meant for short-term use, the best results come from pairing it with habits that improve sleep on their own:

  • Keep the same wake-up time every day, including weekends.
  • Use the bed only for sleep. Get up after about 20 minutes of lying awake.
  • Cut caffeine after midday and avoid alcohol near bedtime.
  • Get morning daylight and keep the bedroom dark, cool and quiet.
  • Ask about cognitive behavioral therapy for insomnia (CBT-I), the recommended first-line treatment for chronic insomnia. The American Academy of Sleep Medicine’s insomnia page explains it.

Overdose Warning Signs

A temazepam overdose can cause excessive sleepiness, confusion, slurred speech, poor coordination, slowed breathing, low blood pressure and coma. The danger increases sharply with opioids or alcohol. Call 911 if someone is difficult to wake or breathing slowly. Poison Control is available at 1-800-222-1222 and through webPOISONCONTROL.

Identifying, Storing and Disposing of Capsules

The brand Restoril 15 mg capsule is maroon and pink. The cap reads “RESTORIL 15 mg” and the body reads “FOR SLEEP.” Generic temazepam 15 mg capsules are made by several manufacturers and may use different colors and markings. If a new fill looks different, ask the pharmacist to confirm it. Why generic medicines look different explains why this happens.

  • Store at 68°F–77°F (20°C–25°C) in a well-closed, light-resistant container.
  • Keep capsules secured and away from the nightstand to prevent a second dose taken half-asleep.
  • Do not share them. Temazepam is prescribed for one person only.
  • Dispose of leftover capsules through take-back programs or according to the FDA’s disposal instructions.

Prescription Rules for Restoril 15 mg

Temazepam is a Schedule IV medicine. A DEA-registered prescriber must issue the prescription for a legitimate medical reason. Federal rules allow up to five refills within six months if they are authorized (21 CFR 1306.22). Because Restoril is meant for short-term insomnia, many prescribers write small quantities with few or no refills. Pharmacists may check the prescription drug monitoring program before dispensing, as described in how pharmacies verify controlled prescriptions. Controlled prescriptions also expire after a set time, as explained in why prescriptions expire.

Restoril 15 mg FAQ

How long does it take Restoril 15 mg to work?

Peak blood levels arrive about 1.2 to 1.6 hours after a dose. Many people feel drowsy within 30 to 60 minutes.

How long does Restoril 15 mg last?

The average half-life is about 8.8 hours, but it ranges from 3.5 to 18.4 hours. That is why some people feel effects into the next morning.

Is Restoril 15 mg a strong sleeping pill?

It is the usual adult dose, in the middle of the 7.5 mg to 30 mg range. For older adults, the label recommends starting at 7.5 mg.

How many nights can Restoril 15 mg be taken?

The label describes short-term use, generally 7 to 10 days. Its safety and effectiveness beyond 2 weeks have not been established, so longer use calls for a reassessment by the prescriber.

What if I wake at 3 a.m. after taking Restoril 15 mg?

Do not take another capsule. A second dose leaves too much temazepam in the body by morning and raises the risk of falls and next-day impairment. Mention frequent early waking to the prescriber.

Can the capsule be opened?

Swallow the capsule whole unless the prescriber or pharmacist gives other instructions.

Is temazepam 15 mg the same as Restoril 15 mg?

Generic temazepam 15 mg capsules contain the same active ingredient and strength and meet FDA equivalence standards. Their color and markings may differ.

Can Restoril 15 mg be taken during pregnancy?

No. The Restoril label lists pregnancy as a contraindication. Contact the prescriber right away if pregnancy is possible.

What happens after stopping Restoril 15 mg?

One or two nights of rebound insomnia are common. After longer use, a gradual taper helps prevent withdrawal symptoms.

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