Diazepam & Baclofen Vaginal Suppositories

Diazepam and baclofen suppositories are compounded prescription preparations inserted into the vagina or rectum. They can contain diazepam alone, baclofen alone, or both together. The combination prescribed most often is diazepam 5 mg with baclofen 10 mg, and single-agent diazepam 5 mg or 10 mg and baclofen 5 mg to 20 mg suppositories are also made. Some prescriptions add ketamine. Each batch is prepared by a licensed pharmacy to the strengths your prescriber orders.

Diazepam placed in the vagina is often called "vaginal Valium." Valium is the brand name of an FDA-approved oral diazepam tablet. A compounded diazepam suppository is not Valium, and it is not FDA-approved.

Prescribers order these suppositories for hypertonic (high-tone) pelvic floor dysfunction, in which the pelvic floor muscles stay tight and can cause pelvic pain, painful intercourse, or urinary and bowel symptoms. There is no FDA-approved vaginal or rectal suppository of diazepam, baclofen, or any combination of them, so the dosage form itself is unapproved. This page sets out what is actually known, including the findings that do not support it.

How does it work?

Diazepam is a benzodiazepine. It enhances the effect of GABA at GABA-A receptors, which relaxes muscle, reduces anxiety, and causes sedation, largely through the brain and spinal cord. Baclofen is a GABA-B agonist that acts at the spinal cord to reduce muscle spasticity. It is a muscle relaxant, not a benzodiazepine, and it is not a federally controlled substance. Ketamine, when a prescriber includes it, is an NMDA receptor antagonist added with the intent of addressing nerve pain.

The idea behind giving these vaginally or rectally is that the medication sits near the levator ani and obturator internus muscles and may help them relax. That is the reasoning, not a proven effect.

What is it used for?

Prescribers order these suppositories for hypertonic pelvic floor dysfunction and the symptoms that go with it, such as pelvic pain, painful intercourse, vaginismus, and levator ani spasm. They are usually intended as an adjunct to pelvic floor physical therapy, not as a treatment on their own. Prescribers also order diazepam suppositories for other reasons; this page focuses on pelvic floor use.

Benefit is not established for any of these uses, and Bayview makes no claim that these suppositories relieve pelvic pain, vaginismus, or painful intercourse. Only a licensed prescriber can decide whether to try them. Bayview Pharmacy does not provide consultations and does not determine whether a medication is appropriate for you; a valid prescription is required.

What does the evidence show?

Plainly: benefit is not established. The placebo-controlled trials of vaginal diazepam on its own found no difference from placebo.

• Crisp and colleagues, 2013. A triple-blinded trial in 21 women compared nightly 10 mg vaginal diazepam with placebo for 28 nights. There was no difference in resting pelvic floor muscle activity (EMG) at any time point and no difference on any validated questionnaire.
• Holland and colleagues, 2019. A double-blind trial randomized 49 women with levator muscle spasm to 10 mg diazepam or placebo capsules used vaginally, with pain measured at four weeks; 35 had complete four-week data. Pain scores did not differ between the groups (50 mm with diazepam and 39 mm with placebo on a 100 mm scale), and neither did questionnaire scores.
• Murina and colleagues, 2018. In 42 women with vestibulodynia, all of whom also used TENS, pain scores fell in both groups with no significant difference between them. Pain with intercourse and the ability to relax the pelvic floor after a contraction improved more with diazepam than with placebo. This is one small study of diazepam combined with another treatment.
• A 2020 systematic review (Stone and colleagues) found only five studies: two observational studies, in which most women reported improved sexual function without significant changes in pain (VAS) or sexual function (FSFI) scores, and the three small trials above. The authors concluded that more and larger studies are needed.
• Rectal diazepam. The only placebo-controlled trial we found (Aldrich and colleagues, 2022, 130 women randomized, 123 analyzed) gave one 10 mg rectal suppository after vaginal prolapse surgery. It did not reduce pain or opioid use, and the authors did not recommend adding it.
• Baclofen suppositories have no published randomized trial results. A placebo-controlled trial of 20 mg vaginal baclofen at the University of Louisville is listed as completed but had not posted results as of October 2026. The rest of the support is case series and conference abstracts.
• Ketamine has no controlled evidence for this route or this indication.
• No society guideline endorses these. No urogynecology, urology, or gynecology society guideline recommends compounded diazepam or baclofen suppositories as standard therapy.

The honest bottom line is that pelvic floor physical therapy is the intervention with actual evidence for hypertonic pelvic floor dysfunction. If you are considering these suppositories, ask your prescriber how they fit alongside physical therapy rather than in place of it.

Diazepam alone, baclofen alone, or both?

