Question from a Member:
Are there hypnotics in the US that are indicated for more than 1 month or 3 months or 6 months?
Unfortunately, the FDA does not specifically say that certain medications are approved for the longer-term treatment of insomnia. But, the wordings of the FDA indications for medications for the treatment of insomnia comment on the duration of treatment in several ways:
- Saying that the medication is indicated for the “short-term treatment” of insomnia.
- NOT saying that the medication is indicated for the “short-term treatment” of insomnia, i.e., not explicitly limiting the indication. An example of this is suvorexant (Belsomra®).
- Referring in the wording of the indication to the duration of the clinical trials that supported the FDA-approval.
From the Prescribing Information of various medications approved by the FDA for the treatment of insomnia, here are the ones whose indication refers specifically to use beyond the “short-term”, which generally means something like two weeks.
Doxepin (Silenor®): “The clinical trials performed in support of efficacy were up to 3 months in duration…”
Eszopiclone (Lunesta®): “The clinical trials performed in support of efficacy were up to 6 months in duration.”
Ramelteon (Rozerem®): “The clinical trials performed in support of efficacy were up to six months in duration.”
Zaleplon (Sonata®): “Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies … The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration.”
Zolpidem CR (Ambien CR®): “The clinical trials performed in support of efficacy were up to 3 weeks(using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration…”
Below are verbatim descriptions of the FDA indications for some—not all; I got tired of it after a while 🙂 —of the medications (alphabetically) that are FDA-approved for the treatment of insomnia. For a full list of medications approved by the FDA for the treatment of insomnia, see this page.
The text in quotes (” “) is taken from the official Prescribing Information, to which links are provided. The information on this page is verified as correct as of March 2019.
The FDA indication is described in two parts: from the “Highlights of Prescribing Information” (if available; sometimes not available, especially for medications approved by the FDA a long time ago) and from the “full” Prescribing Information.
Emphases in bold and/or color have been added by SPMH.
Doxepin (Silenor®)
Doxepin (Silenor®) Prescribing Information
From the Highlights: “INDICATIONS AND USAGE. Silenor (doxepin) tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance.”
From the full Prescribing Information: “INDICATIONS AND USAGE.
Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in
support of efficacy were up to 3 months in duration [see Clinical
Studies…”
Eszopiclone (Lunesta®)
Lunesta Prescribing Information
From the Highlights: “LUNESTA is indicated for the treatment of insomnia. LUNESTA has been shown to decrease sleep latency and improve sleep maintenance.”
From the full Prescribing Information: “LUNESTA® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).”
Ramelteon (Rozerem®)
Ramelteon (Rozerem®) Prescribing Information
From the Highlights: “INDICATIONS AND USAGE. ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.”
From the full Prescribing Information: “INDICATIONS AND USAGE. ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies…”
Suvorexant (Belsomra®)
Belsomra Prescribing Information
From the Highlights: “INDICATIONS AND USAGE. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.”
From the full Prescribing Information: “INDICATIONS AND USAGE
BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.”
Temazepam (Restoril®)
Restoril Prescribing Information
From the full Prescribing Information: “INDICATIONS AND USAGE. 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.”
Zaleplon (Sonata®)
Sonata Prescribing Information
From the full Prescribing Information:“INDICATIONS AND USAGE. Sonata is indicated for the short-term treatment of insomnia. Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.”
Zolpidem (Ambien®)
Prescribing Information for Ambien
The FDA-indication for Ambien was modified in March 2007.
From the Highlights: “Ambien is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.”
From the full Prescribing Information: “INDICATIONS AND USAGE. Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.”
Zolpidem CR (Ambien CR®)
Prescribing Information for Ambien CR
From the Highlights: “AMBIEN CR, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.”
From the full Prescribing Information: “INDICATIONS AND USAGE. AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration…”
Zolpidem sublingual (Edluar®, Intermezzo®)
Intermezzo Prescribing Information
From the Highlights: “Intermezzo is a GABA-A agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitation of Use: Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.”
From the full Prescribing Information: INDICATIONS AND USAGE. Intermezzo® (zolpidem tartrate) sublingual tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Use: Intermezzo is not indicated for the treatment of middle-of-the-night
insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.”
Related Pages
FDA-approved medications for the treatment of insomnia (hypnotics)
Practical tips on using hypnotics: Benzodiazepines
Temazepam (Restoril®): Basic Information
Practical tips on using hypnotics: the Z drugs
Hypnotic if waking up in the middle of the night?
Eszopiclone (Lunesta®): Basic Information
Zolpidem (Ambien® and Ambien CR®): Basic Information
Zaleplon (Sonata®): Basic Information
Non-addictive sleep medications
Best hypnotics in elderly patients?
Hypnotics to avoid in the elderly (older adults)
Which hypnotics to use or avoid in persons with sleep apnea
Does melatonin work for insomnia?
Low-dose preparations of melatonin
Which brand and preparation of melatonin to recommend?
What are the potential side effects of melatonin?
Can melatonin increase blood sugar?
Doxepin (Silenor®): Basic Information
Pros and cons of ramelteon (Rozerem) as a hypnotic
Ramelteon (Rozerem®): Basic Information
Suvorexant (Belsomra®): Basic Information
What are the BEST books on each topic related to psychiatry/ mental health?
Copyright 2019, Rajnish Mago, MD. All rights reserved. May not be reproduced in any form without express written permission.
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