Your prescriber chooses the ingredients. The options Bayview prepares are:

• Diazepam with baclofen. The most common choice, usually diazepam 5 mg with baclofen 10 mg, or 10 mg of each. Schedule IV, because of the diazepam.
• Diazepam alone. 5 mg or 10 mg per suppository, without baclofen. Schedule IV.
• Baclofen alone. Commonly 10 mg, or a custom strength from 5 mg to 20 mg. Baclofen is not a benzodiazepine and is not a controlled substance. It has its own risks, including drowsiness and a serious withdrawal syndrome if stopped suddenly, so it must be tapered.
• Diazepam and baclofen with ketamine. Ketamine is a Schedule III controlled substance, and the FDA has warned about compounded ketamine products (see below).

Vaginal diazepam can also be compounded as a cream or gel on request, which some prescribers order when a suppository does not suit the patient.

How is it used?

Use them exactly as your prescriber directs. As commonly prescribed, one suppository is inserted vaginally or rectally at bedtime, either nightly, every other night, or only on the nights it is needed, and dispensed in a 15-count or 30-count. Because diazepam has a long half-life, the authors of the absorption study suggested intermittent use rather than every night, for example around physical therapy sessions.

Some prescribers set a defined trial, for example a few weeks (the placebo-controlled trials ran about four weeks), rather than open-ended refills. Wash your hands before and after inserting. Because sedation is expected, bedtime dosing is common, and you should not drive or do anything requiring alertness until you know how it affects you, including the next morning. A panty liner can help with leakage from the base. These details describe common regimens and are not treatment recommendations; your prescriber sets the strengths, the schedule, and when to stop.

What strengths are made?

These suppositories are compounded to order. The options below are the ones prescribers request most often.

Strengths are listed for reference only. None has been shown in a randomized trial to reduce pain more than placebo, and listing them is not a statement that any of them works or that one is better than another.

Side effects & safety

Expect sedation. Drowsiness, fatigue, muscle weakness, and unsteadiness are the side effects reported most often for diazepam. Dizziness, impaired driving and coordination, falls, and problems with memory or concentration can also occur, and all of these are made worse by alcohol and by opioids. Because diazepam stays in the body for days, these effects can last into the next day and can build up with repeated doses. Do not drink alcohol while using these, and tell your prescriber about every medication you take, especially opioids, other sedatives, sleep medications, and muscle relaxants.

Extra caution is needed in older adults (benzodiazepines appear on the Beers criteria list of medications to avoid), and in people with breathing problems, liver impairment, or a history of substance use.

Baclofen can cause drowsiness and muscle weakness. Stopping baclofen abruptly can cause a serious withdrawal syndrome with seizures, fever, confusion, muscle stiffness, and hallucinations, so it should be tapered rather than stopped suddenly, and doses need care in kidney impairment.

Local effects include vaginal irritation, discharge, and leakage or staining from the suppository base. Avoid use in pregnancy and while breastfeeding unless you have had a clear conversation with your prescriber about it.

Who should not use it?

Do not use these if you are allergic to diazepam, baclofen, ketamine (in versions containing it), or any ingredient in the suppository base. Versions containing diazepam are not appropriate if you have a benzodiazepine allergy, acute narrow-angle glaucoma, severe breathing problems (respiratory insufficiency), sleep apnea, severe liver disease, or myasthenia gravis, and they should be avoided or used only with specific direction if you take opioids or have a history of benzodiazepine or other substance misuse. Avoid in pregnancy and lactation absent a clear discussion with your prescriber. Tell your prescriber about your full health history, your allergies, and everything you take, including alcohol and anything bought over the counter.

How should it be stored?

Store them according to your label, because it depends on the base. Polyethylene glycol (PEG) based suppositories are generally kept at controlled room temperature. Cocoa butter and other fatty-base suppositories are generally refrigerated at 2 to 8 °C, or at least kept below 25 °C, so they do not melt. Follow the storage instruction the pharmacy puts on your label.

Protect them from light and heat, and do not store them in a bathroom. Because diazepam is a controlled substance, keep them secured and out of the reach of children and anyone else in the household, and do not share them. Discard after the beyond-use date on the label, and dispose of unused suppositories through a drug take-back program.

Why is this compounded?

There is no FDA-approved vaginal or rectal suppository of diazepam, baclofen, or any combination of them. Diazepam is FDA-approved as oral tablets (Valium and generics), an oral solution, an injection, a rectal gel (Diastat, approved only for acute repetitive seizures), and a nasal spray and buccal film for seizure clusters. Baclofen is approved for oral use and as an intrathecal injection (Lioresal). Ketamine is approved as an injection, and esketamine as a nasal spray (Spravato). A suppository can therefore exist only as a compounded preparation. Some prescribers instead ask patients to insert an oral diazepam tablet vaginally; that is off-label use of an FDA-approved tablet, not a compounded product.

When a prescriber orders a suppository, Bayview Pharmacy prepares it as a 503A compounding pharmacy under USP <795> standards, at the strengths and in the base specified. Compounding makes the dosage form available; it does not make it effective. Compounded preparations are not FDA-approved. Related preparations include Vulvodynia Creams and Medication Tapering. The full list is in our compounded medications catalog.